[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(fluocinonide) Cream and Nine Other Drug Products Were Not Withdrawn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drug products listed in this document were not withdrawn from sale for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