Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Notices 11487 

anticipate manufacturing dissolvable 

tobacco products will take 

approximately 1 hour to draft and send 

a letter to FDA indicating that they do 

not have documents to submit. These 

estimates were derived based upon FDA 

experience and feedback provided by 

public and stakeholder comments. 

The capital costs associated with this 

collection pertain to the postage for 

mailing documents in electronic or 

paper formats. Estimating these costs is 

problematic because the costs will vary 

depending on the size of the document 

production (e.g. one binder of 

documents vs. numerous boxes of 

paper) and the media type (e.g., compact 

disk (CD) or digital video disk) chosen 

to submit documents. Currently, we 

cannot identify how many documents 

will be submitted per response. 

Some sample postage costs are shown 

for different types of packages: 

• 10 CDs in a flat envelope weighing 

30 ounces: approximately $8.00 using 

first class business mail 

• 5-pound parcel containing paper 

documents: approximately $12 using 

business parcel post mail and delivering 

to the furthest delivery zone 

• 10-pound parcel containing paper 

documents: approximately $17 using 

business parcel mail and delivering to 

the furthest delivery zone 

• 50-pound parcel containing paper 

documents: approximately $52 using 

business parcel post mail and delivering 

to the furthest delivery zone. 

FDA estimates the capital costs 

associated with this document 

submission to be $924. The capital costs 

determined by this estimate are based 

upon 3 submissions for large 

manufacturers, 7 submissions for small 

to medium manufacturers, and 110 

submissions of 1 letter apiece for those 

who do not either manufacture 

dissolvable tobacco products or have 

documents pertaining to the 

manufacture of dissolvable tobacco 

products. 

For the three large manufacturers, it is 

estimated that each manufacturer will 

submit their documents electronically 

on the equivalent of one 500-gigabyte 

external hard drive of data. This is 

estimated to cost approximately $125 

per drive, and $20 to ship the drive, for 

a total of $435 (3 manufacturers × [$125 

+ $20]). 

For the 7 small to medium sized 

manufacturers, it is estimated that 5 

manufacturers (about 71 percent) will 

submit their documents electronically 

on the equivalent of 10 CD–ROMs. This 

is estimated to cost $20 for the 10 CD– 

ROM spindle, and $8 to ship each group 

of 10 CDs per envelope for a total of 

$140 (5 manufacturers × [$20 + $8]). The 

remaining two manufacturers will 

submit their documents via paper, 

which is estimated to cost $184 (2 

manufacturers × [$40 cost of one box of 

paper + $52 to ship the box of paper]). 

The total capital cost for small to 

medium manufacturers, therefore, is 

estimated to be $324 ($140 + $184). 

For the remaining 110 manufacturers 

who must submit a letter to FDA 

indicating that they do not have any 

documents, it is estimated that each 

manufacturer will use $1 of paper 

products and pay postage 

approximating a rounded figure of $0.50 

for a total of $165 (110 manufacturers × 

[$1.00 + $0.50]). Therefore, FDA 

estimates the total capital costs 

associated with this document 

submission to be $924. 

Dated: February 24, 2011. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2011–4613 Filed 3–1–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–P–0201] 

Determination That NILSTAT (Nystatin 

Powder (Oral, 100%)) Was Not 

Withdrawn From Sale for Reasons of 

Safety or Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

that NILSTAT (nystatin powder (oral, 

100%)) was not withdrawn from sale for 

reasons of safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for nystatin 

powder (oral, 100%) if all other legal 

and regulatory requirements are met. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer L. Stevens, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6316, 

Silver Spring, MD 20993–0002, 301– 

796–3602. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

(the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products approved 

under an ANDA procedure. ANDA 

applicants must, with certain 

exceptions, show that the drug for 

which they are seeking approval 

contains the same active ingredient in 

the same strength and dosage form as 

the ‘‘listed drug,’’ which is a version of 

the drug that was previously approved. 

