[Federal Register: February 18, 2004 (Volume 69, Number 32)]
[Page 7649-7650]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2004N-0047]

Determination That Chlorthalidone Tablets and Seven Other Drug 
Products Were Not Withdrawn From Sale for Reasons of Safety or 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) has determined that the 
eight drug products listed in this document were not withdrawn from 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 Under FDA regulations, drugs are withdrawn from the 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 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the listed drug was withdrawn from sale for reasons of safety or 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)(1) (21 CFR 314.161(a)(1)), 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 referred to the listed drug have 
been approved. Section 314.161(d) provides that if FDA determines that 
the 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.
    The holders of the applications listed in table 1 of this document 
have informed FDA that the drug products have been withdrawn from sale. 
(As requested by the applicants, FDA withdrew approval of NDA 17-503 
for COMBIPRES and ANDA 60-462 for GARAMYCIN in the Federal Register of 
August 18, 2003 (68 FR 49481)).

                                                     Table 1
            Application No.                             Drug                              Applicant
12-283                                  HYGROTON (chlorthalidone) Tablets,         Aventis Pharmaceuticals, 300
                                                 25 and 50 milligrams (mg)            Somerset Corporate Blvd.,
                                                                                     Bridgewater, NJ 08807-2854
17-503                                  COMBIPRES (clonidine hydrochloride                 Boehringer Ingelheim
                                        (HCl); chlorthalidone) Tablets, 0.1          Pharmaceuticals, Inc., 900
                                        mg/15 mg, 0.2 mg/15 mg and 0.3 mg/         Ridgebury Rd., P.O. Box 368,
                                                                     15 mg            Ridgefield, CT 06877-0368

[[Page 7650]]

17-884                                                              CHRONULAC (lactAventis Pharmaceuticals, Inc
                                          Solution, 10 grams/15 milliliter
18-581                                  SODIUM NITROPRUSSIDE Injection, 50    Elkins-Sinn, Inc., Two Esterbrook
                                                                   mg/vial                                     Lane, Cherry Hill, NJ 08003-4099
20-058                                                               THIOPLEX Immunex Corp., 51 University St.,
                                                                   mg/vial               Seattle, WA 98101-2936
50-621                                  SUPRAX (cefixime) Tablets, 200 and                                     Lederle Laboratories, P.O. Box
                                                                    400 mg    8299, Philadelphia, PA 19101-8299
50-622                                   SUPRAX (cefixime) Powder for Oral                                   Do
                                                    Suspension, 100 mg/5 mL
60-462                                      GARAMYCIN (gentamycin sulfate)   Schering Corp., 2000 Galloping Hill
                                                Topical Cream, 0.1 percent            Rd., Kenilworth, NJ 07033

    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 withdrawal of the products subject to those NDAs and 
ANDA. Additional ANDAs for the products may also be approved by the 

    Dated: February 9, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-3414 Filed 2-17-04; 8:45 am]