11790 Federal Register / Vol. 76, No. 42 / Thursday, March 3, 2011 / Notices 

Affairs, Food and Drug Administration, 

5600 Fishers Lane, Rockville, MD 

20857, 240–632–6844. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 306(a)(2)(B) of the FD&C Act 

(21 U.S.C. 335a(a)(2)(B)) requires 

debarment of an individual if FDA finds 

that the individual has been convicted 

of a felony under Federal law for 

conduct otherwise relating to the 

regulation of any drug product under 

the FD&C Act. 

On September 28, 2007, the U.S. 

District Court District of New Jersey 

entered judgment against Dr. Poet for 13 

counts of mail fraud in violation of 18 

U.S.C. 2 and 1341 and 1 count of 

causing a drug to be misbranded while 

it was held for sale after shipment in 

interstate commerce with the intent to 

defraud or mislead in violation of 21 

U.S.C. 331(k), 333(a)(2), and 352(i)(3). 

FDA’s finding that debarment is 

appropriate is based on the felony 

convictions referenced herein for 

conduct relating to the regulation of a 

drug product. The factual basis for those 

convictions is as follows: During 2003– 

2004, Dr. Poet was a physician licensed 

to practice medicine in the State of New 

Jersey. Dr. Poet owned and operated the 

Shore Laser Center and PEAU, both 

located in New Jersey. As part of his 

practice, Dr. Poet injected patients with 

BOTOX, a Botulinum Toxin Type A 

drug. 

From on or about December 4, 2003, 

through in or about December 2004, Dr. 

Poet knowingly and willfully devised a 

scheme and artifice to defraud and to 

obtain money and property by means of 

false and fraudulent pretenses, 

representations, and promises. He 

maintained a Web site and placed 

regular advertisements in local 

newspapers offering BOTOX treatments 

at his office. Between December 4, 2003, 

and November 8, 2004, Dr. Poet placed 

13 orders for a total of 26 vials of TRI– 

Toxin, a Botulinum Toxin Type A drug 

manufactured by Toxin Research 

International, Inc. TRI–Toxin was 

labeled ‘‘For Research Purposes Only, 

Not for Human Use.’’ Dr. Poet injected 

many of the approximately 130 patients 

who sought BOTOX treatments with 

unapproved TRI–Toxin between January 

1, 2004, and December 1, 2004. As part 

of his scheme to defraud, Dr. Poet did 

not inform most of his patients receiving 

the TRI–Toxin injections that they were 

receiving injections of a product not 

approved by FDA. Dr. Poet charged 

patients the same price for the cheaper, 

unapproved TRI–Toxin and the 

approved BOTOX. For purposes of 

executing the scheme and artifice, Dr. 

Poet knowingly and willfully caused the 

TRI–Toxin to be delivered by private 

and commercial interstate carrier. 

As a result of his convictions, on 

December 13, 2010, FDA sent Dr. Poet 

a notice by certified mail proposing to 

permanently debar him from providing 

services in any capacity to a person that 

has an approved or pending drug 

product application. The proposal was 

based on a finding, under section 

306(a)(2)(B) of the FD&C Act, that Dr. 

Poet was convicted of felonies under 

Federal law for conduct relating to the 

regulation of a drug product under the 

FD&C Act. The proposal also offered Dr. 

Poet an opportunity to request a 

hearing, providing him 30 days from the 

date of receipt of the letter in which to 

file the request, and advised him that 

failure to request a hearing constituted 

a waiver of the opportunity for a hearing 

and of any contentions concerning this 

action. Dr. Poet failed to respond within 

the timeframe prescribed by regulation 

and has, therefore, waived his 

opportunity for a hearing and waived 

any contentions concerning his 

debarment (21 CFR part 12). 

