49380 Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–P–0840] 

Determination That OVRETTE 

(Norgestrel) Tablet, 0.075 Milligrams, 

Was Not Withdrawn From Sale for 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 or Agency) has 

determined that OVRETTE (norgestrel) 

tablet, 0.075 milligrams (mg), was not 

withdrawn from sale for reasons of 

safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for norgestrel 

tablet, 0.075 mg, if all other legal and 

regulatory requirements are met. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gottlieb, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6217, 

Silver Spring, MD 20993–0002, 301– 

796–6650. 

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 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 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 known generally as the 

‘‘Orange Book.’’ Under FDA regulations, 

drugs are 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was withdrawn from sale for reasons of 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). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

FDA’s approval of an ANDA that refers 

to the listed drug (§ 314.161 (21 CFR 

314.161)). FDA may not approve an 

ANDA that does not refer to a listed 

drug. 

OVRETTE (norgestrel) tablet, 0.075 

mg, is the subject of NDA 017031, held 

by HRA Pharma and initially approved 

on October 23, 1973. OVRETTE is 

indicated for the prevention of 

pregnancy in women. 

OVRETTE (norgestrel) tablet, 0.075 

mg, was discontinued from U.S. 

distribution on June 7, 2005, and is 

currently listed in the ‘‘Discontinued 

Drug Product List’’ section of the Orange 

Book. 

The Weinberg Group submitted a 

citizen petition dated February 8, 2017 

(Docket No. FDA–2017–P–0840), under 

21 CFR 10.30, requesting that the 

Agency determine whether OVRETTE 

(norgestrel) tablet, 0.075 mg, was 

withdrawn from sale for reasons of 

safety or effectiveness. 

After considering the citizen petition 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that OVRETTE (norgestrel) 

tablet, 0.075 mg, was not withdrawn 

from sale for reasons of safety or 

effectiveness. The petitioner has 

identified no data or other information 

suggesting that OVRETTE (norgestrel) 

tablet, 0.075 mg, was withdrawn for 

reasons of safety or effectiveness. We 

have carefully reviewed our files for 

records concerning the withdrawal of 

OVRETTE (norgestrel) tablet, 0.075 mg, 

from sale. We have also independently 

evaluated relevant literature and data 

for possible postmarketing adverse 

events. We have found no information 

that would indicate that this drug 

product was withdrawn from sale for 

reasons of safety or effectiveness. 

Accordingly, the Agency will 

continue to list OVRETTE (norgestrel) 

tablet, 0.075 mg, 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 this drug product 

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: October 17, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–23125 Filed 10–24–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0656] 

Animal Drug User Fee Act; 

Recommendations; Request for 

Comments; Extension of Comment 

Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability; request 

for comments; extension of comment 

period. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the availability of the 

Animal Drug User Fee Act (ADUFA) 

reauthorization draft recommendations 

and extending the comment period to 

allow interested persons 30 days to 

submit comments on these draft 

recommendations. 

DATES: FDA is extending the comment 

period on the ADUFA reauthorization 

and draft recommendations. Submit 

either electronic or written comments 

on the draft recommendations by 

November 24, 2017. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before November 24, 

2017. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end November 24, 2017. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 


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