[Federal Register Volume 76, Number 228 (Monday, November 28, 2011)]
[Notices]
[Page 72950]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-30472]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-P-0488]


Determination That TAXOTERE (Docetaxel) Injection, 40 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Milliliter Was Not Withdrawn From Sale for Reasons of Safety or 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) has determined that 
TAXOTERE (docetaxel) Injection, 40 milligrams/milliliter (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not withdrawn from sale for reasons of safety or effectiveness.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 docetaxel injection, 40 mg/mL, if all other 
legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Nam Kim, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, rm. 6320, Silver Spring, MD 20993-0002, (301) 796-3472.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) 
(the 1984 amendments), which authorized the approval of duplicate 
versions of drug products 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).
    A person may petition the Agency to determine, or the Agency may 
determine on its own initiative, whether a listed drug was withdrawn 
from sale for reasons of safety or effectiveness. This determination 
may be made at any time after the drug has been withdrawn from sale, 
but must be made prior to approving an ANDA that refers to the listed 
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that 
does not refer to a listed drug.
    TAXOTERE (docetaxel) Injection, 40 mg/mL is the subject of NDA 20-
449, held by Sanofi-aventis U.S., and initially approved on May 14, 
1996. TAXOTERE is indicated for breast cancer, non-small cell lung 
cancer, hormone refractory prostate cancer, gastric adenocarcinoma, and 
squamous cell carcinoma of the head and neck cancer as described in 
detail on the drug product's labeling.
    TAXOTERE (docetaxel) Injection, 40 mg/mL, is currently listed in 
the ``Discontinued Drug Product List'' section of the Orange Book.
    Sandoz, Inc. (Sandoz), submitted a citizen petition dated June 21, 
2011 (Docket No. FDA-2011-P-0488), under 21 CFR 10.30, requesting that 
the Agency determine whether TAXOTERE (docetaxel) Injection, 40 mg/mL, 
was withdrawn from sale for reasons of safety or effectiveness. After 
considering the citizen petition and reviewing Agency records and based 
on the information we have at this time, FDA has determined under Sec.  
314.161 that TAXOTERE (docetaxel) Injection, 40 mg/mL was not withdrawn 
for reasons of safety or effectiveness. The petitioner Sandoz has 
identified no data or other information suggesting that TAXOTERE 
(docetaxel) Injection, 40 mg/mL, was withdrawn for reasons of safety or 
effectiveness. We have carefully reviewed our files for records 
concerning the withdrawal of TAXOTERE (docetaxel) Injection, 40 mg/mL, 
from sale. We have also independently evaluated relevant literature and 
data for possible postmarketing adverse events. We have 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 TAXOTERE (docetaxel) 
Injection, 40 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 TAXOTERE (docetaxel) Injection, 40 mg/mL, may be approved by 
the Agency as long as they meet all other legal and regulatory 
requirements for the approval of ANDAs. 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: November 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-30472 Filed 11-25-11; 8:45 am]
BILLING CODE 4160-01-P