HIV/AIDS Update -Tentative approval of atazanavir sulfate capsules, 100 mg, 150 mg, 200 mg, and 300 mg

[Date Prev][Date Next][Thread Prev][Thread Next][Date Index][Thread Index]

 



Title: HIV/AIDS Update -Tentative approval of atazanavir sulfate capsules, 100 mg, 150 mg, 200 mg, and 300 mg

FDA HIV/AIDS List Serve Image

You are receiving this message as a subscriber to the FDA HIV/AIDS electronic list serve. The purpose of the list serve is to relay important information about HIV/AIDS-related products and issues, including product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings and alerts to proposed regulatory guidances for comment.

Please do not reply to this message.

On January 31,2014, FDA granted tentative approval for a generic formulation of atazanavir sulfate capsules, 100 mg, 150 mg, 200 mg, and 300 mg, indicated for use in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV)-1 infection.

The product is made by Aurobindo Pharma Ltd. of Hyderabad, India.  It is a generic version of Reyataz capsules, made by Bristol -Myers-Squibb Company.

The application was reviewed under the expedited review provisions of the President’s Emergency Plan for AIDS Relief (PEPFAR ).

"Tentative approval" means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, but is not eligible for marketing in the U.S. because of existing patent protections. Tentative approval does, however, make the product eligible for purchase outside the United States under the PEPFAR program.

A complete list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan  is available on the FDA web site.

Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration

Kimberly Struble
Division of Antiviral Products
Food and Drug Administration

Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration

 

 


This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 Powered by GovDelivery

[Index of Archives]     [CDC News]     [NIH News]     [USDA News]     [Steve's Art]     [Camping in Yosemite]     [PhotoForum]     [SB Lupus]     [STB]

  Powered by Linux