II. Findings and Order 

Therefore, the Director, Office of 

Enforcement, Office of Regulatory 

Affairs, under section 306(a)(2)(B) of the 

FD&C Act, under authority delegated to 

the Director (Staff Manual Guide 

1410.35), finds that Albert Poet has been 

convicted of a felony under Federal law 

for conduct relating to the regulation of 

a drug product under the FD&C Act. 

As a result of the foregoing finding, 

Dr. Poet is permanently debarred from 

providing services in any capacity to a 

person with an approved or pending 

drug product application under sections 

505, 512, or 802 of the FD&C Act (21 

U.S.C. 355, 360b, or 382), or under 

section 351 of the Public Health Service 

Act (42 U.S.C. 262) (see DATES) (see 

sections 306(c)(1)(B) and (c)(2)(A)(ii), 

and 201(dd) of the FD&C Act (21 U.S.C. 

321(dd))). Any person with an approved 

or pending drug product application 

who knowingly employs or retains as a 

consultant or contractor, or otherwise 

uses the services of Dr. Poet, in any 

capacity during Dr. Poet’s debarment, 

will be subject to civil money penalties 

(section 307(a)(6) of the FD&C Act (21 

U.S.C. 335b(a)(6))). If Dr. Poet provides 

services in any capacity to a person with 

an approved or pending drug product 

application during his period of 

debarment he will be subject to civil 

money penalties (section 307(a)(7) of the 

FD&C Act). In addition, FDA will not 

accept or review any abbreviated new 

drug applications submitted by or with 

the assistance of Dr. Poet during his 

period of debarment (section 

306(c)(1)(B) of the FD&C Act). 

Any application by Dr. Poet for 

special termination of debarment under 

section 306(d)(4) of the FD&C Act 

should be identified with Docket No. 

FDA–2010–N–0478 and sent to the 

Division of Dockets Management (see 

ADDRESSES). All such submissions are to 

be filed in four copies. The public 

availability of information in these 

submissions is governed by 21 CFR 

10.20(j). 

Publicly available submissions may 

be seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

Dated: February 16, 2011. 

Howard Sklamberg, 

Director, Office of Enforcement, Office of 

Regulatory Affairs. 

[FR Doc. 2011–4778 Filed 3–2–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–1981–N–0077 (formerly 

81N–0393), FDA–1981–N–0248 (formerly 

81N–0396), FDA–1982–N–0046 (formerly 

82N–0095), FDA–1982–N–0264 (formerly 

82N–0096), and FDA–1983–N–0137 

(formerly 83N–0095); DESI 6514, 11935, and 

12152] 

Drugs for Human Use; Drug Efficacy 

Study Implementation; Oral 

Prescription Drugs Offered for Relief of 

Symptoms of Cough, Cold, or Allergy; 

Withdrawal of Hearing Requests; Final 

Resolution of Dockets 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that all outstanding hearing requests 

pertaining to oral prescription drugs 

offered for relief of symptoms of cough, 

cold, or allergy, Docket Nos. FDA–1981– 

N–0077 (formerly 81N–0393), FDA– 

1981–N–0248 (formerly 81N–0396), 

FDA–1982–N–0046 (formerly 82N– 

0095), FDA–1982–N–0264 (formerly 

82N–0096), and FDA–1983–N–0137 

(formerly 83N–0095), have been 

withdrawn. Therefore, shipment in 

interstate commerce of the products 

identified in those dockets, or any 

identical, related, or similar (IRS) 

product that is not the subject of an 

approved new drug application (NDA) 

or abbreviated new drug application 

(ANDA) (other than an over-the-counter 

(OTC) product that complies with an 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 76, No. 42 / Thursday, March 3, 2011 / Notices 11791 

1For background on the DESI review in general 

and the DESI review as it relates to the dockets 

addressed in this notice, please see the January 7, 

2011, notice. 

