[Federal Register Volume 72, Number 99 (Wednesday, May 23, 2007)]
[Notices]
[Pages 28982-28984]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-9962]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0191]
Determination That Protamine Sulfate Injection and 26 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Products Were Not Withdrawn From Sale for Reasons of Safety or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
27 drug products listed in this document were not withdrawn from sale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) for the drug products, and it will allow FDA
to continue to approve ANDAs for the products.
FOR FURTHER INFORMATION CONTACT: Mary Catchings, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20855, 301-594-2041.
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 Under FDA regulations, drugs are withdrawn from the
list if the agency withdraws or suspends approval
[[Page 28983]]
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 or (2) whenever a listed drug is voluntarily
withdrawn from sale, and ANDAs that refer to the listed drug have been
approved. Section 314.161(d) provides that if FDA determines that a
listed drug was removed 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
applicants, FDA withdrew approval of NDA 6-460 for Protamine Sulfate
Injection, NDA 18-675 for TAVIST Syrup, NDA 19-243 for PROVENTIL
Inhalation Solution, NDA 19-471 for CARDIZEM SR Capsules, and NDA 19-
817 for PERSANTINE Injection in the Federal Register of March 4, 2005
(70 FR 10651), NDA 8-857 for PHENERGAN Injection in the Federal
Register of May 5, 2004 (69 FR 25124), and NDA 13-400 for ALDOMET
Tablets and NDA 13-401 for ALDOMET Injection in the Federal Register of
June 16, 2006 (71 FR 34940)).
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Application No. Drug Applicant
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NDA 6-460 Protamine Sulfate Eli Lilly and Co., Lilly
Injection, 10 milligrams Corporate Center,
(mg)/milliliter (mL) in a Indianapolis, IN 46285
25-mL vial
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NDA 6-773 ARTANE (trihexyphenidyl Lederle, c/o Wyeth
hydrochloride (HCl)) Pharmaceuticals, P.O. Box
Tablets, 2 mg and 5 mg 8299, Philadelphia, PA
19101-8299
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NDA 8-857 PHENERGAN (promethazine Wyeth Pharmaceuticals,
HCl) Injection, 25 mg/mL P.O. Box 8299,
and 50 mg/mL in 1-mL Philadelphia, PA 19101-
vials 8299
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NDA 9-149 THORAZINE (chlorpromazine GlaxoSmithKline, 2301
HCl) Tablets, 10, 25, 50, Renaissance Blvd., King
100, and 200 mg of Prussia, PA 19406
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NDA 11-145 DIURIL (chlorothiazide) Merck & Co., Inc.,
Tablets, 250 mg and 500 Sumneytown Pike, BLA-20,
mg P.O. Box 4, West Point,
PA 19486
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NDA 11-664 DECADRON (dexamethasone) Do.
Tablets, 0.25, 4, and 6
mg
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NDA 11-808 MELLARIL (thioridazine Novartis Pharmaceuticals
HCl) Tablets, 10, 15, 25, Corp., One Health Plaza,
50, 100, 150, and 200 mg East Hanover, NJ 07936
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NDA 11-870 DIURIL (chlorothiazide) Merck & Co., Inc.
Suspension, 250 mg/5 mL
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NDA 13-400 ALDOMET (methyldopa) Do.
Tablets, 125, 250, and
500 mg
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NDA 13-401 ALDOMET (methyldopate HCl) Do.
Injection, 50 mg/mL
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NDA 16-363 LASIX (furosemide) Aventis Pharmaceuticals,
Injection, 10 mg/mL Inc., 200 Crossing Blvd.,
Bridgewater, NJ 08807-
0890
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NDA 17-391 IMURAN (azathioprine) Prometheus Laboratories,
Injection, 100 mg base/ 5739 Pacific Center
vial Blvd., San Diego, CA
92121-4203
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NDA 17-939 TAGAMET (cimetidine HCl) GlaxoSmithKline
Injection, 300 mg/2 mL
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NDA 18-513 CHENIX (chenodiol) Axcan Scandipharm, Inc.,
Tablets, 250 mg 22 Inverness Center
Parkway, Birmingham, AL
35242-4814
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NDA 18-675 TAVIST (clemastine Novartis Consumer Health,
fumarate) Oral Syrup, 0.5 Inc., 200 Kimball Dr.,
mg/5 mL Parsippany, NJ 07054-0622
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NDA 18-922 LODINE (etodolac) Wyeth Pharmaceuticals,
Capsules, 200 mg; LODINE Inc.
Tablets, 400 mg and 500
mg
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NDA 19-201 VOLTAREN (diclofenac Novartis Pharmaceuticals,
sodium) Delayed-Release Inc.
Tablets, 25 mg and 50 mg
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NDA 19-243 PROVENTIL (albuterol Schering-Plough
sulfate) Inhalation Corporation, 2000
Solution, 0.5% and 0.083% Galloping Hill Rd.,
Kenilworth, NJ 07033
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NDA 19-434 TAGAMET HCl (cimetidine GlaxoSmithKline
HCl) in Sodium Chloride
0.9% in Plastic
Container, EQ 6 mg/mL
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NDA 19-471 CARDIZEM SR (diltiazem Biovail Laboratories,
HCl) Capsules, 60, 90, Inc., c/o Bioavail
120, and 180 mg Technologies Ltd., 700
Route 202/206 North,
Bridgewater, NJ 08807-
0980
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NDA 19-817 PERSANTINE (dipyridamole) Boehringer Ingelheim
Injection, 5 mg/mL Pharmaceuticals, Inc.,
900 Ridgebury Rd., P.O.
Box 368, Ridgefield, CT
06877-0368
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[[Page 28984]]
NDA 20-144 TRANSDERM-NITRO Novartis Pharmaceuticals
(nitroglycerin), 0.1 mg/ Corp.
hour (hr), 0.2 mg/hr,
0.4 mg/hr, 0.6 mg/hr, 0.8
mg/hr
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NDA 20-584 LODINE (etodolac) XL Wyeth Pharmaceuticals,
Tablets, 600 mg Inc.
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NDA 21-110 RAPAMUNE (sirolimus) Wyeth Pharmaceuticals,
Tablets, 5 mg Inc.
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NDA 50-477 NEBCIN (tobramycin Eli Lilly and Co.
sulfate) Injection, 10 mg/
mL
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NDA 50-519 NEBCIN (tobramycin Do.
sulfate) Injection, 1.2
grams/vial
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ANDA 62-008 NEBCIN (tobramycin Do.
sulfate) Injection, 40 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 ANDA listed in this document are
unaffected by the discontinued marketing of the products subject to
those NDAs and ANDA. Additional ANDAs for the 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 15, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-9962 Filed 5-22-07; 8:45 am]
BILLING CODE 4160-01-S