[Federal Register Volume 75, Number 153 (Tuesday, August 10, 2010)]
[Notices]
[Pages 48351-48352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-19698]
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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Injection, 200 Milligrams/Milliliter, 1 Milliliter, Was Not Withdrawn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milligrams/milliliter (mg/mL), 1 mL, was not withdrawn from sale for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