ANDA applicants do not have to repeat 

the extensive clinical testing otherwise 

necessary to gain approval of a new 

drug application (NDA). The only 

clinical data required in an ANDA are 

data to show that the drug that is the 

subject of the ANDA is bioequivalent to 

the listed drug. 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)), which requires FDA to 

publish a list of all approved drugs. 

FDA publishes this list as part of the 

‘‘Approved Drug Products With 

Therapeutic Equivalence Evaluations,’’ 

which is generally known as the 

‘‘Orange Book.’’ Under FDA regulations, 

a drug is removed from the list if the 

Agency withdraws or suspends 

approval of the drug’s NDA or ANDA 

for reasons of safety or effectiveness or 

if FDA determines that the listed drug 

was withdrawn from sale for reasons of 

safety or effectiveness (21 CFR 314.162). 

Under § 314.161(a)(1) (21 CFR 

314.161(a)(1)), the Agency must 

determine whether a listed drug was 

withdrawn from sale for reasons of 

safety or effectiveness before an ANDA 

that refers to that listed drug may be 

approved. FDA may not approve an 

ANDA that does not refer to a listed 

drug. 

NILSTAT (nystatin powder (oral, 

100%)) is the subject of NDA 050576, 

held by Dava Pharmaceuticals, Inc., and 

was initially approved on December 22, 

1983. NILSTAT is indicated for the 

treatment of intestinal and oral cavity 

infections caused by Candida (Monilia) 

albicans. NILSTAT (nystatin powder 

(oral, 100%)) is currently listed in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. 

Paddock Laboratories, Inc., submitted 

a citizen petition dated April 8, 2010 

(Docket No. FDA–2010–P–0201), under 

21 CFR 10.30, requesting that the 

Agency determine whether NILSTAT 

(nystatin powder (oral, 100%)) was 

withdrawn from sale for reasons of 

safety or effectiveness. 

After considering the citizen petition 

and reviewing Agency records, FDA has 

determined under § 314.161 that 

NILSTAT (nystatin powder (oral, 

100%)) was not withdrawn for reasons 

of safety or effectiveness. The petitioner 

has identified no data or other 

information suggesting that NILSTAT 

(nystatin powder (oral, 100%)) was 


emcdonald on DSK2BSOYB1PROD with NOTICES
11488 Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Notices 

withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of NILSTAT 

(nystatin powder (oral, 100%)) from 

sale. We have also independently 

evaluated relevant literature and data 

for possible postmarketing adverse 

events and have found no information 

that would indicate that this product 

was withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list NILSTAT (nystatin 

powder (oral, 100%)) in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

delineates, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. ANDAs that refer 

to NILSTAT (nystatin powder (oral, 

100%)) may be approved by the Agency 

as long as they meet all other legal and 

regulatory requirements for the approval 

of ANDAs. If FDA determines that 

labeling for this drug product should be 

revised to meet current standards, the 

Agency will advise ANDA applicants to 

submit such labeling. 

Dated: February 24, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–4595 Filed 3–1–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0318] 

Determination That MEGACE 

(Megestrol Acetate) Tablets and Nine 

Other Drug Products Were Not 

Withdrawn From Sale for Reasons of 

Safety or Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

that the 10 drug products listed in this 

document were not withdrawn from 

sale for reasons of safety or 

effectiveness. This determination means 

that FDA will not begin procedures to 

withdraw approval of abbreviated new 

drug applications (ANDAs) that refer to 

these drug products, and it will allow 

FDA to continue to approve ANDAs that 

refer to the products as long as they 

meet relevant legal and regulatory 

requirements. 

FOR FURTHER INFORMATION CONTACT: 

Olivia Pritzlaff, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6308, 

Silver Spring, MD 20993–0002, 301– 

796–3601. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

(the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products approved 

under an ANDA procedure. ANDA 

applicants must, with certain 

exceptions, show that the drug for 

which they are seeking approval 

contains the same active ingredient in 

the same strength and dosage form as 

the ‘‘listed drug,’’ which is a version of 

the drug that was previously approved. 

