[Federal Register: November 7, 2002 (Volume 67, Number 216)]
[Page 67858-67859]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 01P-0350]

Determination That Sodium Tetradecyl Sulfate Injection Was Not 
Withdrawn From Sale for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) has determined that 
sodium tetradecyl sulfate injection (Sotradecol) was not withdrawn from 
sale for reasons of safety or effectiveness. This determination will 
allow FDA to approve abbreviated new

[[Page 67859]]

drug applications (ANDAs) for sodium tetradecyl sulfate injection.

FOR FURTHER INFORMATION CONTACT: J. Kenneth Borgerding, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 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 under a new drug 
application (NDA). Sponsors of ANDAs do not have to repeat the 
extensive clinical testing otherwise necessary to gain approval of an 
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 
    The 1984 amendments include what is now section 505(j)(7) of the 
Federal Food, Drug, and Cosmetic 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 Under FDA regulations, drugs are withdrawn from the list if the 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drug was withdrawn from sale for reasons of safety or effectiveness (21 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). Regulations also provide that the agency must make a 
determination as to whether a listed drug was withdrawn from sale for 
reasons of safety or effectiveness, before an ANDA that refers to that 
listed drug may be approved (21 CFR 314.161(a)(1)). FDA may not approve 
an ANDA that does not refer to a listed drug.
    Sodium tetradecyl sulfate injection is the subject of NDA 5-970. On 
August 13, 1946, Elkins Sinn received approval to market sodium 
tetradecyl sulfate injection. During 2000, Elkins Sinn discontinued 
manufacture of this product.
    On August 13, 2001, Bennett and Company submitted a citizen 
petition (Docket No. 01P-0350/CP1) under Sec.  10.30 (21 CFR 10.30) to 
FDA requesting that the agency determine whether sodium tetradecyl 
sulfate injection was withdrawn from sale for reasons of safety or 
effectiveness. In addition, on December 6, 2001, Omega Laboratories, 
Ltd., submitted a citizen petition (Docket No. 01P-0350/CP2) under 
Sec.  10.30 to FDA making the same request. FDA has reviewed its 
records and has found no information to indicate that sodium tetradecyl 
sulfate injection was withdrawn from the market for safety or efficacy 
reasons. Therefore, FDA concludes that the decision to not manufacture 
and market the product was not due to safety or efficacy concerns. 
Accordingly, the agency will maintain sodium tetradecyl sulfate 
injection in the ``Discontinued Drug Product List'' section of the 
Orange Book. The ``Discontinued Drug Product List'' delineates, among 
other items, drug products that have been discontinued from marketing 
for reasons other than safety or effectiveness. ANDAs that refer to 
sodium tetradecyl sulfate injection may be approved by the agency.

    Dated: October 28, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-28400 Filed 11-6-02; 8:45 am]