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Mylan subsidiary gets FDA tentative approval for Atazanavir Sulfate capsules

Matrix Laboratories, a subsidiary of Mylan, has got tentative US Food and Drug Administration (FDA) approval under the President's Emergency Plan for AIDS Relief (PEPFAR) for its Atazanavir Sulfate capsules, 150mg and 300mg abbreviated new drug application (ANDA).

A generic version of Bristol Myers Squibb’s Reyataz capsules, Atazanavir Sulfate capsules are used in conjunction with the other medications to control HIV infection and is included in the ARV class of drugs known as HIV protease inhibitors.

Mylan president Heather Bresch said that Atazanavir has a distinct resistance profile compared with other protease inhibitors and is an important addition to the product portfolio being made available to patients in developing countries.

“With every new generic Antiretroviral (ARV), patient care in these affected areas improves and becomes more affordable,” Bresch said.