Mylan Matrix’ lansoprazole (Prevacid) generic gets US FDA approval

Matrix Laboratories, a subsidiary of Mylan Inc, has received final approval for lansoprazole delayed-release capsules from the US Food and Drug Administration.

Lansoprazole delayed-release capsules are the generic version of Tap Pharmaceuticals’ proton pump inhibitor Prevacid DR capsules.

US Food and Drug Administration has approved Matrix’Abbreviated New Drug Application (ANDA) for lansoprazole delayed-release capsules in 15 mg and 30 mg strengths, the company said in a press release.

Matrix Laboratories will commence marketing of lansoprazole immediately and will be sold under the Mylan Pharmaceuticals brand.

Lansoprazole delayed-release capsules product had US sales of approximately US$ 3 billion for the 12 months ending June 30, according to IMS Health.

Currently, Mylan has 125 ANDAs pending FDA approval representing US$ 84.1 billion in annual brand sales, according to IMS Health.

Thirty-seven of Mylan’s pending ANDAs are potential first-to-file opportunities, representing US$ 19.2 billion in annual brand sales, for the 12 months ending June 30, according to IMS Health.

Matrix Lab received tentative approval under the President’s Emergency Plan for AIDS Relief (PEPFAR) in September for a fixed-dose combination (FDC) of efavirenz, emtricitabine, tenofovir disoproxil fumarate tablets, 600 mg/200 mg/300 mg.

Matrix Lab’s efavirenz, emtricitabine and tenofovir combination pill is the generic version of Gilead Sciences’ Atripla tablets.

Atripla is indicated for the treatment of HIV-1 infection in adults.

Single combination pills containing several drugs into a once daily dose can dramatically reduce pill burden, and improve patient compliance with complex AIDS treatment regimens.

In 2007, Matrix signed an agreement with the Clinton HIV/AIDS Initiative (CHAI) that significantly lowers the price of AIDS treatment for second-line anti-retroviral drugs (ARVs), as well as a new, once-a-day pill that is currently cost prohibitive in the developing world.

This deal made Matrix one of the key suppliers of affordable second-line Antiretroviral (ARV) drugs into 66 low- and middle-income countries in Africa, Asia, Latin America and the Caribbean. Second-line treatment is required in patients who develop resistance to first-line treatment and typically costs 10 times the price of first-line therapy. Nearly half a million patients will require these drugs by 2010.

Approximately 30% of HIV/AIDS patients in developing countries depend on at least one Matrix ARV product.

Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to more than 140 countries and territories.

Mylan Matrix, which runs a specialty business focused on respiratory and allergy therapies, is the world’s third largest active pharmaceutical ingredient manufacturer.

Matrix Laboratories has API manufacturing facilities at four locations in and around Hyderabad and Visakhapatnam, India. Matrix Lab’s solid oral dosage forms facility is located near Nashik, about 150 km from Mumbai. All of Matrix Lab’s facilities are USFDA approved. The facilities also have ISO 9000, ISO 14000 Certifications.