2 In the January 7, 2011, notice, FDA stated that 

with respect to Docket No. FDA–1982–N–0225 

(formerly 82N–0078), Chlor-Trimeton Repetabs 

Tablets, containing 12 milligrams (mg) 

chlorpheniramine maleate and marketed under 

NDA 7–638, had been discontinued. FDA notes that 

NDA 7–638 is currently active; however, products 

under it are not marketed for indications found 

ineffective under DESI. 

applicable OTC monograph), is 

unlawful as of the effective date of this 

notice. 

DATES: Effective Date: This notice is 

effective March 3, 2011. 

ADDRESSES: All communications in 

response to this notice should be 

identified with the appropriate docket 

number, and directed to Sakineh 

Walther, Division of New Drugs and 

Labeling Compliance, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Avenue, Bldg. 51, rm. 5242, 

Silver Spring, MD 20993–0002. 

FOR FURTHER INFORMATION CONTACT: 

Sakineh Walther, Division of New Drugs 

and Labeling Compliance, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 5242, 

Silver Spring, MD 20993–0002, 301– 

796–3349, e-mail: 

sakineh.walther@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In a notice published in the Federal 

Register of January 7, 2011 (76 FR 1174) 

(the January 7, 2011, notice), FDA 

announced that all outstanding hearing 

requests pertaining to certain dockets 

established under the Agency’s Drug 

Efficacy Study Implementation (DESI) 

program had been withdrawn.1 2 Also in 

that notice, FDA announced the 

withdrawal of certain hearing requests 

pertaining to Docket Nos. FDA–1981– 

N–0077 (formerly 81N–0393), FDA– 

1981–N–0248 (formerly 81N–0396), 

FDA–1982–N–0046 (formerly 82N– 

0095), FDA–1982–N–0264 (formerly 

82N–0096), and FDA–1983–N–0137 

(formerly 83N–0095), and offered an 

opportunity for companies with 

outstanding hearing requests under 

those dockets to withdraw or affirm 

their outstanding hearing requests. 

A. Docket No. FDA–1981–N–0077 

(formerly 81N–0393) (DESI 6514) 

The products reviewed under Docket 

No. FDA–1981–N–0077 (formerly 81N– 

0393) (DESI 6514) were Phenergan 

Expectorant with Codeine (containing 

promethazine hydrochloride, ipecac 

fluidextract, potassium 

guaiacolsulfonate, citric acid, sodium 

citrate, and codeine phosphate, 

marketed under NDA 8–306); Phenergan 

VC Expectorant Plain (containing 

promethazine hydrochloride, ipecac 

fluidextract, potassium 

guaiacolsulfonate, citric acid, sodium 

citrate, and phenylephrine 

hydrochloride, marketed under NDA 8– 

306); Phenergan VC Expectorant With 

Codeine (containing promethazine 

hydrochloride, ipecac fluidextract, 

potassium guaiacolsulfonate, citric acid, 

sodium citrate, phenylephrine 

hydrochloride, and codeine phosphate, 

marketed under NDA 8–306); Phenergan 

Expectorant Plain (containing 

promethazine hydrochloride, ipecac 

fluidextract, potassium 

guaiacolsulfonate, citric acid, and 

sodium citrate, marketed under NDA 8– 

604); and Pediatric Phenergan 

Expectorant with Dextromethorphan 

(containing promethazine 

hydrochloride, ipecac fluidextract, 

potassium guaiacolsulfonate, citric acid, 

sodium citrate, and dextromethorphan 

hydrobromide, marketed under NDA 

11–265). In a notice published in the 

Federal Register of May 25, 1982 (47 FR 

22610), FDA revoked the temporary 

exemption that permitted these drug 

products, and those products IRS to 

these products, to remain on the market 

beyond the time limit established for 

DESI. The notice also reclassified the 

products to lacking substantial evidence 

of effectiveness, and offered an 

opportunity for a hearing on a proposal 

to withdraw approval of the NDAs for 

the products. 

