
[Federal Register Volume 75, Number 248 (Tuesday, December 28, 2010)]
[Notices]
[Pages 81617-81618]
From the Federal Register Online via the Government Printing 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300 Milligrams and 400 Milligrams, Were Not Withdrawn From Sale for 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mg, were not withdrawn from sale for reasons of safety or 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


