[Federal Register Volume 68, Number 217 (Monday, November 10, 2003)]
[Notices]
[Pages 63804-63805]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-28193]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2002P-0431]


Determination That Delcobese (Amphetamine Adipate, Amphetamine 
Sulfate, Dextroamphetamine Adipate, Dextroamphetamine Sulfate) Tablets 
and Capsules Were Not Withdrawn From Sale for Reasons of Safety or 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 
Delcobese (amphetamine adipate, amphetamine sulfate, dextroamphetamine 
adipate, dextroamphetamine sulfate) tablets and capsules were not 
withdrawn from sale for reasons of safety or effectiveness. This 
determination will allow FDA to approve abbreviated new drug 
applications (ANDAs) for generic versions of Delcobese tablets and 
capsules.

FOR FURTHER INFORMATION CONTACT: Aileen H. Ciampa, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) 
(the 1984 amendments), 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 that 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 (the 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 ``Approved Drug Products with 
Therapeutic Equivalence Evaluations,'' which is generally known as the 
``Orange Book.'' Under FDA 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 (Sec.  314.162) (21 CFR 314.162)).
    Under 314.161(a)(1) of the act (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.
    Delcobese (amphetamine adipate, amphetamine sulfate, 
dextroamphetamine adipate, dextroamphetamine sulfate) tablets (1.25 
milligrams (mg), 2.5 mg, 3.75 mg, 5 mg) were the subject of approved 
ANDA 83-563. Delcobese (amphetamine adipate, amphetamine sulfate, 
dextroamphetamine adipate, dextroamphetamine sulfate) capsules (1.25 
mg, 2.5 mg, 3.75 mg, 5 mg) were the subject of approved ANDA 83-564. 
Both ANDAs were submitted by Delco Chemical Co., but ownership was 
later transferred to Lemmon Co. Delcobese tablets and capsules were 
labeled for the following indications: (1) Narcolepsy; (2) behavioral 
syndrome characterized by hyperactivity, distractability, and 
impulsiveness in children (currently commonly known as attention 
deficit hyperactivity disorder or ADHD); and (3) exogenous obesity. 
Prior to Delcobese's discontinuation, FDA proposed to remove the 
exogenous obesity indication from the labeling of all drug products 
containing an amphetamine, including Delcobese products, and offered 
the application holders an opportunity for hearing (44 FR 41552, July 
17, 1979). That notice is still pending. While it is pending, the 
exogenous obesity indication may not be approved for ANDAs relying on 
Delcobese tablets or capsules as their listed drug (21 CFR 
314.127(a)(9)).
    On February 22, 1985, Lemmon Co. notified FDA that Delcobese 
capsules had not been manufactured since March 1984. On June 4, 1990, 
FDA requested that Lemmon Co. withdraw ANDAs 83-563 and 83-564 because 
the marketing of both Delcobese capsules and tablets had been 
discontinued. On February 24, 1993, Lemmon Co. requested the withdrawal 
of ANDAs 83-563 and 83-564. Accordingly, FDA withdrew approval of the 
applications in a Federal Register notice (58 FR 27737, May 11, 1993). 
Delcobese was moved from the prescription drug product list to the 
``Discontinued Drug Product List'' section of the Orange Book.
    In a citizen petition submitted under 21 CFR 10.30 dated September 
20, 2002 (Docket No. 02P-0431), as amended by a letter dated October 
23, 2002, Sonnenschein Nath & Rosenthal requested that FDA determine 
whether Delcobese tablets and capsules were withdrawn from sale for 
reasons of safety or effectiveness.
    The agency has determined that Delcobese tablets and capsules were 
not withdrawn from sale for reasons of safety or effectiveness. The 
petitioners identified no data or other information suggesting that 
Delcobese tablets and capsules were withdrawn from sale as a result of 
safety or effectiveness concerns. FDA has independently evaluated 
relevant data, including postmarketing adverse event reports, but

[[Page 63805]]

has found no information that would indicate this product was withdrawn 
for reasons of safety or effectiveness. Finally, an NDA for a similar 
amphetamine/dextroamphetamine salt combination was recently approved 
after the product was found to be safe and effective for the treatment 
of ADHD.
    After considering the citizen petition and reviewing its records, 
FDA determines that, for the reasons outlined above, Delcobese tablets 
and capsules, approved under ANDAs 83-563 and 83-564, were not 
withdrawn from sale for reasons of safety or effectiveness. 
Accordingly, the agency will continue to list Delcobese tablets and 
capsules 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. As a result, ANDAs that 
refer to Delcobese tablets and capsules may be approved by the agency 
for appropriate indications.

    Dated: November 3, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.

[FR Doc. 03-28193 Filed 11-7-03; 8:45 am]
BILLING CODE 4160-01-S