[Federal Register Volume 61, Number 187 (Wednesday, September 25, 1996)]
[Notices]
[Pages 50323-50324]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-24610]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0075]
Hance Brothers and White Co., et al.; Withdrawal of Approval of
16 Abbreviated Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is withdrawing 3
abbreviated antibiotic applications (AADA'S) and 13 abbreviated new
drug applications (ANDA's). The basis for the withdrawals is that the
sponsors have repeatedly failed to file required annual reports for
these applications.
EFFECTIVE DATE: September 25, 1996.
FOR FURTHER INFORMATION CONTACT: Olivia A. Vieira, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1046.
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 March 15, 1996 (61 FR 10768), FDA
offered an opportunity for a hearing on a proposal to withdraw approval
of 17 abbreviated applications because the firms had failed to submit
the required annual reports for these applications.
One application holder, Superpharm Corp. notified the agency in
writing that ANDA 89-184, Acetaminophen and Codeine Phosphate Tablets,
is no longer marketed and requested that approval of the application be
withdrawn. FDA withdrew approval of ANDA 89-184 in the Federal Register
of August 5, 1996 (61 FR 40649).
The holders of the other 16 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 in this
document.
[[Page 50324]]
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Application no. Drug Applicant
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AADA 60-276..................... Neomycin and Hance Brothers and White Co.
Polymyxin B
Sulfates and
Bacitracin
Ointment.
AADA 60-422..................... Tetracycline Premo Pharmaceutical Laboratories, Inc.
Hydrochloride
Tablets.
AADA 62-362..................... Erythromycin Life Laboratories, Inc.
Estolate
Suspension, 250
milligrams (mg)
per 5 milliliters
(mL).
ANDA 80-126..................... Isoniazid Tablets, Everylife.
300 mg.
ANDA 80-689..................... Cyanocobalamin Dell Laboratories, Inc.
Injection, USP, 30
micrograms (g) per mL, 100
g/mL, and
100 g/mL.
ANDA 83-387..................... Lidocaine Do.
Hydrochloride
Injection, USP, 1%.
ANDA 83-388..................... Lidocaine Do.
Hydrochloride
Injection, USP, 2%.
ANDA 83-665..................... Vitamin A Capsules, Wharton Laboratories.
USP.
ANDA 83-771..................... Pyridoxine Dell Laboratories, Inc.
Hydrochloride
Injection, USP, 50
mg/mL.
ANDA 83-772..................... Pyridoxine Do.
Hydrochloride
Injection, USP,
100 mg/mL.
ANDA 83-775..................... Thiamine Do.
Hydrochloride
Injection, USP,
100 mg/mL.
ANDA 86-519..................... Chlorpheniramine Newtron Pharmaceuticals, Inc.
Maleate Tablets,
USP, 4 mg.
ANDA 86-987..................... Brompheniramine Do.
Maleate Tablets,
USP, 4 mg.
ANDA 87-791..................... Fluorouracil Marcher Laboratories, Ltd.
Injection, 50 mg/
mL.
ANDA 88-871..................... Hydrocodone Abana Pharmaceuticals, Inc.
Bitartrate and
Acetaminophen, 5
mg/500 mg.
ANDA 89-538..................... Meprobamate K. M. Lee Laboratories.
Tablets, USP, 400
mg.
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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 above have repeatedly failed to submit reports
required by Sec. 314.81. Therefore, under this finding, approval of the
applications listed above, and all amendments and supplements thereto,
is hereby withdrawn, effective September 25, 1996.
Dated: August 25, 1996.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 96-24610 Filed 9-24-96; 8:45 am]
BILLING CODE 4160-01-F
