[Federal Register Volume 78, Number 160 (Monday, August 19, 2013)]
[Notices]
[Pages 50420-50421]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-20086]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0924]


Determination That LIDEX (fluocinonide) Cream and LIDEX-E 
(fluocinonide) Cream and Nine Other Drug Products Were Not Withdrawn 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 the 
drug products listed in this document were not withdrawn from sale for 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 continue to approve ANDAs that refer to the products as 
long as they meet relevant legal and regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Mark Geanacopoulos, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6206, Silver Spring, MD 20993-0002, 301-
796-6925.

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 
sponsors 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. Sponsors of ANDAs 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

[[Page 50421]]

publish a list of all approved drugs. FDA publishes this list as part 
of the ``Approved Drug Products With Therapeutic Equivalence 
Evaluations,'' which is generally known as the ``Orange Book.'' Under 
FDA regulations, a drug is 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) (21 CFR 314.161(a)), the Agency must 
determine whether a listed drug was withdrawn from sale for reasons of 
safety or effectiveness: (1) Before an ANDA that refers to that listed 
drug may be approved; (2) whenever a listed drug is voluntarily 
withdrawn from sale and ANDAs that refer to the listed drug have been 
approved; and (3) when a person petitions for such a determination 
under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if 
FDA determines that a listed drug was withdrawn from sale for safety or 
effectiveness reasons, the Agency will initiate proceedings that could 
result in the withdrawal of approval of the ANDAs that refer to the 
listed drug.
    FDA has become aware that the drug products listed in the table in 
this document are no longer being marketed.

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          Application No.                             Drug                                Applicant
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NDA 016908.........................  LIDEX (fluocinonide) Cream; Topical,   Medicis Pharmaceutical Corp., 7720
                                      0.05%,.                                North Dobson Rd., Scottsdale, AZ
                                                                             85256.
Do.................................  LIDEX-E (fluocinonide) Cream;          Do.
                                      Topical, 0.05%.
NDA 018181.........................  MYCELEX (clotrimazole) Solution;       Bayer Health Care, 100 Bayer Rd.,
                                      Topical, 1%.                           Pittsburgh, PA 15205.
NDA 018713.........................  MYCELEX (clotrimazole) Lozenge; Oral,  Do.
                                      10 milligrans (mg).
NDA 019510.........................  PEPCID (famotidine) Injection, 10 mg/  Merck Research Laboratories, Inc.,
                                      milliliter (mL).                       770 Sumneytown Pike, West Point, PA
                                                                             19486.
Do.................................  PEPCID PRESERVATIVE FREE (famotidine)  Do.
                                      Injection, 10 mg/mL.
NDA 020249.........................  PEPCID PRESERVATIVE FREE IN PLASTIC    Do.
                                      CONTAINER (famotidine) Injection,
                                      0.4 mg/mL.
NDA 021065.........................  FEMHRT (ethinyl estradiol;             Warner Chilcott LLC, 1 Grand Canal
                                      norethindrone acetate) Tablet; Oral,   Sq., Docklands, Dublin 2, Ireland.
                                      0.005 mg/1 mg.
NDA 050763.........................  MITOZYTREX (mitomycin) Injection, 5    SuperGen, Inc., 4140 Dublin Blvd.,
                                      mg/vial.                               Suite 200, Dublin, CA 94568.
ANDA 086031........................  ISOSORBIDE DINITRATE (isosorbide       Watson Laboratories, 577 Chipeta
                                      dinitrate) Tablet; Sublingual, 5 mg.   Way, Salt Lake City, UT 84108.
ANDA 086033........................  ISOSORBIDE DINITRATE (isosorbide       Do.
                                      dinitrate) Tablet; Sublingual, 2.5
                                      mg.
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    FDA has reviewed its records and, under Sec.  314.161, has 
determined that the drug products listed in this document were not 
withdrawn from sale for reasons of safety or effectiveness. 
Accordingly, the Agency will continue to list the drug products listed 
in this document in the ``Discontinued Drug Product List'' section of 
the Orange Book. The ``Discontinued Drug Product List'' identifies, 
among other items, drug products that have been discontinued from 
marketing for reasons other than safety or effectiveness.
    Approved ANDAs that refer to the NDAs and ANDAs listed in this 
document are unaffected by the discontinued marketing of the products 
subject to those NDAs and ANDAs. Additional ANDAs that refer to these 
products may also be approved by the Agency if they comply with 
relevant legal and regulatory requirements. If FDA determines that 
labeling for these drug products should be revised to meet current 
standards, the Agency will advise ANDA applicants to submit such 
labeling.

    Dated: August 13, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-20086 Filed 8-16-13; 8:45 am]
BILLING CODE 4160-01-P