[Federal Register Volume 76, Number 168 (Tuesday, August 30, 2011)]
[Notices]
[Pages 53907-53908]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-22145]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-P-0460]


Determination That TALWIN COMPOUND (Aspirin; Pentazocine 
Hydrochloride) Tablets, 325 Milligrams; Equivalent to 12.5 Milligram 
Base, Were Not Withdrawn From Sale for Reasons of Safety or 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 
TALWIN COMPOUND (aspirin; pentazocine hydrochloride (HCl)) tablets, 325 
milligrams (mg); equivalent to (EQ) 12.5 mg base, were not withdrawn 
from sale for reasons of safety or effectiveness. This determination 
will allow FDA to approve abbreviated new drug applications (ANDAs) for 
aspirin; pentazocine HCl tablets, 325 mg; EQ 12.5 mg base, 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 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).
    A person may petition the Agency to determine, or the Agency may 
determine on its own initiative, whether a listed drug was withdrawn 
from sale for reasons of safety or effectiveness. This determination 
may be made at any time after the drug has been withdrawn from sale, 
but must be made prior to approving an ANDA that refers to the listed 
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that 
does not refer to a listed drug.
    TALWIN COMPOUND (aspirin; pentazocine HCl) tablets, 325 mg; EQ 12.5 
mg base, are the subject of NDA 016891, held by Sanofi-aventis U.S., 
and initially approved on November 12, 1975. TALWIN COMPOUND tablets 
are indicated for the relief of moderate pain.
    TALWIN COMPOUND (aspirin; pentazocine HCl) tablets, 325 mg; EQ 12.5 
mg base, are currently listed in the

[[Page 53908]]

``Discontinued Drug Product List'' section of the Orange Book.
    Lachman Consultant Services, Inc., submitted a citizen petition 
dated June 7, 2011 (Docket No. FDA-2011-P-0460), under 21 CFR 10.30, 
requesting that the Agency determine whether TALWIN COMPOUND (aspirin; 
pentazocine HCl) tablets, 325 mg; EQ 12.5 mg base, have been 
voluntarily withdrawn or withheld from sale for reasons of safety or 
effectiveness.
    After considering the citizen petition and reviewing Agency records 
and based on the information we have at this time, FDA has determined 
under Sec.  314.161 that TALWIN COMPOUND (aspirin; pentazocine HCl) 
tablets, 325 mg; EQ 12.5 mg base, were not withdrawn for reasons of 
safety or effectiveness. The petitioner has identified no data or other 
information suggesting that TALWIN COMPOUND (aspirin; pentazocine HCl) 
tablets, 325 mg; EQ 12.5 mg base, were withdrawn for reasons of safety 
or effectiveness. We have carefully reviewed our files for records 
concerning the withdrawal of TALWIN COMPOUND (aspirin; pentazocine HCl) 
tablets, 325 mg; EQ 12.5 mg base, from sale. We have also independently 
evaluated relevant literature and data for possible postmarketing 
adverse events. We have found no information that would indicate that 
this product was withdrawn from sale for reasons of safety or 
effectiveness.
    Accordingly, the Agency will continue to list TALWIN COMPOUND 
(aspirin; pentazocine HCl) tablets, 325 mg; EQ 12.5 mg base, 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 TALWIN COMPOUND 
(aspirin; pentazocine HCl) tablets, 325 mg; EQ 12.5 mg base, may 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: August 25, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-22145 Filed 8-29-11; 8:45 am]
BILLING CODE 4160-01-P