[Federal Register Volume 61, Number 99 (Tuesday, May 21, 1996)]
[Notices]
[Pages 25498-25499]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-12760]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 93P-0322]


Determination that Medroxyprogesterone Acetate 100 Milligrams per 
Milliliter Was Not Withdrawn From Sale for Reasons of Safety or 
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY:  The Food and Drug Administration (FDA) has determined that 
medroxyprogesterone acetate (Depo-Provera) 100 milligrams per 
milliliter (mg/mL) was not withdrawn from sale for reasons of safety or 
effectiveness. This determination will allow sponsors to submit 
abbreviated new drug applications (ANDA's) for medroxyprogesterone 
acetate 100 mg/mL.

FOR FURTHER INFORMATION CONTACT: Wayne H. Mitchell, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1049.

SUPPLEMENTARY INFORMATION: In 1984, Congress passed into law 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 
sponsors 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 under a new drug application 
(NDA). Sponsors of ANDA's do not have to repeat the extensive clinical 
testing otherwise necessary to gain approval of an 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 included what is now section 505(j)(6) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(6)), 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 Under FDA regulations, drugs are withdrawn from the list if the 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 (Sec. 314.162 (21 CFR 314.162)). Regulations also provide 
that the agency must make a determination as to 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 
(Sec. 314.161(a)(1) (21 CFR 314.161(a)(1))). FDA may not approve an 
ANDA that does not refer to a listed drug.
    -On August 30, 1993, King & Spalding submitted a citizen petition 
(Docket No. 93P-0322/CP1) under 21 CFR 10.25(a) and 10.30 requesting 
that the agency determine whether medroxyprogesterone acetate 100 mg/mL 
was withdrawn from sale for reasons of safety or effectiveness and, if 
the agency determines that the drug was not withdrawn from sale for 
reasons of safety or effectiveness, to keep the drug in the ``Approved 
Drug Products with Therapeutic Equivalence Evaluations.'' 
Medroxyprogesterone acetate 100 mg/mL, along with the 400 mg/mL 
strength, is the subject of approved NDA 12-541 held by the Upjohn Co. 
(Upjohn). On December 1, 1992, Upjohn withdrew medroxyprogesterone 
acetate 100 mg/mL from sale.
    -FDA has reviewed its records and, under Secs. 314.161 and 
314.162(c), has determined that medroxyprogesterone acetate 100 mg/mL 
was not withdrawn from sale for reasons of safety or effectiveness and 
will continue to list medroxyprogesterone acetate 100 mg/mL in the 
``Discontinued Drug Product List'' contained in the ``Approved Drug 
Products with Therapeutic Equivalence Evaluations.'' The ``Discontinued 
Drug Product List'' lists, among other items, drug products that have 
been discontinued from marketing for reasons other than safety or 
effectiveness. ANDA's that refer to medroxyprogesterone acetate 100 mg/
mL may be submitted to the agency.
    -FDA has also considered the comment submitted by Upjohn, dated 
November 19, 1993, opposing an FDA determination that 
medroxyprogesterone acetate 100 mg/mL was withdrawn from the market for 
reasons other than safety or effectiveness. The comment does not 
contain any information indicating that the drug was withdrawn for 
reasons of safety or effectiveness, but rather indicates that Upjohn 
did not perceive a need to keep medroxyprogesterone

[[Page 25499]]

acetate in a 100 mg/mL strength on the market because the 400 mg/mL 
strength, which Upjohn also marketed, was viewed as a more convenient 
strength for the approved indication of adjunctive therapy and 
palliative treatment of inoperable recurrent and metastatic endometrial 
or renal carcinoma.

    Dated: May 15, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-12760 Filed 5-21-96; 8:45 am]
BILLING CODE 4160-01-F