[Federal Register Volume 63, Number 108 (Friday, June 5, 1998)]
[Notices]
[Page 30765]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-14914]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95N-0182]
KV Pharmaceutical Co.; Withdrawal of Approval of Two Abbreviated
New Drug Applications and One Abbreviated Antibiotic Application
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of two abbreviated new drug applications (ANDA's) and one abbreviated
antibiotic drug application (AADA) held by KV Pharmaceutical Co. (KV),
2503 South Hanley Rd., St. Louis, MO 63144. This action is being taken
because the applications contain untrue statements of material fact,
and the drugs covered by these applications lack substantial evidence
of effectiveness.
EFFECTIVE DATE: June 5, 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: In the Federal Register of June 26, 1995 (60
FR 32982), FDA published a notice offering an opportunity for a hearing
(NOOH) on a proposal to withdraw approval of the following abbreviated
applications:
AADA 62-047, Erythromycin Ethylsuccinate Oral Suspension, 200 and
400 milligrams (mg);
ANDA 71-929, Disopyramide Phosphate Extended Release Capsules, 100
mg; and
ANDA 86-538, Nitroglycerin Extended Release Capsules, 2.5 mg.
The grounds for the proposed withdrawals were: (1) That the
applications contained untrue statements of material fact, and (2) that
based upon new information evaluated together with the evidence
available when the applications were approved, there is a lack of
substantial evidence that the drugs will have the effect they purport
or are represented to have under the conditions of use prescribed,
recommended, or suggested in their labeling.
On July 26, 1995, KV requested a hearing. Subsequently, in a letter
dated August 25, 1995, KV withdrew its request for a hearing and
requested withdrawal of these applications because the products are no
longer being marketed. (AADA 62-047 was inadvertently included in a
previous Federal Register notice (61 FR 13506, March 27, 1996) that
withdrew a large number of applications based on the request of the
applicants.)
Based on the information presented in the June 26, 1995, notice,
the Director of the Center for Drug Evaluation and Research, under
section 505(e) of the Federal Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 355(e)) and under authority delegated to her (21 CFR 5.82),
finds that the applications listed above contain untrue statements of
material fact (21 U.S.C. 355(e)(5)); and that on the basis of new
information before her with respect to the drugs, evaluated together
with the evidence available to her when the applications were approved,
there is a lack of substantial evidence that the drugs will have the
effects they purport or are represented to have under the conditions of
use prescribed, recommended, or suggested in their labeling (21 U.S.C.
355(e)(3)).
Therefore, approval of the applications listed above, and all their
amendments and supplements, is hereby withdrawn, effective June 5,
1998. Distribution of these products in interstate commerce without an
approved application is illegal and subject to regulatory action.
Section 505(j)(7)(C) of the act requires that FDA immediately
remove from its approved product list (``Approved Drug Products with
Therapeutic Equivalence Evaluation'') (``the list'') any drug whose
approval was withdrawn for grounds described in the first sentence of
section 505(e) of the act. Such grounds apply to this withdrawal.
Notice is hereby given that the drugs covered by these applications are
removed from the list.
Dated: May 28, 1998.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 98-14914 Filed 6-4-98; 8:45 am]
BILLING CODE 4160-01-F