After Wyeth Laboratories, the holder 

of the NDAs for the Phenergan products, 

withdrew its hearing request after 

approval of reformulated versions of 

four of its five products, FDA 

announced in the Federal Register of 

August 15, 1984 (49 FR 32681) that the 

Agency was withdrawing approval of 

NDAs 8–306, 8–604, and 11–265 

pertaining to the old formulations of the 

Phenergan products, effective 

September 14, 1984. 

At the time of the January 7, 2011, 

notice (76 FR 1174), there were two 

outstanding hearing requests under this 

docket filed by Bay Laboratories, 3654 

West Jarvis, Skokie, IL 60076, for its IRS 

products Promethazine Expectorant 

with Codeine, Promethazine VC 

Expectorant Plain, Promethazine VC 

Expectorant with Codeine, 

Promethazine Expectorant Plain, and 

Promethazine Pediatric Expectorant, 

and by National Pharmaceuticals, Inc., 

7205 Windsor Blvd., Baltimore, MD 

21207, for its products IRS to all five 

Phenergan products considered under 

this docket. FDA was unable to find 

current contact information for Bay 

Laboratories and National 

Pharmaceuticals. In the January 7, 2011, 

notice, FDA gave these companies an 

opportunity to affirm or withdraw their 

hearing requests. Requests that were not 

affirmed within 30 days of that notice 

were to be deemed withdrawn by FDA. 

B. Docket FDA–1981–N–0248 (formerly 

81N–0396) (DESI 6514) 

The products reviewed under Docket 

No. FDA–1981–N–0248 (formerly 81N– 

0396) (DESI 6514) were Dimetane 

Expectorant (containing 

brompheniramine maleate, 

phenylephrine hydrochloride, 

phenylpropanolamine hydrochloride, 

and guaifenesin, marketed under NDA 

11–694); Dimetane Expectorant-DC 

(containing codeine phosphate, 

brompheniramine maleate, 

phenylephrine hydrochloride, 

phenylpropanolamine hydrochloride, 

and guaifenesin, marketed under NDA 

11–694); and Actifed-C Expectorant 

(containing codeine phosphate, 

triprolidine hydrochloride, 

pseudoephedrine hydrochloride, and 

guaifenesin, marketed under NDA 12– 

575). In a notice published in the 

Federal Register of May 25, 1982, FDA 

revoked the temporary exemption that 

permitted these drug products, and 

those products IRS to these products, to 

remain on the market beyond the time 

limit established for DESI. The notice 

also reclassified the products to lacking 

substantial evidence of effectiveness, 

and offered an opportunity for a hearing 

on a proposal to withdraw approval of 

the NDAs for the products. 

On April 3, 1984, A.H. Robins, the 

holder of the NDA for Dimetane 

Expectorant and Dimetane ExpectorantDC, withdrew its hearing request after 

approval of reformulated versions of its 

products. Accordingly, in the Federal 

Register of August 24, 1984 (49 FR 

33726), FDA announced that it was 

withdrawing approval of those portions 

of NDA 11–694 pertaining to the old 

formulations of the Dimetane 

Expectorant products, effective 

September 24, 1984. 

In the Federal Register of September 

14, 1984 (49 FR 36169), FDA announced 

that it was withdrawing approval of 

those portions of NDA 12–575 

pertaining to the old formulation of 

Actifed-C Expectorant, effective October 

15, 1984, after the NDA holder, 

Burroughs Wellcome, obtained approval 

for a reformulated version of the 

product and withdrew its hearing 

request. 

At the time of the January 7, 2011, 

notice, there were two outstanding 


srobinson on DSKHWCL6B1PROD with NOTICES
11792 Federal Register / Vol. 76, No. 42 / Thursday, March 3, 2011 / Notices 

hearing requests under this docket filed 

by Bay Laboratories, 3654 West Jarvis, 

Skokie, IL 60076, for its IRS products 

Triphen Expectorant, Triphen 

Expectorant DC, and Pseudodine ‘‘C’’ 

Expectorant, and by National 

Pharmaceuticals, Inc., 7205 Windsor 

Blvd., Baltimore, MD 21207, for its 

products IRS to Dimetane Expectorant, 

Dimetane Expectorant DC, and ActifedC. FDA was unable to find current 

contact information for Bay Laboratories 

and National Pharmaceuticals. In the 

January 7, 2011, notice, FDA gave these 

companies an opportunity to affirm or 

withdraw their hearing requests. 

