Federal Register / Vol. 82, No. 171 / Wednesday, September 6, 2017 / Notices 42101 

1 GYNOREST was marketed in the United States 

under a supplement to NDA 012985 for 

DUPHASTON (dydrogesterone, oral tablets). 

Distribution of GYNOREST under the 

DUPHASTON NDA discontinued around 1981. 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–P–2675] 

Determination That GYNOREST 

(Dydrogesterone) Oral Tablets, 5 

Milligrams and 10 Milligrams, 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Withdrawn From Sale for Reasons of 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 or Agency) has 

determined that GYNOREST 

(dydrogesterone) oral tablets, 5 

milligrams (mg) and 10 mg, were not 

withdrawn from sale for reasons of 

safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for GYNOREST 

(dydrogesterone) oral tablets, 5 mg and 

10 mg, if all other legal and regulatory 

requirements are met. 

FOR FURTHER INFORMATION CONTACT: 

Stefanie Kraus, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6214, 

Silver Spring, MD 20993–0002, 301– 

796–9585. 

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 

approving 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. 

GYNOREST (dydrogesterone) oral 

tablets, 5 mg and 10 mg, are the subject 

of NDA 017388, held by Solvay 

Pharmaceuticals (Solvay), and initially 

approved on October 31, 1978. 

GYNOREST is indicated for amenorrhea 

and abnormal uterine bleeding due to 

hormonal imbalance in the absence of 

organic pathology, such as submucous 

fibroids or uterine cancer. 

Solvay never marketed GYNOREST 

(dydrogesterone) oral tablets, 5 mg and 

10 mg, under NDA 017388.1 In previous 

instances (see e.g., 72 FR 9763, March 

5, 2007, and 61 FR 25497, May 21, 

1996), the Agency has determined that, 

for purposes of §§ 314.61 and 314.162, 

never marketing an approved drug 

product is equivalent to withdrawing 

the drug from sale. In a letter dated June 

1, 1992, Solvay requested withdrawal of 

NDA 017388 for GYNOREST 

(dydrogesterone) oral tablets, 5 mg and 

10 mg. In the Federal Register of June 

25, 1993 (58 FR 34466), FDA announced 

that it was withdrawing approval of 

NDA 017388, effective July 26, 1993. 

Foley and Lardner LLP submitted a 

citizen petition dated September 7, 2016 

(Docket No. FDA–2016–P–2675), under 

21 CFR 10.30, requesting that the 

Agency determine whether GYNOREST 

(dydrogesterone) oral tablets, 5 mg and 

10 mg, were 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 GYNOREST 

(dydrogesterone) oral tablets, 5 mg and 

10 mg, were not withdrawn for reasons 

of safety or effectiveness. The petitioner 

states that GYNOREST (dydrogesterone) 

oral tablets, 5 mg and 10 mg, were not 

withdrawn for reasons of safety and 

effectiveness because the active 

pharmaceutical ingredient 

dydrogesterone and the drug product 

dydrogesterone tablets have a 

monograph in the current United States 

Pharmacopeia, public information 

indicates that Solvay discontinued the 

product for commercial reasons, there 

has been no notice in the Federal 

Register reflecting an Agency 

determination that the product was 

withdrawn for reasons of safety or 

effectiveness, and dydrogesterone oral 

tablets are being sold in many other 

countries. 

We have carefully reviewed our files 

for records concerning the withdrawal 

of GYNOREST (dydrogesterone) oral 

tablets, 5 mg and 10 mg, from sale. We 

have also independently evaluated 

relevant literature and data for possible 

post-marketing 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 GYNOREST 

(dydrogesterone) oral tablets, 5 mg and 

10 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 GYNOREST 

(dydrogesterone) oral tablets, 5 mg and 

10 mg, 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: August 28, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–18816 Filed 9–5–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–D–4852] 

Design Considerations and Premarket 

Submission Recommendations for 

Interoperable Medical Devices; 

Guidance for Industry and Food and 

Drug Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 


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