“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