[Federal Register Volume 60, Number 10 (Tuesday, January 17, 1995)]
[Notices]
[Pages 3404-3405]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-1074]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

[Docket No. 94N-0304]


Sandoz Pharmaceuticals Corp.; Bromocriptine Mesylate (Parlodel); 
Withdrawal of Approval of the Indication for the Prevention of 
Physiological Lactation

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is withdrawing 
approval of those parts of the new drug application (NDA) 17-962, for 
Parlodel (bromocriptine mesylate) that pertain to the prevention of 
physiological lactation. NDA 17-962 is held by Sandoz Pharmaceuticals 
Corp., 59 Route 10, East Hanover, NJ 07936 (Sandoz). The basis for the 
action is a reevaluation finding that bromocriptine is not shown to be 
safe for use in the prevention of physiological lactation. Sandoz has 
waived its opportunity for a hearing. No other party has requested a 
hearing within the 30 days after the date of publication of the notice 
in the Federal Register of August 23, 1994.

EFFECTIVE DATE: February 16, 1995.
FOR FURTHER INFORMATION CONTACT: Harry Schiller, Center for Drug 
Evaluation and Research (HFD-366), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-2041.

SUPPLEMENTARY INFORMATION:  In a notice published in the Federal 
Register of August 23, 1994 (59 FR 43347), the Director of the Center 
for Drug Evaluation and Research (the Director) offered an opportunity 
for a hearing on a proposal to issue an order under section 505(e) of 
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(e)) 
to withdraw approval of Parlodel's approved indication pertaining to 
the prevention of postpartum physiological lactation. The basis for the 
proposed action was a reevaluation finding that bromocriptine is no 
longer shown to be safe for this indication. Interested parties were 
given 30 days to give a request for an opportunity for a hearing. 
Subsequently, Sandoz, the holder of NDA 17-962, in a letter dated 
August 23, 1994, waived its opportunity for a hearing. No other party 
has filed a request for a hearing within the 30 days after the date of 
publication of the notice in Federal Register of August 23, 1994.
    Accordingly, for the reasons discussed in the August 23, 1994, 
notice, the Director, under section 505(e) of the act, and under 
authority [[Page 3405]] delegated to her (21 CFR 5.82), finds that new 
evidence of clinical experience not contained in the application and 
not available until after the supplement to the application for the 
indication was approved, evaluated together with the evidence available 
when the supplement to the application for the indication was approved, 
shows that bromocriptine is not shown to be safe for the prevention of 
physiological lactation upon the basis of which the indication was 
approved (21 U.S.C. 355(e)(2)).
    Therefore, pursuant to the foregoing finding, approval of the 
indication is hereby withdrawn, effective February 16, 1995.

    Dated: December 27, 1994.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 95-1074 Filed 1-13-95; 8:45 am]
BILLING CODE 4160-01-F