[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Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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19 drug products listed in this document were not withdrawn from sale 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).

------------------------------------------------------------------------
    NDA No.                 Drug                      Applicant
------------------------------------------------------------------------
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
------------------------------------------------------------------------
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
------------------------------------------------------------------------

[[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
------------------------------------------------------------------------
8-381           PHENERGAN FORTIS             Do.
                 (promethazine HCl) Syrup,
                 25 mg/5 mL
------------------------------------------------------------------------
8-381           PHENERGAN Plain              Do.
                 (promethazine HCl) Syrup,
                 6.25 mg/5 mL
------------------------------------------------------------------------
8-604           PHENERGAN VC (phenylephrine  Do.
                 HCl; promethazine HCl)
                 Syrup, 5 mg/5 mL; 6.25 mg/
                 5 mL
------------------------------------------------------------------------
9-000           CAFERGOT (caffeine;          Novartis Pharmaceuticals
                 ergotamine tartrate)         Corp., One Health Plaza,
                 Suppository, 100 mg/2 mg     East Hanover, NJ 07936-
                                              1080
------------------------------------------------------------------------
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
------------------------------------------------------------------------
11-265          PHENERGAN with               ANI
                 Dextromethorphan
                 (dextromethorphan
                 hydrobromide; promethazine
                 HCl) Syrup, 6.25 mg/5 mL;
                 15 mg/5 mL
------------------------------------------------------------------------
11-459          VISTARIL (hydroxyzine        Pfizer, Inc., 235 East
                 pamoate EQ hydroxyzine       42\nd\ St., New York, NY
                 HCl) Capsules, 100 mg        10017
------------------------------------------------------------------------
11-689          PHENERGAN (promethazine      Wyeth
                 HCl) Suppository, 50 mg
------------------------------------------------------------------------
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
------------------------------------------------------------------------
18-062          PROVENTIL (albuterol         Schering Corp., 2000
                 sulfate) Syrup, EQ 2 mg      Galloping Hill Rd.,
                 base/5mL                     Kenilworth, NJ 07033
------------------------------------------------------------------------
18-152          ESKALITH CR (lithium         GlaxoSmithKline, One
                 carbonate) Extended          Franklin Plaza, P.O. Box
                 Release Tablets, 450 mg      7929, Philadelphia, PA
                                              19101-7929
------------------------------------------------------------------------
18-200          MIDAMOR (amiloride HCl)      Merck
                 Tablets, 5 mg
------------------------------------------------------------------------
18-201          MODURETIC 5-50 (amiloride    Merck
                 HCl; hydrochlorothiazide)
                 Tablets, 5 mg/50 mg
------------------------------------------------------------------------
18-754          ORUDIS (ketoprofen)          Wyeth
                 Capsules, 25 mg, 50 mg,
                 and 75 mg
------------------------------------------------------------------------
20-460          CYTOVENE (ganciclovir)       Roche Laboratories, Inc.,
                 Capsules, 250 mg and 500     340 Kingsland St., Nutley,
                 mg                           NJ 07110-1199
------------------------------------------------------------------------

    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