Requests that were not affirmed within 

30 days of that notice were to be 

deemed withdrawn by FDA. 

C. Docket FDA–1982–N–0046 (formerly 

82N–0095) (DESI 6514, 11935) 

The products reviewed under Docket 

No. FDA–1982–N–0046 (formerly 82N– 

0095) (DESI 6514 and 11935) were 

Ambenyl Expectorant (containing 

codeine sulfate, 

bromodiphenhydramine hydrochloride, 

diphenhydramine hydrochloride, 

ammonium chloride, potassium 

guaiacolsulfonate, and menthol, 

marketed under NDA 9–319); and 

Pyribenzamine and Ephedrine Tablets 

(containing tripelennamine 

hydrochloride and 12 mg ephedrine 

sulfate, marketed under NDA 5–914). In 

a notice published in the Federal 

Register of May 25, 1982 (47 FR 22604), 

FDA revoked the temporary exemption 

that permitted these drug products, and 

those products IRS to these products, to 

remain on the market beyond the time 

limit established for DESI. The notice 

also reclassified the products to lacking 

substantial evidence of effectiveness, 

and offered an opportunity for a hearing 

on a proposal to withdraw approval of 

the NDAs for the products. 

In the Federal Register of May 24, 

1983 (48 FR 23311), FDA announced 

that it was withdrawing approval of 

NDA 5–914 as it pertains to 

Pyribenzamine and Ephedrine Tablets, 

effective June 23, 1983, because no 

hearing was requested for the product 

by the NDA holder. On February 27, 

1984, Marion Laboratories, the NDA 

holder for Ambenyl Expectorant, 

withdrew its hearing request after a 

reformulated version of its product was 

approved. Accordingly, in the Federal 

Register of August 24, 1984, FDA 

announced it was withdrawing approval 

of those portions of NDA 9–319 

pertaining to the old formulation of 

Ambenyl Expectorant, effective 

September 24, 1984. 

At the time of the January 7, 2011, 

notice, there was one outstanding 

hearing request under this docket filed 

by National Pharmaceuticals, Inc., 7205 

Windsor Blvd., Baltimore, MD 21207, 

for its products IRS to Ambenyl 

Expectorant. FDA was unable to find 

current contact information for National 

Pharmaceuticals. In the January 7, 2011, 

notice, FDA gave this company an 

opportunity to affirm or withdraw its 

hearing request. Its hearing request was 

to be deemed withdrawn if the company 

did not affirm the request within 30 

days of that notice. 

D. Docket FDA–1982–N–0264 (formerly 

82N–0096) (DESI 12152) 

The product reviewed under Docket 

No. FDA–1982–N–0264 (formerly 82N– 

0096) (DESI 12152) was Ornade 

Spansules. Ornade Spansules, as 

formulated early in the DESI review 

process, was a three-ingredient product 

containing 8 mg of chlorpheniramine 

maleate, 50 mg of phenylpropanolamine 

hydrochloride, and 2.5 mg of 

isopropamide, and was marketed under 

NDA 12–152. Subsequently, Ornade 

Spansules was reformulated as a 

controlled-release product containing 12 

mg chlorpheniramine maleate and 75 

mg phenylpropanolamine. In a notice 

published in the Federal Register of 

August 17, 1982 (47 FR 35870), FDA 

revoked the temporary exemption that 

permitted Ornade Spansules, as 

originally formulated, and those 

products IRS to it, to remain on the 

market beyond the time limit 

established for DESI. In the notice, FDA 

also announced the conditions for 

marketing Ornade Spansules, as 

reformulated, and the products IRS to it, 

for the indication for which they were 

regarded as effective, and offered an 

opportunity for a hearing concerning a 

proposal to withdraw approval of the 

NDA with respect to the old formulation 

and the indications reclassified to 

lacking substantial evidence of 

effectiveness. 

