[Federal Register Volume 68, Number 71 (Monday, April 14, 2003)]
[Notices]
[Pages 17957-17958]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-9064]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 98N-0718 and 76N-0377]
Pharmacia & Upjohn et al.; Withdrawal of Approval of One New Drug
Application and Four Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of one new drug application (NDA) and four abbreviated new drug
applications (ANDAs). The holders of the applications notified the
agency in writing that the drug products were no longer marketed and
requested that the approval of the applications be withdrawn.
EFFECTIVE DATE: May 14, 2003.
FOR FURTHER INFORMATION CONTACT: David T. Read, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2041.
SUPPLEMENTARY INFORMATION: The holders of the applications listed in
the table in this document have informed FDA that these drug products
are no longer marketed and have requested that FDA withdraw approval of
the applications. The applicants have also, by their requests, waived
their opportunity for a hearing.
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 17-968 Depo-Testadiol Pharmacia & Upjohn
(testosterone Co., 7000 Portage
cypionate and Rd., Kalamazoo, MI
estradiol cypionate) 49001-0199.
Injection, 50
milligrams/milliliter
(mg/mL) and 2 mg/mL.
------------------------------------------------------------------------
ANDA 85-603 Testosterone Cypionate- Steris Laboratories,
Estradiol Cypionate Inc., 620 North 51st
Injection. Ave., Phoenix, AZ
85043-4706.
------------------------------------------------------------------------
ANDA 85-860 Testosterone Enanthate Do.
and Estradiol Valerate
Injection, 180 mg/mL
and 8 mg/mL.
------------------------------------------------------------------------
ANDA 85-865 Testosterone Enanthate Do.
and Estradiol Valerate
Injection, 90 mg/mL
and 4 mg/mL.
------------------------------------------------------------------------
ANDA 86-423 Ditate-DS (testosterone Savage Laboratories,
enanthate and 60 Baylis Rd.,
estradiol valerate) Melville, NY 11747.
Injection, 180 mg/mL
and 8 mg/mL.
------------------------------------------------------------------------
The applications listed in the table in this document, all
estrogen-androgen combination products, were submitted following a
finding by the FDA published in the Federal Register of September 29,
1976 (41 FR 43112). Elsewhere in today's issue of the Federal Register,
FDA is initiating a proceeding in which it proposes to amend the 1976
notice. That proceeding will determine if there is substantial evidence
of effectiveness of the estrogen-androgen combination products
specifically named in the notice proposing to amend the 1976 notice, as
well as of any products that are identical, related, or similar
(including but not limited to the five products listed in this notice).
The agency, therefore, is deferring until the outcome of that
proceeding the determination, under Sec. 314.161 (21 CFR 314.161), of
whether the five products listed in this notice were withdrawn for
reasons of safety or effectiveness.
Therefore, under section 505(e) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(e)) and under authority delegated to the
Director, Center for Drug Evaluation and Research (21 CFR 5.105),
approval of the applications listed in the table in this document, and
all amendments and supplements thereto, is hereby withdrawn, effective
May 14, 2003.
[[Page 17958]]
Dated: April 4, 2003.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 03-9064 Filed 4-10-03; 8:45 am]
BILLING CODE 4160-01-S