Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is withdrawing approval of 13 new drug applications (NDAs) from multiple holders of these applications. The basis for the withdrawals is that the holders of the applications have repeatedly failed to file required annual reports for the applications.
Effective September 21, 2005.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041.End Further Info End Preamble Start Supplemental 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 § 314.81 (21 CFR 314.81). In the Federal Register of January 28, 2005 (70 FR 4134), FDA published a notice offering an opportunity for a hearing (NOOH) on a proposal to withdraw approval of 13 NDAs because the firms had failed to submit the required annual reports for these applications. On April 28, 2005, the agency withdrew that notice (70 FR 22054) and reissued the corrected NOOH (70 FR 22052). FDA received two responses to the NOOH:
1. The Kendall Co. (Kendall), 15 Hampshire St., Mansfield, MA 02048, notified the agency that they no longer market the following products: NDA 10-337, Fling Antiperspirant Foot Powder; NDA 10-823, BIKE Foot and Body Powder; and NDA 10-824, BIKE Anti-Fungal Aerosol Spray. Kendall informed FDA that their historical files show they sold their rights to these three products (including the licenses) many years ago; however, they did not notify the agency of the sale. Because Kendall sold the products many years ago, they have no record of the new application holder. Neither The Kendall Co. nor the new license holder requested a hearing.
2. Bayer HealthCare LLC, Biological Products Division, 800 Dwight Way, Berkeley, CA 94701-1966, notified the agency that NDA 10-541, BY-NA-MID (Butylphenamide or B and Zinc Oxide or Stearate) Tincture, Ointment, Lotion, and Powder, is not a product produced at their Berkeley site, and that they would forward the NOOH to Bayer HealthCare LLC, Pharmaceutical Division, 400 Morgan Lane, West Haven, CT 06516-4175. Bayer HealthCare LLC in West Haven, CT, informed the agency that NDA 10-541, BY-NA-MID, is not their product and that they have no regulatory files for this product. Bayer HealthCare LLC did not request a hearing.
No other firms responded to the NOOH. Failure to file a written notice of participation and request for hearing as required by § 314.200 (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 13 applications listed in the table of this document.
|NDA 0-763||Sterile Solution Procaine Injection 2% (Procaine Hydrochloride (HCl))||High Chemical Co., 1760 N. Howard St., Philadelphia, PA 19122|
|NDA 2-959||Nicotinic Acid (Niacin) Tablets||The Blue Line Chemical Co., 302 South Broadway, St. Louis, MO 63102|
|NDA 4-236||Sherman (thiamine HCl) Elixir||Do.|
|NDA 4-368||Ascorbic Acid Tablets||Do.|
|NDA 5-159||D.S.D. (diethylstilbestrol dipropionate)||Do.|
|NDA 9-452||Multifuge (piperazine citrate) Syrup||Do.|
|NDA 10-055||Fire Gard Three-Alarm Burn Relief (Methylcellulose)||Gard Products, Inc., 2560 Tara Lane, Brunswick, GA 31520|
|NDA 10-337||Fling Antiperspirant Foot Powder||Bauer & Black, A Division of The Kendall Co., One Federal St., Boston, MA 02110|
|NDA 10-541||BY-NA-MID (Butylphenamide or B and Zinc Oxide or Stearate) Tincture, Ointment, Lotion, and Powder||Miles Inc., Cutter Biological, P.O. Box 1986, Berkeley, CA 94701|
|NDA 10-823||BIKE Foot and Body Powder||Bauer & Black, A Division of The Kendall Co.|
|NDA 10-824||BIKE Anti-Fungal Aerosol Spray||Do.|
|NDA 11-233||TKO with Entrin Roll-On Liquid||Modern-Labs, Inc., Maple Rd., Gambrills, MD 21504|
|NDA 19-432||Spectamine (Iofetamine Hydrochloride I-123) Injection||IMP Inc., 8050 El Rio, Houston, TX 77054|
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 delegated by the Commissioner of Food and Drugs, finds that the holders of the applications Start Printed Page 55405listed in this document have repeatedly failed to submit reports required by § 314.81. In addition, under § 314.200, we find that the holders of the applications have waived any contentions concerning the legal status of the drug products. Therefore, under these findings, approval of the applications listed in this document, and all amendments and supplements thereto, is hereby withdrawn, effective September 21, 2005.Start Signature
Dated: August 29, 2005.
Director, Center for Drug Evaluation and Research.
[FR Doc. 05-18873 Filed 9-20-05; 8:45 am]
BILLING CODE 4160-01-S