In the Federal Register of December 

12, 1984 (49 FR 48387), FDA announced 

that it was withdrawing approval of 

those portions of NDA 12–152 covering 

the old, three-ingredient formulation for 

Ornade Spansules, effective January 11, 

1985, noting that no party submitted a 

hearing request regarding the threeingredient formulation. 

At the time of the January 7, 2011, 

notice, there were two outstanding 

hearing requests under this docket filed 

by Pioneer Pharmaceuticals, Inc., 209 

40th Street, Irvington, NJ 07111, for its 

IRS product characterized by the 

company as a generic version of Ornade 

Spansules, and by Zenith Laboratories, 

Inc., 140 LeGrand Ave., Northvale, NJ 

07647, for its IRS product, a sustained 

release product containing 

chlorpheniramine and 

phenylpropanolamine. FDA did not 

receive any response to its attempt to 

contact Zenith Laboratories and was 

unable to find current contact 

information for Pioneer 

Pharmaceuticals, Inc. In the January 7, 

2011, notice, FDA gave these companies 

an opportunity to affirm or withdraw 

their hearing requests. Requests that 

were not affirmed within 30 days of that 

notice were to be deemed withdrawn by 

FDA. 

E. Docket FDA–1983–N–0137 (formerly 

83N–0095) (DESI 11935) 

The products reviewed under Docket 

No. FDA–1983–N–0137 (formerly 83N– 

0095) (DESI 11935) were Dimetapp 

Extentabs and Dimetapp Elixir. As 

originally formulated during the period 

of the DESI review, Dimetapp Extentabs 

contained 12 mg brompheniramine 

maleate, 15 mg phenylephrine 

hydrochloride, and 15 mg 

phenylpropanolamine hydrochloride in 

controlled-release form, and was 

marketed under NDA 12–436; and 

Dimetapp Elixir contained 4 mg 

brompheniramine maleate, 5 mg 

phenylephrine hydrochloride, and 5 mg 

phenylpropanolamine hydrochloride 

per 5 milliliters (mL), and was marketed 

under NDA 13–087. In a notice 

published in the Federal Register of 

December 23, 1983 (48 FR 56854) (the 

December 23, 1983, notice), FDA 

revoked the temporary exemption that 

permitted these drug products, and 

those products IRS to these products, to 

remain on the market beyond the time 

limit established for DESI, and offered 

an opportunity for a hearing concerning 

a proposal to withdraw approval of the 

NDAs for the original formulations of 

these products and for the indications 

reclassified to lacking substantial 

evidence of effectiveness. 

At the time of the publication of the 

December 23, 1983, notice, the 

manufacturer had submitted 

supplemental applications proposing to 

reformulate Dimetapp Extentabs to 

contain 12 mg brompheniramine 

maleate and 75 mg 

phenylpropanolamine hydrochloride in 

a controlled-release form, and Dimetapp 

Elixir to contain 4 mg brompheniramine 

maleate and 25 mg 

phenylpropanolamine hydrochloride 

per 5 mL. The supplements to NDA 12– 

436 and NDA 13–087 were approved by 

FDA on April 20, 1984, and March 29, 

1984, respectively. In the December 23, 

1983, notice, FDA also announced the 

conditions for marketing the 

reformulated versions of these products 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 76, No. 42 / Thursday, March 3, 2011 / Notices 11793 

for the indication for which they were 

regarded as effective. 

