[Federal Register Volume 63, Number 209 (Thursday, October 29, 1998)]
[Notices]
[Page 58053]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-29049]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket Nos. 98N-0718 and 76N-0377; DESI 7661]


Eli Lilly & Co. and Bristol-Myers Squibb Co.; Withdrawal of 
Approval of Three New Drug Applications for Estrogen-Androgen 
Combination Drugs

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of three new drug applications (NDA's) for estrogen-androgen 
combination drugs. The NDA's are held by Eli Lilly & Co. and Bristol-
Myers Squibb Co. The products are no longer marketed. Both companies 
requested that the NDA's be withdrawn and waived their opportunity for 
a hearing. The products will be removed from the list of drug products 
with effective approvals.

EFFECTIVE DATE: October 29, 1998.
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: Previous Federal Register notices regarding 
the regulatory status of the three applications named below, as well as 
two others (NDA's 10-597 and 11-267), were published on September 8, 
1972 (37 FR 18225), and September 29, 1976 (41 FR 43112). (The 
approvals of NDA 10-597 (Tace with Androgen Capsules containing 
chlorotrianisone and methyltestosterone) and NDA 11-267 (Halodrin 
Tablets containing fluoxymesterone and ethinyl estradiol) were 
withdrawn in Federal Register notices of June 25, 1993 (58 FR 34466), 
and March 2, 1994 (59 FR 9989), respectively; see also 43 FR 49564 
(October 24, 1978), which was a proposal to withdraw approval of 
estrogen-containing drug products labeled for use in postpartum breast 
engorgement.)
    By letter dated June 5, 1998, Bristol-Myers Squibb Co., P.O. Box 
4000, Princeton, NJ 08543, requested that FDA withdraw approval of NDA 
9-545 (Deladumone OB Injection and Deladumone Injection, each 
containing testosterone enanthate and estradiol valerate), stating that 
the marketing of Deladumone OB Injection was discontinued in 1989 when 
the indication for postpartum breast engorgement was withdrawn (noting 
that this was the only indication for Deladumone OB Injection), and 
that the marketing of Deladumone Injection was discontinued in 1991 
because there was no longer a significant patient population requiring 
the concurrent therapy of an estrogen and an androgen in a fixed dose.
    By letters dated July 15, 1998, and July 30, 1998, Eli Lilly & Co., 
Lilly Corporate Center, Indianapolis, IN 46285, requested that FDA 
withdraw approval of NDA 7-661 (Tylosterone Tablets) and NDA 8-099 
(Tylosterone Injection), both containing diethylstylbestrol and 
methyltestosterone, stating that the marketing of both products was 
discontinued in 1988 because there was no longer a significant patient 
population requiring the concurrent therapy of an estrogen and an 
androgen in a fixed dose.
    Both applicants waived their opportunity for a hearing. The agency 
concurs in the applicants' finding that there is not a significant 
patient population requiring the concurrent therapy of an estrogen and 
an androgen in a fixed dose.
    Approval of a new drug application will be withdrawn if there is a 
lack of substantial evidence that the drug product covered by the 
application has the clinical effect that it purports or is represented 
to have under the conditions of use prescribed, recommended, or 
suggested in its labeling (21 U.S.C. 355(e)). For fixed combination 
prescription drugs, such substantial evidence exists only if each 
component makes a contribution to the claimed effects and the dosage of 
each component (amount, frequency, duration) is such that the 
combination is safe and effective for a significant patient population 
requiring such concurrent therapy, as defined in the labeling for the 
drug (21 CFR 300.50). Estrogen and androgen fixed-dose combination 
products, therefore, lack substantial evidence of effectiveness due to 
the fact that there is not a significant patient population requiring 
the concurrent therapy of an estrogen and an androgen in a fixed dose.
    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 5.70 and 
5.82), approval of NDA's 7-661, 8-099, and 9-545 and all amendments and 
supplements thereto, is hereby withdrawn for the reasons stated above, 
effective October 29, 1998.. Under 21 CFR 314.161 and 314.162(a)(1), 
four of the estrogen and androgen fixed-dose combination products named 
above (NDA's 7-661, 8-099, 9-545, and 11-267) will be removed from the 
list of drug products with effective approvals published in FDA's 
publication, ``Approved Drug Products with Therapeutic Equivalence 
Evaluations.'' FDA will not approve or accept ANDA's that refer to 
these drug products.

    Dated: October 22, 1998.
 Janet Woodcock,
 Director, Center for Drug Evaluation and Research.
[FR Doc. 98-29049 Filed 10-28-98; 8:45 am]
BILLING CODE 4160-01-F