[Federal Register: May 14, 2009 (Volume 74, Number 92)]
[Notices]
[Page 22751-22752]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14my09-44]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0188]
Determination That DECADRON Tablets 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Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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
10 drug products listed in this document were not withdrawn from sale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: Olivia Pritzlaff, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6308, Silver Spring, MD 20993-0002, 301-
796-3601.
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Public Law 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 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 (the 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 Under FDA regulations, a drug is withdrawn from the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 reasons
of safety or effectiveness, 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 18-821 for REGLAN
(metoclopramide) Oral Solution in the Federal Register of October 10,
2002 (67 FR 63107).)
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Application No. Drug Applicant
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NDA 11-664 DECADRON Merck & Co., P.O. Box
(dexamethasone) 4, BLA-20, West
Tablets, 0.5 milligram Point, PA 19486
(mg) and 0.75 mg
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NDA 15-229 AMICAR (aminocaproic Xanodyne
acid) Injection, 250 Pharmaceuticals,
mg/milliliter (mL) Inc., One Riverfront
Pl., Newport, KY
41071-4563
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[[Page 22752]]
NDA 16-636 NARCAN (naloxone Endo Pharmaceuticals,
hydrocholoride (HCl)) Inc., 100 Painters
Injection, 0.02 mg/mL, Dr., Chadds Ford, PA
0.4 mg/mL, and 1 mg/mL 19317
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NDA 16-929 FUDR (floxuridine) Hospira, Inc., 275
Injection, 500 mg/vial North Field Dr., Lake
Forest, IL 60045
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NDA 18-538 LOZOL (indapamide) Sanofi-Aventis U.S.,
Tablets, 1.25 mg and 55 Corporate Blvd.,
2.5 mg P.O. Box 5925,
Bridgewater, NJ 08807
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NDA 18-821 REGLAN (metaclopramide A.H. Robins Co., c/o
HCl) Oral Solution, Wyeth-Ayerst
equivalent to (EQ) 5 Research, P.O. Box
mg base/5 mL 8299, Philadelphia,
PA 19101-8299
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NDA 18-831 TRACRIUM (atracurium Hospira, Inc.
besylate) Injection,
10 mg/mL
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NDA 18-831 TRACRIUM (atracurium Do.
besylate) Preservative
Free Injection, 10 mg/
mL
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NDA 19-080 PROSOM (estazolam) Abbott Laboratories,
Tablets, 1 mg and 2 mg 200 Abbott Park Rd.,
D-491, AP30-1E,
Abbott Park, IL 60064-
6157
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NDA 20-397 ZANAFLEX (tizanidine Acorda Therapeutics,
HCL) Tablets, EQ 2 mg 15 Skyline Dr.,
base Hawthorne, NY 10532
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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 listed in this document are
unaffected by the discontinued marketing of the products subject to
those NDAs. 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: May 6, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-11217 Filed 5-13-09; 8:45 am]
BILLING CODE 4160-01-S