[Federal Register Volume 66, Number 186 (Tuesday, September 25, 2001)]
[Notices]
[Pages 49030-49031]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-23979]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0418]


Solvay Pharmaceuticals, Inc.; Withdrawal of Approval of Two 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 two new drug applications (NDAs) held by Solvay Pharmaceuticals, 
Inc., 901 Sawyer Rd., Marietta, GA 30062. In 1997, the agency informed 
Solvay of its intention to assess the validity of data and information 
in all of Solvay's pending and approved applications. However, Solvay 
does not intend to conduct validity assessments of the two NDAs named 
in this notice because the products are no longer marketed. Solvay has 
agreed to permit FDA to withdraw approval of the applications, thereby 
waiving its opportunity for a hearing.

DATES: Effective September 25, 2001.

FOR FURTHER INFORMATION CONTACT: David Read, Center for Drug Evaluation 
and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION: Recently, FDA determined that Solvay 
submitted untrue statements of material fact in several applications 
filed with the agency. These findings, along with other information 
submitted to the agency by Solvay, provided sufficient justification to 
question the reliability of data in all of Solvay's applications filed 
with the agency. Solvay was notified in writing of the agency's 
determinations and its intention to assess the validity of the data and 
information in all of Solvay's pending and approved applications. The 
agency offered Solvay the opportunity to permit FDA to withdraw 
approval, under Sec. 314.150(d) (21 CFR 314.150(d)), of any application 
not undergoing a validity assessment.
    Subsequently, in letters dated February 29, 2000, Solvay requested 
withdrawal under Sec. 314.150(d) of the following NDAs held by Solvay:
    NDA 16-782; Lithonate (lithium carbonate tablets USP) 300 
milligrams (mg); and
    NDA 16-980; Lithotabs (lithium carbonate tablets USP) 300 mg.
    Therefore, under section 505(e) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(e)) and under authority

[[Page 49031]]

delegated to the Director of the Center for Drug Evaluation and 
Research (21 CFR 5.82), approval of the NDAs listed above, and all 
amendments and supplements thereto, is withdrawn effective September 
25, 2001. Distribution of these products in interstate commerce without 
an approved application is illegal and subject to regulatory action.

    Dated: September 17, 2001.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 01-23979 Filed 9-24-01; 8:45 am]
BILLING CODE 4160-01-S