Cipla Limited (‘Cipla’) today announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Atazanavir Caps 100mg, 150mg, 200mg, 300mg from the United States Food and Drug Administration (US FDA).
Cipla’s Atazanavir Caps 100mg, 150mg, 200mg, 300mg is AB-rated generic therapeutic equivalent version of Bristol-Myers Squibb Pharma Company’s, Reyataz. It is a protease inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in patients with minimum age of 6 years and older weighing at least 15 kg.
According to IQVIA (IMS Health), Reyataz and its generic equivalents had US sales of approximately $324M for the 12-month period ending April 2018.
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