[Federal Register Volume 75, Number 129 (Wednesday, July 7, 2010)]
[Notices]
[Pages 39025-39026]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-16438]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES>
Food and Drug Administration
[Docket Nos. FDA-2010-P-0027, FDA-2010-P-0059, and FDA-2010-P-0051]
Determination That ACTONEL (Risendronate Sodium) Tablets, 75
Milligrams, and ACTONEL WITH CALCIUM (Risendronate Sodium and Calcium
Carbonate (Copackaged)) Tablets, 35 Milligrams/500 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Withdrawn From Sale for Reasons of Safety or Effectiveness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) is announcing the
determination that ACTONEL (risendronate sodium) Tablets, 75 milligrams
(mg), and ACTONEL WITH CALCIUM (risendronate sodium and calcium
carbonate (copackaged)) Tablets, 35 mg/500 mg, were not withdrawn from
sale for reasons of safety or effectiveness. This determination will
allow FDA to approve abbreviated new drug applications (ANDAs) for
these products, if all other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Jane Baluss, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6362, Silver Spring, MD 20993-0002, 301-
796-3469.
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
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). 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
[[Page 39026]]
ANDA that does not refer to a listed drug.
Lachman Consultant Services submitted a petition dated January 12,
2010 (FDA-2010-P-0027), requesting a determination that ACTONEL
(risendronate sodium) Tablets, 75 milligrams (mg), was not withdrawn
from sale for reasons of safety or effectiveness. ACTONEL (risendronate
sodium) Tablets, 75 mg, is the subject of NDA 20-835, held by Warner
Chilcott and initially approved on April 16, 2004. ACTONEL
(risendronate sodium) Tablets, 75 mg, is indicated for the treatment of
postmenopausal osteoporosis in men, and Paget's disease in men and
women.
In a separate citizen petition dated January 20, 2010 (FDA-2010-P-
0051), Lachman Consultant Services requested a determination that
ACTONEL WITH CALCIUM (risendronate sodium and calcium carbonate
(copackaged)) Tablets, 35/500 mg, was not withdrawn from sale for
reasons of safety or effectiveness. In another separate petition dated
January 21, 2010, EAS Consulting Group, LLC, requested the same
determination on behalf of Aurobindo Pharmaceuticals. ACTONEL WITH
CALCIUM (risendronate sodium and calcium carbonate (copackaged))
Tablets, 35/500 mg, is the subject of NDA 21-823, held by Procter &
Gamble and initially approved on August 12, 2005. ACTONEL WITH CALCIUM
(risendronate sodium and calcium carbonate (copackaged)) Tablets, 35/
500 mg, is indicated for the treatment of postmenopausal osteoporosis.
FDA has reviewed its records and, under Sec. 314.161, has
determined that neither ACTONEL (risendronate sodium) Tablets, 75 mg,
nor ACTONEL WITH CALCIUM (risendronate sodium and calcium carbonate
(copackaged)) Tablets, 35/500 mg, was withdrawn from sale for reasons
of safety or effectiveness. None of the petitions identified any data
or other information suggesting that either of the products named in
the petitions was withdrawn for reasons of safety or effectiveness. FDA
has independently evaluated relevant literature and data for possible
postmarketing adverse events and has found no information that would
indicate that either product was withdrawn from sale for reasons of
safety or effectiveness. Accordingly, the agency will continue to list
ACTONEL (risendronate sodium) Tablets, 75 mg, and ACTONEL WITH CALCIUM
(risendronate sodium and calcium carbonate (copackaged)) Tablets, 35/
500 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.
ANDAs that refer to ACTONEL (risendronate sodium) Tablets, 75 mg,
or ACTONEL WITH CALCIUM (risendronate sodium and calcium carbonate
(copackaged)) Tablets, 35/500 mg, may be approved by the agency if all
other legal and regulatory requirements for the approval of ANDAs are
met. If FDA determines that labeling for either or both of these drug
products should be revised to meet current standards, the agency will
advise ANDA applicants to submit such labeling.
Dated: June 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-16438 Filed 7-6-10; 8:45 am]
BILLING CODE 4160-01-S