[Federal Register Volume 72, Number 151 (Tuesday, August 7, 2007)]
[Notices]
[Pages 44160-44161]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-15236]


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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Solution, 5 Milligrams per 5 Milliliters, Was Not Withdrawn From Sale 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per 5 milliliters (mL), was not withdrawn from sale for reasons of 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 Under FDA regulations, drugs are withdrawn from the list if the 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