[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]


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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.

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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requested that the approval of the applications be withdrawn.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