[Federal Register: December 2, 1998 (Volume 63, Number 231)] [Notices] [Page 66549-66550] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr02de98-66] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 98N-1036] Vale Chemical Co., Inc., et al.; Proposal to Withdraw Approval of 13 New Drug Applications and 1 Abbreviated New Drug Application; Opportunity for a Hearing AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for a hearing on the agency's proposal to withdraw approval of 13 new drug applications (NDA's) and 1 abbreviated new drug application (ANDA). The basis for the proposal is that the sponsors have repeatedly failed to file required annual reports for these applications. DATES: Written requests for a hearing are due by January 4, 1999; data and information in support of the hearing request are due by February 1, 1999. ADDRESSES: Requests for a hearing, supporting data, and other comments should be identified with Docket No. 98N-1036 and submitted to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 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 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). The holders of the applications listed in the following table have failed to submit the required [[Page 66550]] annual reports and have not responded to the agency's request by certified mail for submission of the reports. ---------------------------------------------------------------------------------------------------------------- Application No. Drug Applicant ---------------------------------------------------------------------------------------------------------------- NDA 7-112.......................... Nisaval (pyrilamine maleate) 25 Vale Chemical Co., Inc., 1201 milligram (mg) Tablets. Liberty St., 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 Sensitivity Powder, 20,000 units. York, NY 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 Pfizer Inc. Powder. ANDA 87-387........................ Aminophylline Injection USP,25 mg/ Pharma-Serve, Inc., 218-20 98th milliliter. Ave., Queens Village, NY 11429. ---------------------------------------------------------------------------------------------------------------- Therefore, notice is given to the holders of the applications listed in the table and to all other interested persons that the Director of the Center for Drug Evaluation and Research proposes to issue an order under section 505(e) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(e)) withdrawing approval of the applications and all amendments and supplements thereto on the ground that the applicants have failed to submit reports required under Sec. 314.81. In accordance with section 505 of the act and part 314 (21 CFR part 314), the applicants are hereby provided an opportunity for a hearing to show why the applications listed previously should not be withdrawn and an opportunity to raise, for administrative determination, all issues relating to the legal status of the drug products covered by these applications. An applicant who decides to seek a hearing shall file: (1) On or before January 4, 1999, a written notice of participation and request for a hearing, and (2) on or before February 1, 1999, the data, information, and analyses relied on to demonstrate that there is a genuine and substantial issue of fact that requires a hearing. Any other interested person may also submit comments on this notice. The procedures and requirements governing this notice of opportunity for a hearing, notice of participation, and request for a hearing, information and analyses to justify a hearing, other comments, and a grant or denial of a hearing are contained in Sec. 314.200 and in 21 CFR part 12. The failure of an applicant to file a timely written notice of participation and request for a hearing, as required by Sec. 314.200, constitutes an election by that applicant not to avail itself of the opportunity for a hearing concerning the proposal to withdraw approval of the applications and constitutes a waiver of any contentions concerning the legal status of the drug products. FDA will then withdraw approval of the applications and the drug products may not thereafter lawfully be marketed, and FDA will begin appropriate regulatory action to remove the products from the market. Any new drug product marketed without an approved NDA is subject to regulatory action at any time. A request for a hearing may not rest upon mere allegations or denials, but must present specific facts showing that there is a genuine and substantial issue of fact that requires a hearing. Reports submitted to remedy the deficiencies must be complete in all respects in accordance with Sec. 314.81. If the submission is not complete or if a request for a hearing is not made in the required format or with the required reports, the Commissioner of Food and Drugs will enter summary judgment against the person who requests the hearing, making findings and conclusions, and denying a hearing. All submissions under this notice of opportunity for a hearing must be filed in four copies. Except for data and information prohibited from public disclosure under 21 U.S.C. 331(j) or 18 U.S.C. 1905, the submissions may be seen in the Dockets Management Branch (address above) between 9 a.m. and 4 p.m., Monday through Friday. This notice is issued under the Federal Food, Drug, and Cosmetic Act (sec. 505 (21 U.S.C. 355)) and under authority delegated to the Director, Center for Drug Evaluation and Research (21 CFR 5.82). Dated: November 12, 1998. Janet Woodcock, Director, Center for Drug Evaluation and Research. [FR Doc. 98-32069 Filed 12-1-98; 8:45 am] BILLING CODE 4160-01-F