Cipla jumps over 3% on FDA nod

about 7 years ago

Cipla, in the opening bell session rose almost 3.5% to Rs.622 but profit booking came in at this level and it is now at Rs.612 levels, up around 2%.

The market is happy with the news that it has received final approval for its Abbreviated New Drug Application (ANDA) for Efavirenz Tablets 600mg from the United States Food and Drug Administration (US FDA).

Cipla’s Efavirenz Tablets 600mg is AB-rated generic therapeutic equivalent version of Bristol-Myers Squibb Pharma Company’s, Sustiva. It is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 infection in adults and in pediatric patients at least 3 months old and weighing at least 3.5 kg.

According to IQVIA (IMS Health), Sustiva and its generic equivalents had US sales of approximately $105M for the 12-month period ending April 2018.

The company stated that the product is available for shipping immediately.