FDA Notifications
New hepatitis list serve is launched by the FDA
The Food and Drug Administration is launching a new hepatitis list serve. This new e-mail list will provide updates on safety and regulatory issues related to hepatitis B and C products as they become available (rather than on a regularly scheduled basis).
The e-mail list is intended to give patients, industry, academia, government agencies, and other interested parties, one source for FDA hepatitis B and C related information on a variety of topics, including:
- product approvals,
- significant labeling changes,
- safety warnings,
- notices of upcoming public meetings,
- proposed regulatory guidance, and
- opportunity to comment.
You can subscribe to the new hepatitis e-mail list by visiting this link: http://service.govdelivery.com/service.
FC2 female condom receives FDA approval
The FDA granted regulatory approval to the FC2 female condom on March 11, 2009.
The new female condom is a lower-cost, second generation product manufactured by the Female Health Company. It's the only method available to prevent HIV infection and unintended pregnancy that is designed for women's initiation.
The new female condom will sell for 30% less than its predecessor, the FC1.
The FC2 has the same design, appearance, safety, effectiveness, and use as the FC1, but it is made of a different material. It is made of nitrile, a synthetic rubber.
Female condoms account for 0.2% of the world's total condom supply, and they make up 1.6% of U.S. international condom shipments.
Generic lopinavir/ritonavir approved by FDA
On March 10, 2009, the Food and Drug Administration (FDA) granted tentative approval for a generic formulation of lopinavir/ ritonavir Tablets, 200 mg/50 mg, manufactured by Matrix Laboratories, Ltd., of Hyderabad, India, for use in combination with other antiretroviral agents for the treatment of HIV-1 infection.
This is a generic formulation of Kaletra Tablets, 200 mg/50 mg made by Abbott Laboratories.
"Tentative approval" means that FDA has concluded that a drug product meets all required quality, safety and efficacy standards, but is not eligible for marketing in the U.S. because of existing patents. Tentative approval, however, does make the product eligible for consideration for purchase outside the United States under the President's Emergency Plan for AIDS Relief (PEPFAR).
Effective patent dates can be found in the agency's publication titled Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the "Orange Book."
This application was reviewed under expedited review provisions developed by FDA for the PEPFAR program. As with all generic applications, FDA conducts an on-site inspection of each manufacturing facility, and of the facilities performing the bioequivalence studies, to evaluate the ability of the manufacturer to produce a quality product and to assess the quality of the bioequivalence data supporting the application prior to granting approval or tentative approval to these applications.
A list of all Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan is available on the FDA website at www.fda.gov.
FDA grants approval to generic lamivudine tablets
On March 16, 2009, the Food and Drug Administration granted tentative approval to a generic formulation of lamivudine tablets, 150 mg, for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. The drug is manufactured by Alkem Labs Ltd., of Mumbai, India.
Tentative FDA approval: Abacavir & lamivudine
On March 30, 2009, the FDA granted tentative approval for abacavir sulfate and lamivudine tablets, 600 mg/300 mg, manufactured by Matrix Laboratories Limited of Hyberdad, India, for use in combination with other antiretrovirals in the treatment of HIV infection. The application was reviewed under expedited review provisions for the President's Emergency Plan for AIDS Relief (PEPFAR).
The Food and Drug Administration is launching a new hepatitis list serve. This new e-mail list will provide updates on safety and regulatory issues related to hepatitis B and C products as they become available (rather than on a regularly scheduled basis).Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.