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India’s Strides gets tentative US FDA approval for HIV pill abacavir (Ziagen) generic under PEPFAR

Thursday, May 20, 2010, 20:05 This news item was posted in Industry category and has 0 Comments so far.

Indian generic firm Strides Arcolab has received tentative US FDA approval for its generic drug abacavir sulfate in tablet form, the expedited review provisions of the President’s Emergency Plant for AIDS Relief (PEPFAR).

Abacavir tablets are used to treat HIV infected patients.

Strides got approval for abacavir pills in 300mg strength.

Abacavir sulfate, also known as Ziagen or ABC, is a nucleoside reverse transcriptase inhibitor (NRTI). NRTIs block reverse transcriptase, a protein that HIV needs to make more copies of itself.

Abacavir sulfate was approved by the FDA on December 17, 1998, for use with other antiretroviral drugs in the treatment of HIV infection in adults and children 3 months of age or older.

Abacavir and lamivudine are available in a single tablet called Epzicom. Abacavir, lamivudine, and zidovudine are available in a single tablet called Trizivir.

The recommended dosage of abacavir sulfate for adults is 300 mg twice a day. For children and adolescents age 3 months to 16 years, the recommended dosage is 8 mg/kg twice a day (up to a maximum of 300 mg twice a day).

The President’s Emergency Plan For AIDS Relief (PEPFAR) was aimed to fight the global HIV/AIDS pandemic over five years (2003–2008) from United States President George W. Bush with a commitment of $15 billion. The goals of PEPFAR include support for treatment for 2 million HIV infected people, support for prevention of 7 million new infections, and support for care for 10 million people infected or affected by HIV/AIDS. PEPFAR has been called the largest health initiative ever initiated by one country to address a disease.

In May 2009, India’s generic major Cipla received tentative approval for HIV drug tenofovir disoproxil fumarate tablets, 300 mg, from United States Food and Drug Administration (USFDA) under PEPFAR.

Tenofovir disoproxil fumarate tablets are indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.

Recently, world’s top drug maker Pfizer has expanded its generics sourcing alliance with India’s Strides Arcolab to include more injectable products and more markets.

The new collaboration between Pfizer and Strides Arcolab now extends to a total of 45 products addressing countries around the globe.

In January, Pfizer entered into a collaboration with India’s Strides Arcolab on the supply of 40 generic products.

Under the new agreement, Strides will license and supply up to 38 generic oncology products to Pfizer for markets in the European Union, Canada, Australia, New Zealand, Japan, and Korea.

The second agreement covers niche sterile injectables for the US market.

Strides Arcolab is a global pharmaceutical company headquartered in Bangalore, India that develops and manufactures a wide range of IP-led niche pharmaceutical products with an emphasis on sterile injectables.

Strides has 14 manufacturing facilities across 6 countries, including its joint venture with Aspen in India and has a marketing pr

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