[Federal Register Volume 72, Number 151 (Tuesday, August 7, 2007)]
[Notices]
[Pages 44159-44160]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-15233]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006P-0462]


Determination That PREVACID NAPRAPAC (Copackaged Lansoprazole 
Delayed-Release 15-Milligram Capsules and Naproxen 250-Milligram 
Tablets) Was Not Withdrawn From Sale for Reasons of Safety or 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 
PREVACID NAPRAPAC 250 (copackaged lansoprazole delayed-release 15-
milligram (mg) capsules and naproxen 250-mg tablets) was not withdrawn 
from sale for reasons of safety or effectiveness. This determination 
will allow FDA to approve abbreviated new drug applications (ANDAs) for 
copackaged lansoprazole delayed-release 15-mg capsules and naproxen 
250-mg tablets.

FOR FURTHER INFORMATION CONTACT: Marguerita B. Sims, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5041.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) 
(the 1984 amendments), which authorized the approval of duplicate 
versions of drug products approved under an ANDA procedure. ANDA 
sponsors 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. Sponsors of ANDAs do 
not have to repeat the extensive clinical testing otherwise necessary 
to gain approval of an 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 Under FDA regulations, drugs are withdrawn from the list if the 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).
    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.
    PREVACID NAPRAPAC 250 is the subject of NDA 21-507 held by Tap 
Pharmaceuticals, Inc. (TAP). PREVACID NAPRAPAC 250 is a copackaged drug 
product that contains Prevacid (lansoperazole) 15-mg delayed-release 
capsules (a proton-pump inhibitor) and Naprosyn (naproxen) 250-mg 
tablets (a nonsteroidal anti-inflammatory drug product (NSAID) with 
analgesic and antipyretic properties). PREVACID NAPRAPAC 250 is 
indicated for reducing the risk of NSAID-associated gastric ulcers in 
patients with a history of documented gastric ulcer(s) who require the 
use of an NSAID for treatment of the signs and symptoms of rheumatoid 
arthritis, osteoarthritis, and/or ankylosing spondylitis. TAP's 
PREVACID NAPRAPAC 250 was discontinued in October 2006.
    In a citizen petition received on November 13, 2006 (Docket No. 
2006P-0462/CP1), submitted under 21 CFR 10.30 and in accordance with 
Sec.  314.161, Robert W. Pollock of Lachman

[[Page 44160]]

Consultant Services, Inc., requested that FDA determine whether 
PREVACID NAPRAPAC 250 was withdrawn from sale for reasons of safety or 
effectiveness.
    For the reasons outlined previously, FDA has determined that TAP's 
PREVACID NAPRAPAC 250 was not withdrawn from sale for reasons of safety 
or effectiveness. In support of this finding, the agency notes that a 
higher strength of PREVACID NAPRAPAC 250 [PREVACID NAPRAPAC 500 (15 mg/
500 mg)] is currently being marketed. In addition, the petitioner 
identified no data or information suggesting that PREVACID NAPRAPAC 250 
was withdrawn from sale for reasons of safety or effectiveness. FDA's 
independent evaluation of relevant literature and data has not 
uncovered anything that would indicate that this product was withdrawn 
for reasons of safety or effectiveness.
    After considering the citizen petition and reviewing agency records 
concerning the withdrawal, FDA found no indication that the decision 
not to commercially market PREVACID NAPRAPAC 250 was a result of any 
safety or effectiveness concerns regarding the product. Accordingly, 
the agency will continue to list PREVACID NAPRAPAC 250 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 PREVACID NAPRAPAC 250 
may be approved by the agency as long as they meet all relevant legal 
and regulatory requirements for the approval of ANDAs. If FDA 
determines that labeling for these drug products should be revised to 
meet current standards, the agency will advise ANDA applicants to 
submit such labeling.

    Dated: July 30, 2007.
Randall W. Lutter
Deputy Commissioner for Policy.
[FR Doc. E7-15233 Filed 8-6-07; 8:45 am]
BILLING CODE 4160-01-S