[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Milligrams, 15 Milligrams, and 30 Milligrams, Were Not Withdrawn From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and 30 mg, were not withdrawn from sale for reasons of safety or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