[Federal Register Volume 74, Number 231 (Thursday, December 3, 2009)]
[Notices]
[Pages 63404-63405]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-28871]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-P-0330]


Determination That ABILIFY DISCMELT (Aripiprazole) Orally 
Disintegrating Tablets, 20 Milligrams and 30 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Withdrawn From Sale for Reasons of Safety or Effectiveness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 
ABILIFY DISCMELT (aripiprazole) orally disintegrating tablets, 20 
milligrams (mg) and 30 mg, were not withdrawn from sale for reasons of 
safety or effectiveness. This determination will allow FDA to approve 
abbreviated new drug applications (ANDAs) for aripiprazole orally 
disintegrating tablets, 20 mg and 30 mg, if all other legal and 
regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT:  Nam Kim, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, rm. 6320, Silver Spring, MD 20993-0002, 301-796-3601.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Pub. L. 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

[[Page 63405]]

``Orange Book.'' Under FDA regulations, drugs are removed 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 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.
    ABILIFY DISCMELT (aripiprazole) orally disintegrating tablets, 20 
mg and 30 mg, are the subject of approved NDA 21-729 held by Otsuka 
Pharmaceutical Company, Limited (Otsuka). ABILIFY (aripiprazole) is 
indicated for the treatment of schizophrenia, for the acute and 
maintenance treatment of manic and mixed episodes associated with 
bipolar I disorder, as an adjunctive therapy to either lithium or 
valproate for the acute treatment of manic and mixed episodes 
associated with bipolar I disorder, for use as an adjunctive therapy to 
antidepressants for the treatment of major depressive disorder, for the 
treatment of irritability associated with autistic disorder, and for 
the acute treatment of agitation associated with schizophrenia or 
bipolar I disorder, manic or mixed.
    FDA approved the NDA for ABILIFY DISCMELT (aripiprazole) orally 
disintegrating tablets, including the 20-mg and 30-mg strengths, on 
June 7, 2006. Otsuka has never marketed the 20-mg and 30-mg strengths 
of ABILIFY DISCMELT (aripiprazole) orally disintegrating tablets, and 
the 20-mg and 30-mg strength orally disintegrating tablets are listed 
in the ``Discontinued Drug Product List'' of the Orange Book.
    Rakoczy Molino Mazzochi Siwik LLP submitted a citizen petition 
dated May 29, 2008 (Docket No. FDA-2008-P-0330), under 21 CFR 10.30, 
requesting that the agency (1) determine that ABILIFY DISCMELT 
(aripiprazole) orally disintegrating tablets, 20 mg and 30 mg, were 
discontinued from sale for reasons unrelated to safety and efficacy and 
(2) accept ANDAs for aripiprazole orally disintegrating tablets, 20 mg 
and 30 mg, and determine that such ANDAs are eligible for approval if 
all other legal and regulatory requirements are met. After considering 
the citizen petition and reviewing agency records, FDA has determined 
that ABILIFY DISCMELT (aripiprazole) orally disintegrating tablets, 20 
mg and 30 mg, were not withdrawn from sale for reasons of safety or 
effectiveness. To date, Otsuka has not marketed ABILIFY DISCMELT 
(aripiprazole) orally disintegrating tablets, 20 mg and 30 mg. In 
previous instances (see, e.g., 72 FR 9763, March 5, 2007; 61 FR 25497, 
May 21, 1996), the agency has determined that, for purposes of 
Sec. Sec.  314.161 and 314.162, never marketing an approved drug 
product is equivalent to withdrawing the drug from sale.
    The petitioner identified no data or other information suggesting 
that ABILIFY DISCMELT (aripiprazole) orally disintegrating tablets, 20 
mg and 30 mg, were withdrawn from sale as a result of safety or 
effectiveness concerns. FDA has reviewed its files for records 
concerning the withdrawal of ABILIFY DISCMELT (aripiprazole) orally 
disintegrating tablets, 20 mg and 30 mg. There is no indication that 
Otsuka's decision not to market ABILIFY DISCMELT (aripiprazole) orally 
disintegrating tablets, 20 mg and 30 mg, commercially is a function of 
safety or effectiveness concerns, and no information has been submitted 
to the docket concerning the reason for which ABILIFY DISCMELT 
(aripiprazole) orally disintegrating tablets, 20 mg and 30 mg, were 
withdrawn from sale. FDA's independent evaluation of relevant 
information has uncovered nothing that would indicate that ABILIFY 
DISCMELT (aripiprazole) orally disintegrating tablets, 20 mg and 30 mg, 
were withdrawn from sale for reasons of safety or effectiveness.
    For the reasons outlined in this document, FDA has determined that 
ABILIFY DISCMELT (aripiprazole) orally disintegrating tablets, 20 mg 
and 30 mg, were not withdrawn from sale for reasons of safety or 
effectiveness. Accordingly, the agency will continue to list ABILIFY 
DISCMELT (aripiprazole) orally disintegrating tablets, 20 mg and 30 mg, 
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 ABILIFY 
DISCMELT (aripiprazole) orally disintegrating tablets, 20 mg and 30 mg, 
may be approved by the agency as long as they meet all relevant legal 
and regulatory requirements for 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: November 30, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-28871 Filed 12-2-09; 8:45 am]
BILLING CODE 4160-01-S