[Federal Register: October 29, 1998 (Volume 63, Number 209)]
[Notices]
[Page 58053]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29oc98-85]

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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requested that the NDA's be withdrawn and waived their opportunity for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withdrawn in Federal Register notices of June 25, 1993 (58 FR 34466),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the indication for postpartum breast engorgement was withdrawn (noting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