At the time of the January 7, 2011, 

notice (76 FR 1174), there were 14 

outstanding hearing requests under this 

docket filed by American Therapeutics 

Inc., 75 Carlough Rd., Bohemia, NY 

11716, for its product IRS to Dimetapp 

Extentab Tablets; Amide 

Pharmaceutical, Inc., 101 East Main St., 

Little Falls, NJ 07424, for its IRS product 

Ami-Tapp; Bay Laboratories, Inc., 3654 

West Jarvis, Skokie, IL 60076, for 

Triphen Elixir, its product IRS to 

Dimetapp Elixir; Carnrick Laboratories, 

Inc., 65 Horse Hill Rd., Cedar Knolls, NJ 

07927, for Nolamine Timed Release 

Tablets, its product IRS to Dimetapp 

Extentabs; Copley Pharmaceutical, Inc., 

398 West Second St., P.O. Box 107, 

Boston, MA 02127, for its products IRS 

to Dimetapp Extentabs; LuChem 

Pharmaceuticals, Inc., P.O. Box 6038, 

8910 Linwood Ave., Shreveport, LA 

71136, for its IRS products Ban-Tuss 

HC, Ban-Tuss C Expectorant, Tuss-Delay 

Tablets, Ban-Tuss Plain, Klerist-D 

Tablets, Respergen, Am-Tuss Liquid, 

Novadyne DH, Novadyne Expectorant, 

Dexophed Tablets, Chem-Tuss-SR, 

Chem-Tuss Elixir, Chem-Tuss DM, 

Chem-Tuss DME, and Chem-Tuss N; 

Mayrand Inc., 4 Dundas Circle, P.O. Box 

8860, Greensboro, NC 27419, for its 

products IRS to Dimetapp Extentabs and 

Dimetapp Elixir; National 

Pharmaceutical Manufacturing Co., 

7205 Windsor Blvd., Baltimore, MD 

21207, for its product IRS to Dimetapp 

Elixir; Pharmaceutical Basics, Inc., 301 

S. Cherokee, Denver, CO 80223, for its 

IRS product Basamine S.R. Tablets; 

Pioneer Pharmaceuticals, Inc., 209 40th 

St., Irvington, NJ 07111, for Pioten 

Tablets, its product IRS to Dimetapp 

Extentabs; Quantum Pharmics, Ltd., 26 

Edison St., Amityville, NY 11701, for its 

IRS product, Brom-Tapp; Superpharm 

Corp., 155 Oval Dr., Central Islip, NY 

11722, for its product IRS to Dimetapp 

Extentab Tablets; United States Trading 

Corp., 10718 McCune Ave., Los 

Angeles, CA 90034, for its products IRS 

to Dimetapp Extentabs; and UpsherSmith Laboratories, Inc., 14905 23d 

Ave. North, Minneapolis, MN 55441, for 

unspecified products. 

FDA was unable to find current 

contact information for American 

Therapeutics, Amide Pharmaceutical, 

Inc., Bay Laboratories, Inc., National 

Pharmaceutical Manufacturing Co., 

Pharmaceutical Basics, Inc., 

Superpharm Corp., and United States 

Trading Corp. FDA did not receive any 

response to its attempt to contact 

Carnrick Laboratories, a subsidiary of 

Elan Corp., PLC, 800 Gateway Blvd., 

South San Francisco, CA 94080; Copley 

Pharmaceutical, Inc.; LuChem 

Pharmaceuticals, Inc.; Merz 

Pharmaceuticals, LLC, P.O. Box 18806, 

Greensboro, NC 27419, successor to 

Mayrand Inc. Pharmaceuticals; Pioneer 

Pharmaceuticals, Inc.; Quantum 

Pharmics, Ltd.; or Upsher-Smith 

Laboratories, Inc. In the January 7, 2011, 

notice, FDA gave these companies an 

opportunity to affirm or withdraw their 

hearing requests. Requests that were not 

affirmed within 30 days of that notice 

were to be deemed withdrawn by FDA. 