ANDA applicants do not have to repeat 

the extensive clinical testing otherwise 

necessary to gain approval of a new 

drug application (NDA). The only 

clinical data required in an ANDA are 

data to show that the drug that is the 

subject of the ANDA is bioequivalent to 

the listed drug. 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act) (21 U.S.C. 355(j)(7)), which 

requires FDA to publish a list of all 

approved drugs. FDA publishes this list 

as part of the ‘‘Approved Drug Products 

With Therapeutic Equivalence 

Evaluations,’’ which is generally known 

as the ‘‘Orange Book.’’ Under FDA 

regulations, a drug is withdrawn from 

the list if the Agency withdraws or 

suspends approval of the drug’s NDA or 

ANDA for reasons of safety or 

effectiveness, or if FDA determines that 

the listed drug was withdrawn from sale 

for reasons of safety or effectiveness (21 

CFR 314.162). 

Under § 314.161(a) (21 CFR 

314.161(a)), the Agency must determine 

whether a listed drug was withdrawn 

from sale for reasons of safety or 

effectiveness: (1) Before an ANDA that 

refers to that listed drug may be 

approved; (2) whenever a listed drug is 

voluntarily withdrawn from sale and 

ANDAs that refer to the listed drug have 

been approved; and (3) when a person 

petitions for such a determination under 

21 CFR 10.25(a) and 10.30. Section 

314.161(d) provides that if FDA 

determines that a listed drug was 

withdrawn from sale for reasons of 

safety or effectiveness, the Agency will 

initiate proceedings that could result in 

the withdrawal of approval of the 

ANDAs that refer to the listed drug. 

FDA has become aware that the drug 

products listed in the table in this 

document are no longer being marketed. 

(As requested by the applicants, FDA 

withdrew approval of NDA 18–101 for 

SYMMETREL (amantadine 

hydrochloride (HCl)) Tablets and ANDA 

84–935 for DEXEDRINE 

(dextroamphetamine sulfate) Tablets in 

the Federal Register of July 21, 2010 (75 

FR 42455).) 

Application No. Drug Applicant 

NDA 16–979 .............. MEGACE (megestrol acetate) Tablets, 20 milligrams (mg) 

and 40 mg.

Bristol Myers Squibb, P.O. Box 4000, Princeton, NJ 

08543–4000. 

NDA 17–911 .............. CLINORIL (sulindac) Tablet, 150 mg ................................... Merck Research Laboratories, Sumneytown Pike, West 

Point, PA 19486. 

NDA 18–101 .............. SYMMETREL (amantadine HCl) Tablet, 100 mg ................ Endo Pharmaceuticals, Inc., 100 Endo Blvd., Chadds 

Ford, PA 19317. 

NDA 18–482 .............. PROCARDIA (nifedipine) Capsule, 20 mg .......................... Pfizer Inc., 235 East 42nd St., New York, NY 10017–5755. 

NDA 18–768 .............. VEPESID (etoposide) Injection, 20 mg/milliliter (mL) .......... Bristol Myers Squibb. 

NDA 20–262 .............. TAXOL (paclitaxel) Injection, 6 mg/mL ................................ Do. 

NDA 20–450 .............. CEREBYX (fosphenytoin sodium) Injection, Equivalent to 

(EQ) 50 mg phenytoin sodium/mL.

Parke Davis, 2800 Plymouth Rd., Ann Arbor, MI 48106– 

1047. 

NDA 50–527 .............. DURICEF (cefadroxil/cefadroxil hemihydrate) Oral Suspension, EQ 250 mg base/5mL and EQ 500 mg base/5 mL.Warner Chilcott, Inc., 100 Enterprise Dr., Suite 280, Rockaway, NJ 07866. 

ANDA 84–051 ............ DEXTROSTAT (dextroamphetamine sulfate) Tablets, 5 mg 

and 10 mg.

Shire Development, Inc., 725 Chesterbrook Blvd., Wayne, 

PA 19087. 


emcdonald on DSK2BSOYB1PROD with NOTICES