[Federal Register Volume 77, Number 171 (Tuesday, September 4, 2012)]
[Notices]
[Pages 53892-53893]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-21652]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-P-0458]


Determination That ALOXI (Palonosetron Hydrochloride) Capsules, 
0.5 Milligram (Base), Were Not Withdrawn From Sale for Reasons of 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 
ALOXI (palonosetron hydrochloride (HCl)) Capsules, 0.5 milligram (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(base), were not withdrawn from sale for reasons of safety or 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 palonosetron HCl capsules, 0.5 mg 
(base), if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Molly Flannery, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6246, 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 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.
    ALOXI (palonosetron HCl) Capsules, 0.5 mg (base), is the subject of 
NDA 22-233, held by Helsinn Healthcare, and initially approved on 
August 22, 2008. ALOXI is indicated for the prevention of acute nausea 
and vomiting associated with initial and repeat courses of moderately 
emetogenic cancer chemotherapy.
    Helsinn Healthcare has never marketed ALOXI (palonosetron HCl) 
Capsules, 0.5 mg (base). 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.
    Lachman Consultant Services, Inc. submitted a citizen petition 
dated May 7, 2012 (Docket No. FDA-2012-P-0458), under 21 CFR 10.30, 
requesting that the Agency determine whether ALOXI (palonosetron HCl) 
Capsules, 0.5 mg (base), were withdrawn 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 ALOXI (palonosetron HCl) Capsules, 0.5 mg 
(base), were not withdrawn for reasons of safety or effectiveness. The 
petitioner has identified no data or other information suggesting that 
ALOXI (palonosetron HCl) Capsules, 0.5 mg (base), were withdrawn for 
reasons of safety or effectiveness. We have carefully reviewed our 
files for records concerning the withdrawal of ALOXI (palonosetron HCl) 
Capsules, 0.5 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 ALOXI (palonosetron 
HCl) Capsules, 0.5 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 ALOXI (palonosetron HCl) Capsules, 
0.5 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.


[[Page 53893]]


    Dated: August 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-21652 Filed 8-31-12; 8:45 am]
BILLING CODE 4160-01-P