[Federal Register: February 18, 2004 (Volume 69, Number 32)]
[Notices]
[Page 7649-7650]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18fe04-54]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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Products Were Not Withdrawn From Sale for Reasons of Safety or
Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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eight drug products listed in this document were not withdrawn from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 Under FDA regulations, drugs are withdrawn from the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
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Application No. Drug Applicant
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12-283 HYGROTON (chlorthalidone) Tablets, Aventis Pharmaceuticals, 300
25 and 50 milligrams (mg) Somerset Corporate Blvd.,
Bridgewater, NJ 08807-2854
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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
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[[Page 7650]]
17-884 CHRONULAC (lactAventis Pharmaceuticals, Inc
Solution, 10 grams/15 milliliter
(mL)
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18-581 SODIUM NITROPRUSSIDE Injection, 50 Elkins-Sinn, Inc., Two Esterbrook
mg/vial Lane, Cherry Hill, NJ 08003-4099
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20-058 THIOPLEX Immunex Corp., 51 University St.,
mg/vial Seattle, WA 98101-2936
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50-621 SUPRAX (cefixime) Tablets, 200 and Lederle Laboratories, P.O. Box
400 mg 8299, Philadelphia, PA 19101-8299
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50-622 SUPRAX (cefixime) Powder for Oral Do
Suspension, 100 mg/5 mL
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60-462 GARAMYCIN (gentamycin sulfate) Schering Corp., 2000 Galloping Hill
Topical Cream, 0.1 percent Rd., Kenilworth, NJ 07033
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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 withdrawal of the products subject to those NDAs and
ANDA. Additional ANDAs for the products may also be approved by the
agency.
Dated: February 9, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-3414 Filed 2-17-04; 8:45 am]
BILLING CODE 4160-01-S