[Federal Register: November 10, 2003 (Volume 68, Number 217)]
[Notices]
[Page 63804-63805]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10no03-48]
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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and Capsules Were Not Withdrawn From Sale for Reasons of Safety or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withdrawn from sale for reasons of safety or effectiveness.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 Under FDA regulations, drugs are withdrawn from the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