II. Final Resolution of Docket Nos. 

FDA–1981–N–0077 (formerly 81N– 

0393), FDA–1981–N–0248 (formerly 

81N–0396), FDA–1982–N–0046 

(formerly 82N–0095), FDA–1982–N–264 

(formerly 82N–0096), and FDA–1983– 

N–0137 (formerly 83N–0095) 

The time period for responding to the 

January 7, 2011, notice has elapsed, and 

no companies with outstanding hearing 

requests responded to the notice. 

Because no outstanding hearing requests 

were affirmed in response to the January 

7, 2011, notice (or in response to FDA’s 

previous attempts to contact companies 

with outstanding hearing requests), all 

of the outstanding hearing requests 

pertaining to Docket Nos. FDA–1981– 

N–0077 (formerly 81N–0393), FDA– 

1981–N–0248 (formerly 81N–0396), 

FDA–1982–N–0046 (formerly 82N– 

0095), FDA–1982–N–0264 (formerly 

82N–0096), and FDA–1983–N–0137 

(formerly 83N–0095) are deemed to be 

withdrawn. Therefore, shipment in 

interstate commerce of the products 

identified in those dockets, or any IRS 

product that is not the subject of an 

approved NDA or ANDA, is unlawful as 

of the effective date of this notice. This 

notice is not applicable to OTC products 

that comply with an OTC monograph 

(21 CFR 310.6(f)). Any person who 

wishes to determine whether a specific 

product is covered by this notice should 

write to the Center for Drug Evaluation 

and Research (see ADDRESSES). 

III. Discontinued Products 

Some firms may have previously 

discontinued the manufacturing or 

distribution of products covered by this 

notice without removing them from the 

listing of their products under section 

510(j) of the Federal Food, Drug and 

Cosmetic Act (the FD&C Act) (21 U.S.C. 

360(j)). Other firms may discontinue 

manufacturing or marketing listed 

products in response to this notice. 

Firms that wish to notify the Agency of 

product discontinuation should send a 

letter, signed by the firm’s chief 

executive officer, fully identifying the 

discontinued product(s), including NDC 

number(s), and stating that the 

product(s) has (have) been 

discontinued. The letter should be sent 

to Sakineh Walther (see ADDRESSES). 

Firms should also update the listing 

of their products under section 510(j) of 

the FD&C Act to reflect discontinuation 

of unapproved products. FDA plans to 

rely on its existing records, including 

drug listing records or other available 

information, when it targets violations 

for enforcement action. Firms should be 

aware that, after the effective date of this 

notice, FDA intends to take enforcement 

action without further notice against 

any firm that manufactures or ships in 

interstate commerce any unapproved 

product covered by this notice that is 

not the subject of an ongoing DESI 

proceeding. 

IV. Reformulated Products 

Some of the active ingredients found 

in drug products covered by this notice 

are included in the OTC monograph in 

21 CFR part 341, ‘‘Cold, Cough, Allergy, 

Bronchodilator, and Antihistamine Drug 

Products for Over-the-Counter Human 

Use.’’ OTC products that comply with 

the monograph may be marketed 

without approval. 

However, FDA cautions firms against 

reformulating products into OTC 

products or different unapproved new 

drugs that are marketed under the same 

name or substantially the same name 

(including a new name that contains the 

old name). Reformulated products 

marketed under a name previously 

identified with a different active 

ingredient or combination of active 

ingredients have the potential to 

confuse health care practitioners and 

harm patients. 

This notice is issued under sections 

502 and 505 of the FD&C Act (21 U.S.C. 

352 and 355), and under authority 

delegated to the Assistant Commissioner 

for Policy under section 1410.21 of the 

FDA Staff Manual Guide. 

Dated: February 22, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–4702 Filed 3–2–11; 8:45 am] 

BILLING CODE 4160–01–P 


srobinson on DSKHWCL6B1PROD with NOTICES