[Federal Register Volume 78, Number 21 (Thursday, January 31, 2013)]
[Notices]
[Page 6823]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-02087]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-P-0916]


Determination That DIFFERIN (Adapalene) Solution, 0.1%, Was 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Withdrawn From Sale for Reasons of Safety or Effectiveness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 
DIFFERIN (adapalene) solution, 0.1% (NDA 20-338), was not withdrawn 
from sale for reasons of safety or effectiveness. This determination 
will allow FDA to approve abbreviated new drug applications (ANDAs) for 
adapalene solution, 0.1%, if all other legal and regulatory 
requirements are met.

FOR FURTHER INFORMATION CONTACT: Nisha Shah, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, rm. 6222, Silver Spring, MD 20993-0002, 301-796-4455.

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 approved 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). Under Sec.  314.161(a)(1) (21 CFR 314.161(a)(1)), the 
Agency must determine whether a listed drug was withdrawn from sale for 
reasons of safety or effectiveness before an ANDA that refers to that 
listed drug may be approved. FDA may not approve an ANDA that does not 
refer to a listed drug.
    DIFFERIN (adapalene) solution, 0.1%, is the subject of NDA 20-338, 
held by Galderma Laboratories, L.P., and initially approved on May 31, 
1996, and is indicated for the topical treatment of acne vulgaris. This 
product is currently listed in the ``Discontinued Drug Product List'' 
section of the Orange Book.
    Ei, Inc., on behalf of Call, Inc. (d/b/a Rochester 
Pharmaceuticals), submitted a citizen petition dated August 23, 2012 
(Docket No. FDA-2012-P-0916), under 21 CFR 10.30, requesting that the 
Agency determine whether DIFFERIN (adapalene) solution, 0.1%, was 
withdrawn from sale for reasons of safety or effectiveness.
    After considering the citizen petition and reviewing Agency 
records, FDA has determined under Sec.  314.161 that DIFFERIN 
(adapalene) solution, 0.1%, was not withdrawn for reasons of safety or 
effectiveness. The petitioner has identified no data or other 
information suggesting that this product was withdrawn for reasons of 
safety or effectiveness. We have carefully reviewed our files for 
records concerning the withdrawal of DIFFERIN (adapalene) solution, 
0.1%, from sale. We also have independently evaluated relevant 
literature and data for possible postmarketing adverse events and 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 DIFFERIN (adapalene) 
solution, 0.1%, 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 DIFFERIN (adapalene) solution, 0.1%, 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: January 24, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-02087 Filed 1-30-13; 8:45 am]
BILLING CODE 4160-01-P