[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Milliliter Was Not Withdrawn From Sale for Reasons of Safety or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milliliter (mg/mL) was not withdrawn from sale for reasons of safety or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 Under FDA regulations, drugs are withdrawn from the list if the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listed drug was withdrawn from sale for reasons of safety or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
