Human drugs: New drug applications— High Chemical Co., et al. approval withdrawn,

[Federal Register: September 21, 2005 (Volume 70, Number 182)]

[Notices]

[Page 55404-55405]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr21se05-91]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0143]

High Chemical Co. et al.; Withdrawal of Approval of 13 New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

SUMMARY: 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.

DATES: Effective September 21, 2005.

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.

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). 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 Sec. 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.

Application No.

Drug

Applicant

NDA 0-763

Sterile Solution

High Chemical Co., 1760 Procaine Injection 2% N. Howard St., (Procaine

Philadelphia, PA 19122 Hydrochloride (HCl))

NDA 2-959

Nicotinic Acid (Niacin) The Blue Line Chemical Tablets

Co., 302 South Broadway, St. Louis, MO 63102

NDA 4-236

Sherman (thiamine HCl) Do. Elixir

NDA 4-368

Ascorbic Acid Tablets Do.

NDA 5-159

D.S.D.

Do. (diethylstilbestrol dipropionate)

NDA 9-452

Multifuge (piperazine Do. citrate) Syrup

NDA 10-055

Fire Gard Three-Alarm Gard Products, Inc., Burn Relief

2560 Tara Lane, (Methylcellulose)

Brunswick, GA 31520

NDA 10-337

Fling Antiperspirant Bauer & Black, A Foot Powder

Division of The Kendall Co., One Federal St., Boston, MA 02110

NDA 10-541

BY-NA-MID

Miles Inc., Cutter (Butylphenamide or B Biological, P.O. Box and Zinc Oxide or

1986, Berkeley, CA Stearate) Tincture, 94701 Ointment, Lotion, and Powder

NDA 10-823

BIKE Foot and Body Bauer & Black, A Powder

Division of The Kendall Co.

NDA 10-824

BIKE Anti-Fungal

Do. Aerosol Spray

NDA 11-233

TKO with Entrin Roll-On Modern-Labs, Inc., Liquid

Maple Rd., Gambrills, MD 21504

NDA 19-432

Spectamine (Iofetamine IMP Inc., 8050 El Rio, Hydrochloride I-123) Houston, TX 77054 Injection

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

[[Page 55405]]

listed in this document have repeatedly failed to submit reports required by Sec. 314.81. In addition, under Sec. 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.

Dated: August 29, 2005. Steven Galson, Director, Center for Drug Evaluation and Research.

[FR Doc. 05-18873 Filed 9-20-05; 8:45 am]

BILLING CODE 4160-01-S