[Federal Register: September 21, 2005 (Volume 70, Number 182)]
[Page 55404-55405]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2005N-0143]

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

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.
NDA 4-368               Ascorbic Acid Tablets    Do.
NDA 5-159               D.S.D.                   Do.
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
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

    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]