[Federal Register Volume 79, Number 211 (Friday, October 31, 2014)]
[Notices]
[Page 64807]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-25911]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1577]
Determination That TOPICORT (Desoximetasone) Cream and 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Products Were Not Withdrawn From Sale for Reasons of Safety or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drug products listed in this document were not withdrawn from sale for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: Amy Hopkins, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6223, Silver Spring, MD 20993-0002, 301-
796-5418, [email protected].
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 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 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. (As requested by the
applicant, FDA withdrew approval of NDA 020611 for DOVONEX
(calcipotriene) Solution and NDA 020239 for KYTRIL (granisetron
hydrochloride) in the Federal Register of July 19, 2013 (78 FR 43210)).
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Application No. Drug Applicant
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NDA 017856.................... TOPICORT Taro
(desoximetasone) Pharmaceuticals
Cream; Topical North America
0.25%. Inc., 5 Skyline
Dr., Hawthorne, NY
10532.
NDA 020239.................... KYTRIL (granisetron Hoffmann La Roche
HCl) Injectable; Inc., 340
Injection, Kingsland St.,
Equivalent to (EQ) Nutley, NJ 07110.
0.1 milligram (mg)
Base/milliliter
(mL); EQ 1 mg Base/
mL; EQ 3 mg Base/
mL; EQ 4 mg Base/4
mL.
NDA 020611.................... DOVONEX Leo Pharma Inc., 1
(calcipotriene) Sylvan Way,
Solution; Topical, Parsippany, NJ
0.005%. 07054.
NDA 021275.................... LUMIGAN Allergan Inc., 2525
(bimatoprost) Dupont Dr.,
Solution/Drops; Irvine, CA 92623.
Ophthalmic, 0.03%.
NDA 021864.................... LYBREL (ethinyl Wyeth
estradiol; Pharmaceuticals
levonorgestrel) Inc., P.O. Box
Tablet; Oral, 0.02 8299,
mg/0.09 mg. Philadelphia, PA
19101.
ANDA 075222................... Ketorolac Bedford
Tromethamine Laboratories Inc.,
Injectable; 300 Northfield
Injection, 15 mg/ Rd., Bedford, OH
mL; 30 mg/mL. 44146.
ANDA 075228................... Ketorolac Do.
Tromethamine
Injectable;
Injection, 30 mg/
mL.
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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: October 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-25911 Filed 10-30-14; 8:45 am]
BILLING CODE 4164-01-P