[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Products Were Not Withdrawn From Sale for Reasons of Safety or 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27 drug products listed in this document were not withdrawn from sale 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 Under FDA regulations, drugs are withdrawn from the 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)).

------------------------------------------------------------------------
 Application No.             Drug                      Applicant
------------------------------------------------------------------------
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
------------------------------------------------------------------------
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
------------------------------------------------------------------------
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
------------------------------------------------------------------------
NDA 9-149         THORAZINE (chlorpromazine   GlaxoSmithKline, 2301
                   HCl) Tablets, 10, 25, 50,   Renaissance Blvd., King
                   100, and 200 mg             of Prussia, PA 19406
------------------------------------------------------------------------
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
------------------------------------------------------------------------
NDA 11-664        DECADRON (dexamethasone)    Do.
                   Tablets, 0.25, 4, and 6
                   mg
------------------------------------------------------------------------
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
------------------------------------------------------------------------
NDA 11-870        DIURIL (chlorothiazide)     Merck & Co., Inc.
                   Suspension, 250 mg/5 mL
------------------------------------------------------------------------
NDA 13-400        ALDOMET (methyldopa)        Do.
                   Tablets, 125, 250, and
                   500 mg
------------------------------------------------------------------------
NDA 13-401        ALDOMET (methyldopate HCl)  Do.
                   Injection, 50 mg/mL
------------------------------------------------------------------------
NDA 16-363        LASIX (furosemide)          Aventis Pharmaceuticals,
                   Injection, 10 mg/mL         Inc., 200 Crossing Blvd.,
                                               Bridgewater, NJ 08807-
                                               0890
------------------------------------------------------------------------
NDA 17-391        IMURAN (azathioprine)       Prometheus Laboratories,
                   Injection, 100 mg base/     5739 Pacific Center
                   vial                        Blvd., San Diego, CA
                                               92121-4203
------------------------------------------------------------------------
NDA 17-939        TAGAMET (cimetidine HCl)    GlaxoSmithKline
                   Injection, 300 mg/2 mL
------------------------------------------------------------------------
NDA 18-513        CHENIX (chenodiol)          Axcan Scandipharm, Inc.,
                   Tablets, 250 mg             22 Inverness Center
                                               Parkway, Birmingham, AL
                                               35242-4814
------------------------------------------------------------------------
NDA 18-675        TAVIST (clemastine          Novartis Consumer Health,
                   fumarate) Oral Syrup, 0.5   Inc., 200 Kimball Dr.,
                   mg/5 mL                     Parsippany, NJ 07054-0622
------------------------------------------------------------------------
NDA 18-922        LODINE (etodolac)           Wyeth Pharmaceuticals,
                   Capsules, 200 mg; LODINE    Inc.
                   Tablets, 400 mg and 500
                   mg
------------------------------------------------------------------------
NDA 19-201        VOLTAREN (diclofenac        Novartis Pharmaceuticals,
                   sodium) Delayed-Release     Inc.
                   Tablets, 25 mg and 50 mg
------------------------------------------------------------------------
NDA 19-243        PROVENTIL (albuterol        Schering-Plough
                   sulfate) Inhalation         Corporation, 2000
                   Solution, 0.5% and 0.083%   Galloping Hill Rd.,
                                               Kenilworth, NJ 07033
------------------------------------------------------------------------
NDA 19-434        TAGAMET HCl (cimetidine     GlaxoSmithKline
                   HCl) in Sodium Chloride
                   0.9% in Plastic
                   Container, EQ 6 mg/mL
------------------------------------------------------------------------
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
------------------------------------------------------------------------
NDA 19-817        PERSANTINE (dipyridamole)   Boehringer Ingelheim
                   Injection, 5 mg/mL          Pharmaceuticals, Inc.,
                                               900 Ridgebury Rd., P.O.
                                               Box 368, Ridgefield, CT
                                               06877-0368
------------------------------------------------------------------------

[[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
------------------------------------------------------------------------
NDA 20-584        LODINE (etodolac) XL        Wyeth Pharmaceuticals,
                   Tablets, 600 mg             Inc.
------------------------------------------------------------------------
NDA 21-110        RAPAMUNE (sirolimus)        Wyeth Pharmaceuticals,
                   Tablets, 5 mg               Inc.
------------------------------------------------------------------------
NDA 50-477        NEBCIN (tobramycin          Eli Lilly and Co.
                   sulfate) Injection, 10 mg/
                   mL
------------------------------------------------------------------------
NDA 50-519        NEBCIN (tobramycin          Do.
                   sulfate) Injection, 1.2
                   grams/vial
------------------------------------------------------------------------
ANDA 62-008       NEBCIN (tobramycin          Do.
                   sulfate) Injection, 40 mg/
                   mL
------------------------------------------------------------------------

    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