[Federal Register Volume 75, Number 248 (Tuesday, December 28, 2010)]
[Notices]
[Pages 81617-81618]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-32507]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-P-0326]
Determination That TRANDATE (Labetalol Hydrochloride) Tablets,
300 Milligrams and 400 Milligrams, Were Not Withdrawn From Sale for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
TRANDATE (labetalol hydrochloride) tablets, 300 milligrams (mg) and 400
mg, were not withdrawn from sale for reasons of safety or
effectiveness. This determination means that FDA will not begin
procedures to withdraw approval of abbreviated new drug applications
(ANDAs) that refer to these drug products, and it will allow FDA to
continue to approve ANDAs that refer to the products as long as the
ANDAs meet relevant legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Deborah Livornese, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6306, Silver Spring, MD 20993-0002, 301-
796-0719.
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 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
(Sec. 314.162 (21 CFR 314.162)). Under Sec. 314.161(a)(1) (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. Under Sec.
314.161(a)(2), FDA must determine whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness whenever a listed drug
is voluntarily withdrawn from sale and ANDAs that refer to the listed
drug have been approved. Section 314.161(d) provides that if FDA
determines that a listed drug was withdrawn from sale for reasons of
safety or effectiveness, the Agency will initiate proceedings that
could result in the withdrawal of approval of the ANDAs that refer to
the listed drug.
TRANDATE (labetalol hydrochloride) tablets, 300 mg and 400 mg, are
the subject of NDA 18-716, held by Prometheus Laboratories, Inc., and
initially approved on August 1, 1984. TRANDATE is indicated for the
management of hypertension. TRANDATE (labetalol hydrochloride) tablets,
300 mg and 400 mg, are currently listed in the ``Discontinued Drug
Product List'' section of the Orange Book. TRANDATE (labetalol
hydrochloride) tablets, 400 mg, have never been marketed. 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 drug product is
equivalent to withdrawing the drug from sale.
JRRapoza Associates, Inc., submitted a citizen petition dated June
16, 2010 (Docket No. FDA-2010-P-0326), under 21 CFR 10.30, requesting
that the Agency determine whether TRANDATE (labetalol hydrochloride)
tablets, 300 mg, were withdrawn from sale for reasons of safety or
effectiveness. Although the citizen petition did not address the 400 mg
strength, on our own initiative, we have also determined whether that
strength was withdrawn for safety or effectiveness reasons.
After considering the citizen petition and reviewing Agency
records, FDA has determined under Sec. 314.161 that
[[Page 81618]]
TRANDATE (labetalol hydrochloride) tablets, 300 mg and 400 mg, were not
withdrawn for reasons of safety or effectiveness. The petitioner has
identified no data or other information suggesting that TRANDATE
(labetalol hydrochloride) tablets, 300 mg and 400 mg, were withdrawn
for reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of TRANDATE (labetalol
hydrochloride) tablets, 300 mg and 400 mg, from sale. We have also
independently evaluated relevant literature and data for possible
postmarketing adverse events and 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 TRANDATE (labetalol
hydrochloride) tablets, 300 mg and 400 mg, 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. FDA will not begin procedures to withdraw approval of
approved ANDAs that refer to the TRANDATE products listed in this
document. Additional ANDAs that refer to these products may also 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 21, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-32507 Filed 12-27-10; 8:45 am]
BILLING CODE 4160-01-P