[Federal Register Volume 73, Number 82 (Monday, April 28, 2008)]
[Notices]
[Pages 22960-22961]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-9161]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0238]
Determination That TAPAZOLE Tablets and 18 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Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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
19 drug products listed in this document were not withdrawn from sale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 the 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 A. Pritzlaff, Center for Drug
Evaluation and Research (HFD-7), 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 Under FDA regulations, drugs are withdrawn from the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 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 7-517 for TAPAZOLE Tablets in
the Federal Register of November 7, 2007 (72 FR 62858), NDA 18-754 for
ORUDIS Capsules in the Federal Register of June 16, 2006 (71 FR 34940),
NDA 18-062 for PROVENTIL Syrup in the Federal Register of March 4, 2005
(70 FR 10651), and NDA 8-604 for PHENERGAN VC Syrup in the Federal
Register of May 5, 2004 (69 FR 25124).
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NDA No. Drug Applicant
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7-517 TAPAZOLE (methimazole) King Pharmaceuticals, Inc.,
Tablets, 5 milligrams (mg) 501 Fifth St., Bristol, TN
and 10 mg 37620
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7-935 PHENERGAN (promethazine Wyeth Pharmaceuticals,Inc.,
hydrochloride (HCl)) P.O. Box 8299,
Tablets, 25 mg Philadelphia, PA 19101-
8299
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8-306 PHENERGAN with Codeine ANI Pharmaceuticals, Inc.,
(codeine phosphate and 7131 Ambassador Rd.,
promethazine HCl) Syrup, Woodlawn, MD 21244
6.25 mg/5 milliliters
(mL), 10 mg/5 mL
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[[Page 22961]]
8-306 PHENERGAN VC with Codeine Do.
(codeine phosphate;
phenylephrine HCl;
promethazine HCl) Syrup, 5
mg/5 mL; 6.25 mg/5 mL; 10
mg/5 mL
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8-381 PHENERGAN FORTIS Do.
(promethazine HCl) Syrup,
25 mg/5 mL
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8-381 PHENERGAN Plain Do.
(promethazine HCl) Syrup,
6.25 mg/5 mL
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8-604 PHENERGAN VC (phenylephrine Do.
HCl; promethazine HCl)
Syrup, 5 mg/5 mL; 6.25 mg/
5 mL
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9-000 CAFERGOT (caffeine; Novartis Pharmaceuticals
ergotamine tartrate) Corp., One Health Plaza,
Suppository, 100 mg/2 mg East Hanover, NJ 07936-
1080
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9-509 ARAMINE (metaraminol Merck & Co., Inc., 770
bitartrate) Injection, Sumneytown Pike, BLA-20,
equivalent to (EQ) 10 mg P.O. Box 4, West Point, PA
base/mL 19486
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11-265 PHENERGAN with ANI
Dextromethorphan
(dextromethorphan
hydrobromide; promethazine
HCl) Syrup, 6.25 mg/5 mL;
15 mg/5 mL
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11-459 VISTARIL (hydroxyzine Pfizer, Inc., 235 East
pamoate EQ hydroxyzine 42\nd\ St., New York, NY
HCl) Capsules, 100 mg 10017
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11-689 PHENERGAN (promethazine Wyeth
HCl) Suppository, 50 mg
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12-125 CARBOCAINE (mepivacaine Eastman Kodak Co., Dental
HCl) Injection, 3 % (30 mg/ Products, 343 State St.,
mL/1.8 mL cartridge) Rochester, NY 14612-1122
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18-062 PROVENTIL (albuterol Schering Corp., 2000
sulfate) Syrup, EQ 2 mg Galloping Hill Rd.,
base/5mL Kenilworth, NJ 07033
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18-152 ESKALITH CR (lithium GlaxoSmithKline, One
carbonate) Extended Franklin Plaza, P.O. Box
Release Tablets, 450 mg 7929, Philadelphia, PA
19101-7929
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18-200 MIDAMOR (amiloride HCl) Merck
Tablets, 5 mg
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18-201 MODURETIC 5-50 (amiloride Merck
HCl; hydrochlorothiazide)
Tablets, 5 mg/50 mg
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18-754 ORUDIS (ketoprofen) Wyeth
Capsules, 25 mg, 50 mg,
and 75 mg
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20-460 CYTOVENE (ganciclovir) Roche Laboratories, Inc.,
Capsules, 250 mg and 500 340 Kingsland St., Nutley,
mg NJ 07110-1199
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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 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: April 18, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-9161 Filed 4-25-08; 8:45 am]
BILLING CODE 4160-01-S