[Federal Register Volume 75, Number 47 (Thursday, March 11, 2010)]
[Notices]
[Pages 11549-11551]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-5275]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0109]
Determination That PRO-BANTHINE (Propantheline Bromide) Tablets
and 14 Other Drug Products Were Not Withdrawn From Sale for Reasons of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the 15 drug products listed in this document were not withdrawn from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).
[[Page 11550]]
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 12-097 for KENALOG IN ORABASE
(triamcinolone acetonide) Dental Paste in the Federal Register of
February 11, 2009 (74 FR 6896).)
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Application No. Drug Applicant
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NDA 8-732 PRO-BANTHINE Shire Pharmaceuticals,
(propantheline Inc.,725 Chesterbrook
bromide) Tablets, 7.5 Blvd., Wayne, PA
milligrams (mg) and 15 19087)
mg
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NDA 12-097 KENALOG IN ORABASE Apothecon, Inc., c/o
(triamcinolone Bristol-Myers Squibb,
acetonide) Dental P.O. Box 4500,
Paste, 0.1% Princeton, NJ 08543-
4500
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NDA 12-141 CYTOXAN Baxter Healthcare
(cyclophosphamide) Corp., 1620 Waukegan
Tablets, 25 mg and 50 Rd. MPGR-AL, McGaw
mg Park, IL 60085
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NDA 17-498 MICRONASE (glyburide) Pharmacia and Upjohn
Tablets, 1.25 mg, 2.5 Co., 7171 Portage
mg, and 5 mg Rd., Kalamazoo, MI
49001
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NDA 17-924 TAGAMET (cimetidine GlaxoSmithKline, 5
HCl) Oral Solution, Moore Dr., P.O. Box
Equivalent to (EQ) 300 13398, Research
mg base/5 mL Triangle Park, NC
27709-3398
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NDA 18-207 DESYREL (trazodone HCl) Apothecon, Inc.
Tablets, 50 mg, 100
mg, 150 mg, and 300 mg
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NDA 19-425 TRANDATE (labetalol Prometheus
HCl) Injection, 5 mg/ Laboratories, Inc.,
mL 9410 Carroll Park
Dr., San Diego, CA
92121
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NDA 20-101 PROZAC (fluoxetine HCl) Eli Lilly and Co.,
Oral Solution, EQ 20 Lilly Corporate
mg base/5 mL Center, Indianapolis,
IN 46285
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NDA 20-286 MONOPRIL-HCT Bristol-Myers Squibb
(fosinopril sodium; Co., P.O. Box 4000,
hydrochlorothiazide) Princeton, NJ 08543-
Tablets, 10 mg/12.5 4000
mg, 20 mg/12.5 mg
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NDA 20-664 DOSTINEX (cabergoline) Pharmacia and Upjohn
Tablet, 0.5 mg Co.
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NDA 20-683 ALESSE (ethinyl Wyeth Pharmaceuticals
estradiol; Inc., P.O. Box 8299,
levonorgestrel) Philadelphia, PA
Tablets (21 Tablets 19101-8299
and 28 Tablets), 0.02
mg; 0.1 mg
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NDA 20-801 PEPCID AC (famotidine) Merck Research
Chewable Tablet, 10 mg Laboratories,
Sumneytown Pike BLA
20, P.O. Box 4, West
Point, PA 19486-0004
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NDA 20-860 LEVLITE (ethinyl Bayer Healthcare
estradiol; Pharmaceuticals,
levonorgestrel) Inc., 340
Tablets (21 Tablets Changebridge Rd.,
and 28 Tablets), 0.02 P.O. Box 1000,
mg; 0.1 mg Montville, NJ 07045-
1000
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NDA 21-455 BONIVA (ibandronate Hoffmann LaRoche,
sodium) Tablet, EQ 2.5 Inc., 340 Kingsland
mg base St., Bldg. 719/4,
Nutley, NJ 07110-1199
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NDA 50-517 MEFOXIN (cefoxitin Merck and Co., Inc.,
sodium) Injection, EQ Sumneytown Pike BLA
1 gram (g) base/vial 20, P.O. Box 4, West
and EQ 2 g base/vial Point, PA 19486-0004
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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.
[[Page 11551]]
Dated: March 8, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-5275 Filed 3-10-10; 8:45 am]
BILLING CODE 4160-01-S