Document ID: FDA-2014-N-0199-0002
Agency: fda
Document Type: Notice
Title: MK Laboratories, Inc., et al.; Withdrawal of Approval of 3
Abbreviated New Drug Applications for Propoxyphene Products
Posted Date: 2014-09-12T04:00Z

[Federal Register Volume 79, Number 177 (Friday, September 12, 2014)]
[Notices]
[Pages 54729-54730]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-21729]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0199]

MK Laboratories, Inc., et al.; Withdrawal of Approval of 3 
Abbreviated New Drug Applications for Propoxyphene Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of three abbreviated new drug applications (ANDAs) for products 
containing propoxyphene. The basis for the withdrawals is that the 
products are no longer shown to be safe because propoxyphene puts 
patients at risk of potentially serious and even fatal heart rhythm 
abnormalities. The holders of these ANDAs have waived their opportunity 
for a hearing.

DATES: Effective September 12, 2014.

FOR FURTHER INFORMATION CONTACT: David Joy, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave. 
Bldg. 51, Rm. 6254, Silver Spring, MD 20993-0002, 301-796-3601.

SUPPLEMENTARY INFORMATION: On November 18, 2010, after receiving 
clinical data and other information showing that propoxyphene puts 
patients at risk of potentially serious and even fatal heart rhythm 
abnormalities, FDA asked manufacturers of then marketed branded and 
generic propoxyphene drug products to voluntarily withdraw the products 
from the U.S. market. In a notice published in the Federal Register of 
March 10, 2014 (79 FR 13308), FDA withdrew approval of 8 new drug 
applications (NDAs) and 46 ANDAs for propoxyphene drug products from 
multiple sources whose application holders agreed in writing to waive 
their opportunity for a hearing and permit FDA to withdraw approval of 
the applications. In a separate notice published in the Federal 
Register of March 10, 2014 (79 FR 13310), FDA's Center for Drug 
Evaluation and Research (CDER) notified the holders of 3 other approved 
ANDAs for propoxyphene drug products of their opportunity to request a 
hearing on CDER's proposal to issue an order, under section 505(e) of 
the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 
355(e)), withdrawing approval of 3 ANDAs for propoxyphene drug 
products. The following products, all of which FDA

[[Page 54730]]

believes were discontinued prior to November 2010, were listed in the 
notice.

 Table 1--Propoxyphene Drug Product Applications for Which FDA Proposed
                          To Withdraw Approval
------------------------------------------------------------------------
    Application No.                Drug             Applicant or holder
------------------------------------------------------------------------
ANDA 083544............  Kesso-Gesic              MK Laboratories Inc.,
                          (propoxyphene            424 Grasmere Ave.,
                          hydrochloride (HCl))     Fairfield, CT 06430.
                          Capsules, 65
                          milligrams (mg).
ANDA 084551............  Propoxyphene HCl         Whiteworth Towne
                          Capsules, 65 mg.         Paulsen Inc.
ANDA 084553............  Compound 65 (aspirin,    Alra Labs, 3850
                          caffeine, and            Clearview Ct.,
                          propoxyphene HCl)        Gurnee, IL 60031.
                          Capsules, 389 mg/32.4
                          mg/65 mg.
------------------------------------------------------------------------

    In its March 10, 2014, notice of opportunity for a hearing, CDER 
provided these ANDA holders an opportunity to request a hearing to show 
why approval of the ANDAs should not be withdrawn. No timely request 
for a hearing on this matter was received following publication of the 
notice in the Federal Register.
    Therefore, under section 505(e) of the FD&C Act and under authority 
delegated to the Director of CDER by the Commissioner of Food and 
Drugs, approval of the applications listed in table 1 and all 
amendments and supplements thereto is withdrawn (see DATES). 
Introduction or delivery for introduction of these products into 
interstate commerce without an approved application is illegal and 
subject to regulatory action (see sections 505(a) and 301(d) of the 
FD&C Act (21 U.S.C. 331(d))).

    Dated: September 5, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-21729 Filed 9-11-14; 8:45 am]
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