Document ID: FDA-2009-P-0218-0004
Agency: fda
Document Type: Notice
Title: Drug Products Not Withdrawn from Sale for Reasons of Safety or Effectiveness; Determinations: DECA-DURABOLIN (Nandrolone Decanoate) Injection, 200 Milligrams/Milliliter, 1 Milliliter
Posted Date: 2010-08-10T04:00Z

[Federal Register: August 10, 2010 (Volume 75, Number 153)]
[Notices]               
[Page 48351-48352]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10au10-58]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-P-0218]

 
Determination That DECA-DURABOLIN (Nandrolone Decanoate) 
Injection, 200 Milligrams/Milliliter, 1 Milliliter, Was Not Withdrawn 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 DECA-DURABOLIN (nandrolone decanoate) Injection, 200 
milligrams/milliliter (mg/mL), 1 mL, was not withdrawn from sale for 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 nandrolone 
decanoate, 200 mg/mL, 1 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 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.
    DECA-DURABOLIN (nandrolone decanoate) Injection is the subject of 
NDA 13-132, held by Organon, Inc.

[[Page 48352]]

(Organon), and was initially approved on October 5, 1962. Under the 
Drug Efficacy Study Implementation (DESI), FDA concluded that 
nandrolone decanoate was effective for the indications described in the 
Federal Register notice published on July 15, 1983 (DESI 7630, 48 FR 
32394). DECA-DURABOLIN is an anabolic steroid indicated for the 
management of the anemia of renal insufficiency and has been shown to 
increase hemoglobin and red cell mass. Organon notified FDA in a letter 
dated May 21, 2002, that it was no longer marketing DECA-DURABOLIN 
(nandrolone decanoate) Injection, 200 mg/mL, 1 mL, and the drug product 
was moved to the ``Discontinued Drug Product List'' section of the 
Orange Book. PharmaForce, Inc., submitted a citizen petition dated May 
7, 2009 (Docket No. FDA-2009-P-0218), under 21 CFR 10.30 requesting 
that the agency determine whether DECA-DURABOLIN (nandrolone decanoate) 
Injection, 200 mg/mL, 1 mL, was withdrawn from sale for reasons of 
safety or effectiveness.
    FDA has reviewed its records and, under Sec.  314.161, has 
determined that DECA-DURABOLIN (nandrolone decanoate) Injection, 200 
mg/mL, 1 mL, was not withdrawn from sale for reasons of safety or 
effectiveness. The petitioner identified no data or other information 
suggesting that DECA-DURABOLIN (nandrolone decanoate) Injection, 200 
mg/mL, 1 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 
DECA-DURABOLIN (nandrolone decanoate) Injection, 200 mg/mL, 1 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 DECA-DURABOLIN 
(nandrolone decanoate) Injection, 200 mg/mL, 1 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 5, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-19698 Filed 8-9-10; 8:45 am]
BILLING CODE 4160-01-S