The Food and Drug Administration (FDA) has announced the tentative approval of generic abacavir (a-BAK-a-veer) sulfate tablets manufactured by Aurobindo Pharma. The approval has been obtained for 30 mg tablets, which have an estimated market of $140 million in the US, an official at Aurobindo told Pharmabiz.
Abacavir sulfate tablets are the first generic version of the already approved Ziagen Tablets, an anti-HIV medication manufactured by GlaxoSmithKline. This product will now be available for consideration for purchase under the President's Emergency Plan for AIDS Relief.
The development is a result of continued efforts and investments made by the company in building a strong pipeline and the company has been a forerunner in the number of filings, sources said.
The President's Emergency Plan for AIDS Relief, which president Bush first announced in his 2003 State of the Union Address, is currently providing $15 billion to fight the HIV/AIDS pandemic over five years, with a special focus on 15 of the hardest hit countries.
The President's plan is designed to prevent seven million new HIV infections, treat at least two million HIV-infected people, and care for ten million HIV-affected individuals, AIDS orphans and vulnerable children.
Abacavir is one of the non-nucleoside reverse transcriptase inhibitors (NRTIs), a class of drugs that helps keep the AIDS virus from reproducing. It is used in combination with other anti-retroviral agents for the treatment of HIV-1 infection.
The agency's tentative approval of this product means that Aurobindo's product meets all of FDA's manufacturing quality and clinical safety and efficacy standards. Although existing patents and/or exclusivity prevent its marketing in the United States, the product can be marketed abroad and used under the PEPFAR plan, sources informed.