[Federal Register Volume 74, Number 157 (Monday, August 17, 2009)]
[Notices]
[Pages 41437-41438]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-19641]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-P-0443]


Determination That DEMADEX (Torsemide) Injection, 20 Milligrams/2 
Milliliter (10 Milligrams/Milliliter) and 50 Milligrams/5 Milliliter 
(10 Milligrams/Milliliter), Was Not Withdrawn From Sale for Reasons of 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) is announcing its 
determination that DEMADEX (torsemide) injection, 20 milligrams (mg)/2 
milliliter (mL) (10 mg/mL) and 50 mg/5 mL (10 mg/mL), was not withdrawn 
from sale for reasons of safety or effectiveness. This determination 
will allow FDA to approve abbreviated new drug applications (ANDAs) for 
torsemide injection, 20 mg/2mL (10 mg/mL) and 50 mg/5 mL (10 mg/mL), if 
all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Nikki Mueller, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6312, 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 
applicants 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. ANDA applicants 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 (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 known generally as the ``Orange 
Book.'' Under FDA regulations, drugs are removed 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 before an 
ANDA that refers to that listed drug may be approved. FDA may not 
approve an ANDA that does not refer to a listed drug.
    PharmaForce, Inc., submitted a citizen petition dated August 5, 
2008 (Docket No. FDA-2008-P-0443), under 21 CFR 10.30 requesting that 
the agency determine whether DEMADEX (torsemide) injection, 20 mg/2 mL 
(10 mg/mL) and 50 mg/5 mL (10 mg/mL), was withdrawn from sale for 
reasons of safety or effectiveness. DEMADEX (torsemide) injection is 
the subject of NDA 20-137, held by Roche Pharmaceuticals (Roche) and 
was initially approved on August 23, 1993. DEMADEX is indicated for the 
treatment of edema associated with congestive heart failure, renal 
disease, or hepatic disease. Roche notified FDA on June 16, 2008, that 
it was no longer marketing DEMADEX (torsemide) injection, 20 mg/2 mL 
(10 mg/mL) and 50 mg/5 mL (10 mg/mL), and the drug product was moved to 
the ``Discontinued Drug Product List'' section of the Orange Book.
    FDA has reviewed its records and, under Sec.  314.161, has 
determined that DEMADEX (torsemide) injection, 20 mg/2 mL (10 mg/mL) 
and 50 mg/5 mL (10

[[Page 41438]]

mg/mL), was not withdrawn from sale for reasons of safety or 
effectiveness. The petitioner identified no data or other information 
suggesting that DEMADEX (torsemide) injection, 20 mg/2 mL (10 mg/mL) 
and 50 mg/5 mL (10 mg/mL), was withdrawn for reasons of safety or 
effectiveness. FDA has independently evaluated relevant literature and 
data for possible postmarketing adverse events and has found no 
information that would indicate that this product was withdrawn from 
sale for reasons of safety or effectiveness. Accordingly, the agency 
will continue to list DEMADEX (torsemide) injection, 20 mg/2 mL (10 mg/
mL) and 50 mg/5 mL (10 mg/mL), 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 DEMADEX (torsemide) injection, 20 
mg/2 mL (10 mg/mL) and 50 mg/5 mL (10 mg/mL), may be approved by the 
agency if all other legal and regulatory requirements for the approval 
of ANDAs are met. If FDA determines that labeling for this drug product 
should be revised to meet current standards, the agency will advise 
ANDA applicants to submit such labeling.

    Dated: August 7, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-19641 Filed 8-14-09; 8:45 am]
BILLING CODE 4160-01-S