[Federal Register Volume 67, Number 202 (Friday, October 18, 2002)]
[Notices]
[Pages 64398-64399]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-26473]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01P-0252]


Determination That Dextroamphetamine Sulfate Tablets, 15 
Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or 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 
dextroamphetamine sulfate 15-milligram (mg) tablets (formerly marketed 
by Lannett Co., Inc.) were not withdrawn from sale for reasons of 
safety or effectiveness. This determination will allow FDA to approve 
abbreviated new drug applications (ANDAs) for dextroamphetamine sulfate 
15-mg tablets.

FOR FURTHER INFORMATION CONTACT: Mary E. Catchings, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20855, 301-594-2041.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (the 1984 
amendments) (Public Law 98-417), which authorized the approval of 
duplicate versions of drug products approved under an ANDA procedure. 
ANDA sponsors 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 which was previously approved. Sponsors of ANDAs 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.
    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 generally known as the ``Orange 
Book.'' Under FDA's regulations, drugs are withdrawn from the list if 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 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.
    Dextroamphetamine sulfate tablets, 15 mg, are the subject of 
approved ANDA 85-652 held by Lannett Co., Inc. Dextroamphetamine 
sulfate tablets are indicated for narcolepsy and for attention deficit 
disorder with hyperactivity. Lannett Co., Inc.'s, dextroamphetamine 
sulfate 15-mg tablets are currently listed in the ``Discontinued Drug 
Product List'' section of the Orange Book.
    On May 17, 2001, Mallinckrodt, Inc., submitted a citizen petition 
(Docket No. 01P-0252/CP1) to FDA under 21 CFR 10.20 and 10.30. The 
petition, as amended July 26, 2001, requested that the agency determine 
that dextroamphetamine sulfate tablets, 15 mg, were not withdrawn from 
the market for reasons of safety or effectiveness.
    The agency has determined that dextroamphetamine sulfate tablets, 
15 mg, were not withdrawn from sale for reasons of safety or 
effectiveness. There are several grounds for FDA's finding. First, 
there are drug products containing 15-mg dextroamphetamine sulfate 
being marketed today. Although these drug products are extended release 
products rather than immediate release products, FDA has concluded that 
this difference does not affect the product's safety. Second, the 
petitioner identified no data or other information suggesting that 
dextroamphetamine sulfate tablets, 15 mg, were withdrawn from sale as a 
result of safety or effectiveness concerns. Third, Lannett Company, 
Inc.,

[[Page 64399]]

informed FDA in June 1993 that its entire product line had been 
recalled following a change in management, and the agency has found no 
information that would lead it to conclude otherwise. Finally, FDA has 
also independently evaluated relevant literature and data for possible 
postmarketing adverse event reports, but has found no information that 
would indicate this product was withdrawn from sale for reasons of 
safety or effectiveness.
    After considering the citizen petition and reviewing its records, 
FDA determines that, for the reasons outlined above, Lannett Co.'s 
dextroamphetamine sulfate tablets, 15 mg, were not withdrawn from sale 
for reasons of safety or effectiveness. Accordingly, the agency will 
continue to list dextroamphetamine sulfate tablets, 15 mg, in the 
``Discontinued Drug Product List'' section of the Orange Book. The 
``Discontinued Drug Product List'' identifies, among other items, drug 
products that have been discontinued from marketing for reasons other 
than safety or effectiveness. ANDAs that refer to dextroamphetamine 
sulfate tablets, 15 mg, may be approved by the agency.

    Dated: October 10, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-26473 Filed 10-17-02; 8:45 am]
BILLING CODE 4160-01-S