[Federal Register: August 7, 2007 (Volume 72, Number 151)]
[Notices]
[Page 44159-44160]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07au07-61]
-----------------------------------------------------------------------
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Tablets) Was Not Withdrawn From Sale for Reasons of Safety or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.
-----------------------------------------------------------------------
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milligram (mg) capsules and naproxen 250-mg tablets) was not withdrawn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 Under FDA regulations, drugs are withdrawn from the list if the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