[Federal Register Volume 75, Number 217 (Wednesday, November 10, 2010)]
[Notices]
[Pages 69088-69089]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-28358]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-P-0273]
Determination That Amphetamine Sulfate, 5 and 10 Milligram
Tablets, Was Not Withdrawn From Sale for Reasons of Safety or
Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) has determined that
Amphetamine sulfate, 5 and 10 milligram (mg) tablets, was not withdrawn
from sale for reasons of safety or effectiveness. This determination
will allow FDA to approve abbreviated new drug applications (ANDAs) for
Amphetamine sulfate, 5 mg and 10 mg tablets, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Patrick Raulerson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6368, Silver Spring, MD 20993-0002, 301-
796-3522.
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
applicants must, with certain exceptions, show that the drug for which
they are seeking approval contains the same active ingredient in the
same strength and dosage form as the ``listed drug,'' which is a
version of the drug that was previously approved. ANDA applicants do
not have to repeat the extensive clinical testing otherwise necessary
to gain approval of a new drug application (NDA). The only clinical
data required in an ANDA are data to show that the drug that is the
subject of the ANDA is bioequivalent to the listed drug.
[[Page 69089]]
The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162). Under Sec. 314.161(a)(1) (21 CFR 314.161(a)(1)), the
Agency must determine whether a listed drug was withdrawn from sale for
reasons of safety or effectiveness before an ANDA that refers to that
listed drug may be approved. FDA may not approve an ANDA that does not
refer to a listed drug.
Amphetamine sulfate, 5 mg and 10 mg tablets, is the subject of ANDA
083901 held by Lannett Company Inc. (Lannett). Amphetamine sulfate is a
sympathomimetic amine indicated for treatment of narcolepsy, attention
deficit disorder with hyperactivity, and exogenous obesity, as
described in the labeling.
In a letter dated April 4, 1994, Lannett notified FDA that
Amphetamine sulfate, 5 mg and 10 mg tablets, had been discontinued, and
FDA moved the drug product to the ``Discontinued Drug Product List''
section of the Orange Book.
Lachman Consultant Services submitted a citizen petition dated June
12, 2009 (Docket No. FDA-2009-P-0273), under 21 CFR 10.30, requesting
that the Agency determine whether Amphetamine sulfate, 5 mg and 10 mg
tablets, was withdrawn from sale for reasons of safety or
effectiveness.
After considering the citizen petition and reviewing Agency
records, FDA has determined under Sec. 314.161 that Amphetamine
sulfate, 5 mg and 10 mg tablets, was not withdrawn for reasons of
safety or effectiveness. The petitioner has identified no data or other
information suggesting that Amphetamine sulfate, 5 mg and 10 mg
tablets, was withdrawn for reasons of safety or effectiveness. We have
carefully reviewed our files for records concerning the withdrawal of
Amphetamine sulfate, 5 mg and 10 mg tablets, from sale. We have also
independently evaluated relevant literature and data for possible
postmarketing adverse events and have found no information that would
indicate that this product was withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will continue to list Amphetamine sulfate,
5 mg and 10 mg tablets, in the ``Discontinued Drug Product List''
section of the Orange Book. The ``Discontinued Drug Product List''
delineates, among other items, drug products that have been
discontinued from marketing for reasons other than safety or
effectiveness. ANDAs that refer to Amphetamine sulfate, 5 mg and 10 mg
tablets, may be approved by the Agency as long as they meet all other
legal and regulatory requirements for the approval of ANDAs. If FDA
determines that labeling for this drug product should be revised to
meet current standards, the Agency will advise ANDA applicants to
submit such labeling.
Dated: November 3, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-28358 Filed 11-9-10; 8:45 am]
BILLING CODE 4160-01-P