Notice: Determination that Bretylium Tosylate Injection, 50 Milligrams/
Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or 
Effectiveness

Federal Register: Volume 76, Number 243 (Monday, December 19, 2011)
                  Pages 78669-78670

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) has determined that 
Bretylium Tosylate injection, 50 milligrams (mg)/milliliter (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not withdrawn from sale for reasons of safety or effectiveness.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 Bretylium Tosylate injection, 50 mg/mL, if all 
other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT:  Molly Flannery, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6246, Silver Spring, MD 20993-0002, (301) 
796-3543.

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drug was withdrawn from sale for reasons of safety or effectiveness (21 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.
    Bretylium Tosylate injection, 50 mg/mL, is the subject of NDA 19-
030, held by Hospira, Inc., and initially approved on April 16, 1986. 
Bretylium Tosylate injection, 50 mg/mL, is indicated in the prophylaxis 
and therapy of ventricular fibrillation and in the treatment of life-
threatening ventricular arrhythmias, such as ventricular tachycardia, 
that have failed to respond to adequate doses of a first-line 
antiarrhythmic agent, such as lidocaine.
    In a letter dated June 17, 2010, Hospira, Inc. requested withdrawal 
of NDA 19-030 for Bretylium Tosylate injection, 50 mg/mL. In the 
Federal Register of June 8, 2011 (76 FR 33310), FDA announced that it 
was withdrawing approval of NDA 019030, effective July 8, 2011.
    Academic Pharmaceuticals, Inc. submitted a citizen petition dated 
July 27, 2011 (Docket No. FDA-2011-P-0578), under 21 CFR 10.30, 
requesting that the Agency determine whether Bretylium Tosylate 
injection, 50 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 Bretylium Tosylate injection, 50 mg/mL, was 
not withdrawn for reasons of safety or effectiveness. We have carefully 
reviewed the information provided by the petitioner and our files for 
records concerning the withdrawal of Bretylium

[[Page 78670]]

Tosylate injection, 50 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 Bretylium Tosylate 
injection, 50 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 Bretylium Tosylate injection, 50 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: December 12, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-32367 Filed 12-16-11; 8:45 am]
BILLING CODE 4160-01-P