[Federal Register Volume 75, Number 201 (Tuesday, October 19, 2010)]
[Notices]
[Pages 64310-64311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-26214]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-P-0234]


Determination That BUSPAR (Buspirone Hydrochloride) Tablets, 10 
Milligrams, 15 Milligrams, and 30 Milligrams, Were Not Withdrawn From 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 
BUSPAR (buspirone hydrochloride) Tablets, 10 milligrams (mg), 15 mg, 
and 30 mg, were not withdrawn from sale for reasons of safety or 
effectiveness. This determination means that FDA will not begin 
procedures to withdraw approval of abbreviated new drug applications 
(ANDAs) that refer to this drug product, and it will allow FDA to 
continue to approve ANDAs that refer to the product as long as they 
meet relevant legal and regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Molly Flannery, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6237, Silver Spring, MD 20993-0002, 301-
796-3543.

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 
applicants 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. ANDA applicants 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 known generally as the ``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 (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. Under Sec.  314.161(a)(2), FDA must determine 
whether a listed drug was withdrawn from sale for reasons of safety or 
effectiveness whenever a listed drug is voluntarily withdrawn from sale 
and ANDAs that refer to the listed drug have been approved. Section 
314.161(d) provides that if FDA determines that a listed drug was 
withdrawn from sale for reasons of safety or effectiveness, the agency 
will initiate proceedings that could result in the withdrawal of 
approval of the ANDAs that refer to the listed drug.
    BUSPAR (buspirone hydrochloride) Tablets, 10 mg, 15 mg, and 30 mg, 
are the subject of NDA 18-731, held by Bristol-Myers Squibb, and 
initially approved on September 29, 1986 (10 mg strength), and April 
22, 1996 (15 mg and 30 mg strengths). BUSPAR is indicated for the 
management of anxiety disorders or the short-term relief of the 
symptoms of anxiety. BUSPAR (buspirone hydrochloride) Tablets, 10 mg, 
15 mg, and 30 mg, are currently listed in the ``Discontinued Drug 
Product List'' section of the Orange Book. There are approved ANDAs for 
buspirone hydrochloride tablets, 10 mg, 15 mg, and 30 mg; these ANDAs 
are listed in the Orange Book and, following the discontinuation of 
BUSPAR, one of them was designated as the reference listed drug to 
which new ANDAs should refer.
    Lachman Consultant Services, Inc., submitted a citizen petition 
dated May 4, 2010 (Docket No. FDA-2010-P-0234), under 21 CFR 10.30, 
requesting that the agency determine whether BUSPAR (buspirone 
hydrochloride) Tablets, 15 mg and 30 mg, were withdrawn from sale for 
reasons of safety or effectiveness. Although the citizen petition did 
not address the 10 mg strength, that strength has also been 
discontinued. On our own initiative, we have also determined whether 
that strength was withdrawn for safety or effectiveness reasons.
    After considering the citizen petition and reviewing agency 
records, FDA has determined under Sec.  314.161 that BUSPAR (buspirone 
hydrochloride) Tablets, 10 mg, 15 mg, and 30 mg, were not withdrawn for 
reasons of safety or effectiveness. The petitioner has identified no 
data or other information suggesting that BUSPAR (buspirone 
hydrochloride) Tablets, 10 mg, 15 mg, and 30 mg, were withdrawn for 
reasons of safety or effectiveness. We have carefully reviewed our 
files for records concerning the withdrawal of BUSPAR (buspirone 
hydrochloride) Tablets, 10 mg, 15 mg, and 30 mg, from sale. We have 
also independently evaluated relevant literature and data for possible 
postmarketing adverse events and have found no information that would 
indicate that this product was

[[Page 64311]]

withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, the agency will continue to list BUSPAR (buspirone 
hydrochloride) Tablets, 10 mg, 15 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. FDA will not begin procedures to withdraw approval of 
approved ANDAs that refer to BUSPAR. Additional ANDAs for buspirone 
hydrochloride tablets, 10 mg, 15 mg, and 30 mg, may also be approved by 
the agency as long as they meet all other legal and regulatory 
requirements for the approval of ANDAs. If FDA determines that labeling 
for this drug product should be revised to meet current standards, the 
agency will advise ANDA applicants to submit such labeling.

    Dated: October 13, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-26214 Filed 10-18-10; 8:45 am]
BILLING CODE 4160-01-P