Cipla gains 3% post USFDA approval for its generic HIV drug

Shares of Cipla were up 3% at Rs 622 per share on the BSE in early morning trade after the company said that it has received approval from the US Food and Drug Administration (USFDA) to market Efavirenz tablets, used to treat HIV-1 infections in adults.

The stock of pharmaceutical company is 6.6% away from its 52-week high of Rs 663 touched on November 7, 2017 on the BSE.

“The company has received final approval for its Abbreviated New Drug Application (ANDA) for Efavirenz tablets 600mg from the United States Food and Drug Administration (USFDA),” Cipla said in a press release on Tuesday after market hours.

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, it added.

According to IQVIA (IMS Health), Sustiva and its generic equivalents had US sales of approximately $105 million for the 12-month period ending April 2018. The product is available for shipping immediately, the company said.

At 09:28 am; Cipla was trading 2.6% higher at Rs 618 on the BSE, as compared to 0.3% rise in the S&P BSE Sensex. A combined 2.08 million shares changed hands on the counter on the NSE and BSE so far.