[Federal Register Volume 77, Number 34 (Tuesday, February 21, 2012)]
[Notices]
[Pages 9944-9945]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-3954]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-P-0170]


Determination That REQUIP XL (Ropinerole Hydrochloride) Extended-
Release Tablets, 3 Milligrams, Were Not Withdrawn From Sale for Reasons 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 
REQUIP XL (ropinerole hydrochloride) extended-release tablets, 3 
milligrams (mg), were not withdrawn from sale for reasons of safety or 
effectiveness. This determination will allow FDA to approve abbreviated 
new drug applications (ANDAs) for ropinerole hydrochloride extended-
release tablets, 3 mg, if all other legal and regulatory requirements 
are met.

FOR FURTHER INFORMATION CONTACT: Jay Sitlani, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6370, 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 
(Sec.  314.162 (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.
    REQUIP XL (ropinerole hydrochloride) extended-release tablets, 3 
mg, are the subject of NDA 22-008, held by GlaxoSmithKline, and 
initially approved on June 13, 2008. REQUIP XL is indicated for the 
treatment of treatment of signs and symptoms of idiopathic Parkinson's 
disease.
    REQUIP XL (ropinerole hydrochloride) extended-release tablets, 3 
mg, are currently listed in the ``Discontinued Drug Product List'' 
section of the Orange Book. GlaxoSmithKline has never marketed REQUIP 
XL (ropinerole hydrochloride) extended-release tablets, 3 mg. In 
previous instances (see, e.g., 72 FR 9763, 61 FR 25497), 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 April 1, 2009 (Docket No. FDA-2009-P-0170), under 21 CFR 10.30, 
requesting that the Agency determine whether REQUIP XL (ropinerole 
hydrochloride) extended-release tablets, 3 mg, were withdrawn from sale 
for reasons of safety or effectiveness.

[[Page 9945]]

    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 REQUIP XL (ropinerole hydrochloride) extended-
release tablets, 3 mg, were not withdrawn for reasons of safety or 
effectiveness. The petitioner has identified no data or other 
information suggesting that REQUIP XL (ropinerole hydrochloride) 
extended-release tablets, 3 mg, were withdrawn for reasons of safety or 
effectiveness. We have carefully reviewed our files for records 
concerning the withdrawal of REQUIP XL (ropinerole hydrochloride) 
extended-release tablets, 3 mg, 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 REQUIP XL (ropinerole 
hydrochloride) extended-release tablets, 3 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. ANDAs that refer to REQUIP XL (ropinerole hydrochloride) 
extended-release tablets, 3 mg, 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: February 14, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-3954 Filed 2-17-12; 8:45 am]
BILLING CODE 4160-01-P