[Federal Register Volume 77, Number 135 (Friday, July 13, 2012)]
[Notices]
[Pages 41411-41412]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-17090]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-P-0271]


Determination That TOPOTECAN INJECTION (Topotecan Hydrochloride) 
1 Milligram (Base)/1 Milliliter, 3 Milligram (Base)/3 Milliliter, 4 
Milligram (Base)/4 Milliliter, Was Not Withdrawn From Sale for Reasons 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 
TOPOTECAN INJECTION (topotecan hydrochloride) 1 milligram (mg) (base)/1 
milliliter (mL), 3 mg (base)/3 mL, 4 mg (base)/4 mL, was not withdrawn 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 
topotecan hydrochloride intravenous solution 1 mg (base)/1 mL, 3 mg 
(base)/3 mL, 4 mg (base)/4 mL, if all other legal and regulatory 
requirements are met.

FOR FURTHER INFORMATION CONTACT: Rachel Turow, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-
796-5094.

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 generally known 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 
(Sec.  314.162 (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.
    TOPOTECAN INJECTION (topotecan hydrochloride) 1 mg (base)/1 mL, 3 
mg (base)/3 mL, 4 mg (base)/4 mL, is the subject of NDA 200199, held by 
Sandoz Inc., and initially approved on February 25, 2011. TOPOTECAN 
INJECTION is indicated for the treatment of small cell lung cancer 
sensitive disease after failure of first-line chemotherapy. In clinical 
studies submitted to support approval, sensitive disease was defined as 
disease responding to chemotherapy but subsequently progressing at 
least 60 days (in the phase 3 study) or at least 90 days (in the phase 
2 studies) after chemotherapy. TOPOTECAN INJECTION in combination with 
cisplatin is indicated for the treatment of stage IV-B, recurrent, or 
persistent carcinoma of the cervix, which is not amenable to curative 
treatment with surgery and/or radiation therapy.
    Sandoz Inc. has never marketed TOPOTECAN INJECTION (topotecan 
hydrochloride) 1 mg (base)/1 mL, 3 mg (base)/3 mL, 4 mg (base)/4 mL. In 
previous instances (see, e.g., 72 FR 9763, March 5, 2007; 61 FR 25497, 
May 21, 1996), the Agency has determined that, for purposes of 
Sec. Sec.  314.161 and 314.162, never marketing an approved

[[Page 41412]]

drug product is equivalent to withdrawing the drug from sale.
    Lachman Consultant Services, Inc., submitted a citizen petition 
dated March 14, 2012 (Docket No. FDA-2012-P-0271), under 21 CFR 10.30, 
requesting that the Agency determine whether TOPOTECAN INJECTION 
(topotecan hydrochloride) 1 mg (base)/1 mL, 3 mg (base)/3 mL, 4 mg 
(base)/4 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 TOPOTECAN INJECTION (topotecan 
hydrochloride) 1 mg (base)/1 mL, 3 mg (base)/3 mL, 4 mg (base)/4 mL, 
was not withdrawn for reasons of safety or effectiveness. The 
petitioner has identified no data or other information suggesting that 
TOPOTECAN INJECTION (topotecan hydrochloride) 1 mg (base)/1 mL, 3 mg 
(base)/3 mL, 4 mg (base)/4 mL, was withdrawn for reasons of safety or 
effectiveness. We have carefully reviewed our files for records 
concerning the withdrawal of TOPOTECAN INJECTION (topotecan 
hydrochloride) 1 mg (base)/1 mL, 3 mg (base)/3 mL, 4 mg (base)/4 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 TOPOTECAN INJECTION 
(topotecan hydrochloride) 1 mg (base)/1 mL, 3 mg (base)/3 mL, 4 mg 
(base)/4 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 
TOPOTECAN INJECTION (topotecan hydrochloride) 1 mg (base)/1 mL, 3 mg 
(base)/3 mL, 4 mg (base)/4 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: July 10, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-17090 Filed 7-12-12; 8:45 am]
BILLING CODE 4160-01-P