[Federal Register Volume 76, Number 243 (Monday, December 19, 2011)]
[Notices]
[Pages 78669-78670]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-32367]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-P-0578]
Determination that Bretylium Tosylate Injection, 50 Milligrams/
Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or
Effectiveness
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not withdrawn from sale for reasons of safety or effectiveness.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