Document ID: FDA-1981-N-0077-0005
Agency: fda
Document Type: Notice
Title: Drugs for Human Use: Drug Efficacy Study Implementation; Oral Prescription Drugs, etc.; Withdrawal of Hearing Requests; Final Resolution of Dockets
Posted Date: 2011-03-03T05:00Z

[Federal Register Volume 76, Number 42 (Thursday, March 3, 2011)]
[Notices]
[Pages 11790-11793]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-4702]

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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.

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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withdrawn.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

[[Page 11791]]

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.
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    \1\ For 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.
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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 Expectorant-DC, 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

[[Page 11792]]

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 Actifed-C. 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 three-ingredient 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

[[Page 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 Upsher-Smith 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