Vale Chemical Co., Inc., et al.; Withdrawal of Approval of 13 New Drug Applications and 1 Abbreviated New Drug Application

[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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.

 
----------------------------------------------------------------------------------------------------------------
    Application No.                         Drug                                      Applicant
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------

    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