[Federal Register Volume 63, Number 130 (Wednesday, July 8, 1998)]
[Notices]
[Pages 36923-36924]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-18140]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 78N-0070; DESI 1626]
Combination Drugs Containing Theophylline, Ephedrine Sulfate, and
Hydroxyzine Hydrochloride; Withdrawal of Approval
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of the new drug applications (NDA's) for Marax Tablets and Marax
[[Page 36924]]
Syrup. FDA is also declaring all identical, similar, and related drug
products, not otherwise subject to an approved drug application,
unlawful, including Brofed Tablets and Hydroxyzine Compound Syrup. Each
of these products contains theophylline, ephedrine sulfate, and
hydroxyzine hydrochloride. The basis of the withdrawals is that there
is a lack of substantial evidence that these combination drugs are
effective for the treatment of bronchial asthma.
EFFECTIVE DATE: August 7, 1998.
ADDRESSES: Requests for applicability of this notice to a specific
product should be identified with the Docket and DESI numbers found in
brackets in the heading of this document 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: Mary E. Catchings, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2041.
SUPPLEMENTARY INFORMATION: As part of the agency's drug efficacy
program, in a notice published in the Federal Register of September 17,
1984 (49 FR 36443), the Commissioner of Food and Drugs granted an
evidentiary hearing before an administrative law judge on the proposal
to withdraw approval of NDA 11-768 for Marax Tablets and NDA 12-879 for
Marax Syrup, each containing theophylline, ephedrine sulfate, and
hydroxyzine hydrochloride. The NDA's are held by J. B. Roerig, Division
of Pfizer, Inc. (Pfizer), 235 East 42d St., New York, NY 10017.
Other party participants were:
1. Barre-National, Inc., 4128 Haywood Ave., Baltimore, MD 21215
(Barre); Hydroxyzine Compound Syrup (no NDA).
2. Cord Laboratories, Inc. (now Geneva Pharmaceuticals, Inc.), 2555
West Midway Blvd., Broomfield, CO 80038 (Cord); Brofed Tablets (no
NDA).
3. Barrows Research Group, Inc., 99 West Hawthorne Ave., Valley
Stream, NY 11580 (Barrows). Unnamed drug product. Barrows later
withdrew its hearing request.
Subsequently, in accordance with agreements to resolve, by other
means, the issue of their drug products' effectiveness, Pfizer, Barre,
and Cord withdrew their hearing requests. Under those agreements, FDA
has concluded that Marax Tablets and Marax Syrup have not been shown to
be effective, and FDA is now withdrawing approval of the NDA's for
these products.
This notice applies to any drug product that is identical, related,
or similar to these products and is not the subject of an approved NDA
(21 CFR 310.6). Such products include Hydroxyzine Compound Syrup and
Brofed Tablets, each of which contains theophylline, ephedrine sulfate,
and hydroxyzine hydrochloride. 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 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355)
and under the authority delegated to her (21 CFR 5.82), finds that on
the basis of new information before her with respect to Marax Tablets
and Marax Syrup, evaluated together with the evidence available to her
when the applications were approved, 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, based on the foregoing finding, approvals and all the
amendments and supplements thereto of NDA 11-768 and NDA 12-879 are
withdrawn effective August 7, 1998. Shipment in interstate commerce of
the products listed above or of any identical, related, or similar
product that is not the subject of an approved NDA will then be
unlawful.
Dated: June 15, 1998.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 98-18140 Filed 7-7-98; 8:45 am]
BILLING CODE 4160-01-F
