[Federal Register Volume 64, Number 56 (Wednesday, March 24, 1999)]
[Notices]
[Pages 14252-14253]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-7124]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-1036]
Vale Chemical Co., Inc., et al.; Withdrawal of Approval of 13 New
Drug Applications and 1 Abbreviated New Drug Application
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 13 new drug applications (NDA's) and 1 abbreviated new drug
application (ANDA). The basis for the withdrawals is that the holders
of the applications have repeatedly failed to file required annual
reports for these applications.
EFFECTIVE DATE: March 24, 1999.
FOR FURTHER INFORMATION CONTACT: Olivia A. Pritzlaff, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2041.
SUPPLEMENTARY INFORMATION: The holders of approved applications to
market new drugs or antibiotics for human use are required to submit
annual reports to FDA concerning each of their approved applications in
accordance with Sec. 314.81 (21 CFR 314.81).
In the Federal Register of December 2, 1998 (63 FR 66549), FDA
offered an opportunity for a hearing on a proposal to withdraw approval
of 13 NDA's and 1 ANDA because the firms had failed to submit the
required annual reports for these applications.
Wyeth-Ayerst Laboratories, P.O. Box 8299, Philadelphia, PA 19101-
8299, notified the agency that they no longer market the products for
NDA's 50-088, 50-129, 50-189, 50-197, 50-305, and 50-319. Wyeth-Ayerst
did not request a hearing and submitted a formal request for the agency
to withdraw approval of the NDA's for these products.
The holders of the other eight applications did not respond to the
notice of opportunity for a hearing. Failure to file a written notice
of participation and request for a hearing as required by 21 CFR
314.200 constitutes an election by the applicant not to make use of the
opportunity for a hearing concerning the proposal to withdraw approval
of the applications and a waiver of any contentions concerning the
legal status of the drug products. Therefore, the Director, Center for
Drug Evaluation and Research, is withdrawing approval of the
applications listed in the table of this document.
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Application No. Drug Applicant
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NDA 7-112 Nisaval (pyrilamine maleate) 25 milligram Vale Chemical Co., Inc., 1201 Liberty St.,
(mg) Tablets Allentown, PA 18102.
NDA 11-863 Flavihist Cough Syrup Boyle & Co., 6330 Chalet Dr., Los Angeles,
CA 90022.
NDA 50-042 Potassium Penicillin G Diagnostic Pfizer Inc., 235 East 42d St., New York, NY
Sensitivity Powder, 20,000 units 10017-5755.
NDA 50-067 Compocillin-VK Chewable Wafers Abbott Laboratories, 100 Abbott Park Rd.,
Abbott Park, IL 60064.
NDA 50-088 Unipen Injection Wyeth-Ayerst Laboratories, P.O. Box 8299,
Philadelphia, PA 19101-8299.
NDA 50-121 Compocillin-VK Tablets Abbott Laboratories.
NDA 50-122 Compocillin-V Chewable Wafers Do.
NDA 50-129 Pen-Vee Suspension and Drops Wyeth-Ayerst Laboratories.
NDA 50-189 Omnipen Tablets Do.
NDA 50-197 Unipen Injection Do.
NDA 50-305 Unipen Capsules Do.
NDA 50-319 Omnipen Chewable Tablets Do.
NDA 50-413 Geopen Diagnostic Susceptibility Powder Pfizer Inc.
ANDA 87-387 Aminophylline Injection USP, 25 mg/ Pharma-Serve, Inc., 218-20 98th Ave.,
milliliter Queens Village, NY 11429.
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The Director, Center for Drug Evaluation and Research, under
section 505(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(e)), and under authority of 21 CFR 5.82, finds that the holders of
the applications listed in the table of this document have repeatedly
failed to submit reports required by Sec. 314.81. Therefore, under
[[Page 14253]]
this finding, approval of the applications listed in the table of this
document, and all amendments and supplements thereto, is hereby
withdrawn, effective March 24, 1999.
Dated: March 8, 1999.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 99-7124 Filed 3-23-99; 8:45 am]
BILLING CODE 4160-01-F
