[Federal Register Volume 61, Number 160 (Friday, August 16, 1996)]
[Notices]
[Pages 42635-42636]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-20899]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket Nos. 80N-0012 and 84N-0067; DESI 10826]
Drug Efficacy Study Implementation; Certain Topical Anti-
Infective Drug Products; Withdrawal of Approval of New Drug
Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
------------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of pertinent parts of the new drug applications (NDA's) for cream and
ointment products containing neomycin sulfate and gramicidin in
addition to nystatin and triamcinolone acetonide. There is a lack of
substantial evidence that the products as originally formulated are
effective in the treatment of various dermatoses and as anti-infective
agents for which they are labeled. Both products have been reformulated
to eliminate neomycin sulfate and gramicidin, and FDA has approved the
reformulated products as safe and effective.
EFECTIVE DATE: September 16, 1996.
ADDRESSES: Requests for guidance on the applicability of this notice to
a specific product should be identified with the Drug Efficacy Study
Implementation (DESI) number 10826 and directed to the Division of
Prescription Drug Compliance and Surveillance (HFD-330), Center for
Drug Evaluation and Research, Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855.
FOR FURTHER INFORMATION CONTACT: Christine F. Rogers, Center for Drug
Evaluation and Research (HFD-366), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-2041.
SUPPLEMENTARY INFORMATION: In a notice of opportunity for a hearing
published in the Federal Register of September 25, 1981 (46 FR 47408),
the Director of the Bureau of Drugs (now the Center for Drug Evaluation
and Research) proposed to withdraw approval of NDA's for certain
topical anti-infective drug products. The proposal was based on the
lack of substantial evidence of effectiveness as required by section
505(e) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C.
355(e)) and 21 CFR 314.126 (previously 21 CFR 314.111(a)(5)). In
response to that notice, requests for a hearing were filed for the
following NDA's:
1. NDA's 60-572 and 60-576; Mycolog Ointment and Cream,
respectively, both containing nystatin (100,000 units per gram (g)),
triamcinolone acetonide (1.0 milligram (mg)/g), neomycin sulfate (2.5
mg/g), and gramicidin (0.25 mg/g); now held by Apothecon, a division of
Bristol-Myers Squibb, P.O. Box 4500, Princeton, NJ 08543-4500.
2. NDA's 61-954 and 62-045; Myco Triacet Cream and Ointment,
respectively, containing nystatin, neomycin sulfate, gramicidin, and
triamcinolone acetonide; held by Lemmon Co., 650 Cathill Rd.,
Sellersville, PA 18960.
3. NDA's 62-135 and 62-136; Nystatin-Neomycin Sulfate-Gramicidin-
Triamcinolone Acetonide Ointment and Cream, respectively; held by E.
Fougera and Co. (formerly Byk Pharmaceutical Group), a division of
Altana, Inc., 60 Baylis Rd., Melville, NY 11747.
4. NDA's 62-186 and 62-280; Nystatin-Neomycin Sulfate-Gramicidin-
Triamcinolone Acetonide Cream and Ointment, respectively; held by Clay-
[[Page 42636]]
Park Labs, Inc. (formerly Clay Park Laboratories), 1700 Bathgate Ave.,
Bathgate Industrial Park, Bronx, NY 10457.
NMC Laboratories, 70-36 83d St., Glendale, NY 11385, filed a
hearing request without reference to a particular product.
In a document published in the Federal Register of April 17, 1985
(50 FR 15227), FDA announced conditions for approval and marketing of
reformulations of both the cream and ointment products that omit
neomycin sulfate and gramicidin. FDA subsequently approved supplemental
NDA's providing for reformulation of all the products listed above.
The drug manufacturers listed above have since withdrawn their
hearing requests. Accordingly, FDA is now withdrawing approval of those
parts of the NDA's listed above pertaining to the products containing
neomycin sulfate and gramicidin.
Antibiotic drug monographs for nystatin-neomycin sulfate-
gramicidin-triamcinolone acetonide ointment and cream products are
cited in 21 CFR 449.550c and 449.550e, respectively. These monographs
will be modified in a future Federal Register notice, if necessary. In
accord with the plans announced by President Clinton on March 4, 1995,
regarding reform of the Federal regulatory system as part of the
Administration's ``Reinventing Government'' initiative, the agency has
initiated the consideration of legislation that would eliminate the
need for publication of antibiotic monographs.
Any drug product that is identical, related, or similar to the
products listed above and is not the subject of an approved NDA is
covered by the NDA's reviewed and is subject to this notice (21 CFR
310.6). Any person who wishes to determine whether a specific product
is covered by this notice should write to the Division of Prescription
Drug Compliance and Surveillance (address above).
The Director of the Center for Drug Evaluation and Research, under
section 505(e) of the act and under authority delegated to her (21 CFR
5.82), finds, on the basis of new information before her with respect
to the cream and ointment products containing neomycin sulfate and
gramicidin, evaluated together with the evidence available to her when
the applications were approved, that there is a lack of substantial
evidence that the products will have the effect they purport or are
represented to have under the conditions of use prescribed,
recommended, or suggested in their labeling.
Therefore, pursuant to the foregoing finding, approval of those
parts of NDA 60-576 and NDA 60-572 that provide for Mycolog Cream and
Ointment, respectively; those parts of NDA 61-954 and NDA 62-045 that
provide for Myco Triacet Cream and Ointment, respectively; those parts
of NDA 62-135 and NDA 62-136 that provide for the cream and ointment,
respectively; and those parts of NDA 62-l86 and NDA 62-280 that provide
for the cream and ointment, respectively, containing neomycin sulfate
and gramicidin, and all the amendments and supplements for these
products, is withdrawn effective September 16, 1996. Shipment in
interstate commerce of the products above or any identical, related, or
similar product that is not the subject of an approved new drug
application will be unlawful as of that effective date.
Dated: June 28, 1996.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 96-20899 Filed 8-15-96; 8:45 am]
BILLING CODE 4160-01-F