[Federal Register Volume 79, Number 164 (Monday, August 25, 2014)]
[Notices]
[Pages 50659-50660]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-20043]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-P-0549]


Determination That SULAR (Nisoldipine) Extended-Release Tablets, 
10 Milligrams, 20 Milligrams, 25.5 Milligrams, 30 Milligrams, and 40 
Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or 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 
SULAR (nisoldipine) extended-release tablets, 10 milligrams (mg), 20 
mg, 25.5 mg, 30 mg, and 40 mg, were not withdrawn from sale for reasons 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 these drug products, and it will 
allow FDA to approve ANDAs for nisoldipine extended-release tablets, 10 
mg, 20 mg, 25.5 mg, 30 mg, and 40 mg, if all other legal and regulatory 
requirements are met.

FOR FURTHER INFORMATION CONTACT: Emily Gebbia, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6217, Silver Spring, MD 20993-0002, 240-
402-0980.

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 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.
    SULAR (nisoldipine) extended-release tablets, 10 mg, 20 mg, 25.5 
mg, 30 mg, and 40 mg, is the subject of NDA 20-356, held by Shionogi 
Inc., and initially approved on February 2, 1995. SULAR is indicated 
for the treatment of hypertension.
    SULAR (nisoldipine) extended-release tablets, 10 mg, 20 mg, 25.5 
mg, 30 mg, and 40 mg, are currently listed in the ``Discontinued Drug 
Product List'' section of the Orange Book. Emcure Pharmaceuticals USA, 
Inc., submitted a citizen petition dated April 28, 2014 (Docket No. 
FDA-2014-P-0549), under 21 CFR 10.30, requesting that the Agency 
determine whether SULAR (nisoldipine) extended-release tablets, 25.5 
mg, was withdrawn from sale for

[[Page 50660]]

reasons of safety or effectiveness. Although the citizen petition did 
not address the 10 mg, 20 mg, 30 mg, and 40 mg strengths, those 
strengths have also been discontinued. On our own initiative, we have 
also determined whether those strengths were withdrawn for safety or 
effectiveness reasons.
    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 SULAR (nisoldipine) extended-release tablets, 
10 mg, 20 mg, 25.5 mg, 30 mg, and 40 mg were not withdrawn for reasons 
of safety or effectiveness. We have carefully reviewed our files for 
records concerning the withdrawal of SULAR (nisoldipine) extended-
release tablets, 10 mg, 20 mg, 25.5 mg, 30 mg, and 40 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 these products were withdrawn from sale for 
reasons of safety or effectiveness. Moreover, the petitioner has 
identified no data or other information suggesting that SULAR 
(nisoldipine) extended-release tablets, 25.5 mg, was withdrawn for 
reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list SULAR (nisoldipine) 
extended-release tablets, 10 mg, 20 mg, 25.5 mg, 30 mg, and 40 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 the approved ANDAs that refer to SULAR (nisoldipine) 
extended-release tablets. Additional ANDAs that refer to SULAR 
(nisoldipine) extended-release tablets, 10 mg, 20 mg, 25.5 mg, 30 mg, 
and 40 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: August 19, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-20043 Filed 8-22-14; 8:45 am]
BILLING CODE 4164-01-P