[Federal Register: August 7, 2007 (Volume 72, Number 151)]
[Notices]
[Page 44160-44161]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07au07-62]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006P-0125]
Determination That DEXEDRINE (Dextroamphetamine Sulfate) Oral
Solution, 5 Milligrams per 5 Milliliters, Was Not Withdrawn From Sale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
DEXEDRINE (dextroamphetamine sulfate) oral solution, 5 milligrams (mg)
per 5 milliliters (mL), was not withdrawn from sale for reasons of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
oral solution, 5 mg/5 mL.
FOR FURTHER INFORMATION CONTACT: Nikki Mueller, 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 (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 Under FDA regulations, drugs are withdrawn from the list if the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 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.
DEXEDRINE (dextroamphetamine sulfate) oral solution, 5 mg/5 mL, is
the subject of approved ANDA 83-902 held by GlaxoSmithKline (GSK).
DEXEDRINE (dextroamphetamine sulfate) oral solution is indicated for
the treatment of attention deficit hyperactivity disorder (ADHD). GSK's
ANDA 83-902 was originally approved in 1976 and was discontinued in
1988. Lachman Consultant Services, Inc., submitted a citizen petition
dated March 17, 2006 (Docket No. 2006P-0125/CP1), under 21 CFR 10.30,
requesting that the agency determine, as described in Sec. 314.161,
whether DEXEDRINE (dextroamphetamine sulfate) oral solution, 5 mg/5 mL,
was withdrawn from sale for reasons of safety or effectiveness.
After considering the citizen petition and reviewing agency
records, FDA has determined that GSK's DEXEDRINE (dextroamphetamine
sulfate) oral solution, 5 mg/5 mL, was not withdrawn from sale for
reasons of safety or effectiveness. In support of this finding, we note
that DEXEDRINE (dextroamphetamine sulfate) is available in an extended
release capsule form and is a widely used product that has been
marketed for many decades in many dosage forms. Neither the petition
nor any comment to the petition identified evidence suggesting that
DEXEDRINE (dextroamphetamine sulfate) oral solution, 5 mg/5 mL, was
withdrawn from sale for reasons of safety or effectiveness. FDA has
independently evaluated relevant literature and data for adverse event
reports and has found no information that would indicate that DEXEDRINE
(dextroamphetamine sulfate) oral solution, 5 mg/5 mL, was withdrawn for
reasons of safety or effectiveness.
For the reasons outlined in this document, FDA determines that
GSK's DEXEDRINE (dextroamphetamine sulfate) oral solution, 5 mg/5 mL,
was not withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the agency will continue to list DEXEDRINE
(dextroamphetamine sulfate) oral
[[Page 44161]]
solution, 5 mg/5 mL, 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 DEXEDRINE (dextroamphetamine sulfate) oral solution, 5 mg/5
mL, may be approved by the agency as long as they meet all relevant
legal and regulatory requirements for the approval of ANDAs. If FDA
determines that labeling for these drug products should be revised to
meet current standards, the agency will advise ANDA applicants to
submit such labeling.
Dated: July 30, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-15236 Filed 8-6-07; 8:45 am]
BILLING CODE 4160-01-S