Strides Arcolab extends rally on USFDA nod for anti-AIDS combination drug

The company said it has had 15 inspections in the past at various facilities, 7 of them had Zero 483s, the rest of them had observations.

Strides Arcolab has rallied 7.5% to Rs 669, extending its previous day’s 6% surge, after the pharmaceutical company said it has received tentative approval from the US health regulator for anti-AIDS combination drug.

The company has received the approval from the United States Food and Drug Administration for its abbreviated new drug application (ANDA) for Tenofovir Disoproxil Fumarate and Emtricitabine tablets in the strengths of 300 mg and 200 mg, Strides Arcolab said in a statement.

The drug is generic equivalent to Gilead Sciences Inc's Truvada tablets and is indicated in combination with other anti-retroviral agents for treatment of HIV-1 infections in adults, it added.

Meanwhile, in another regulatory filing, about clarification of FDA letter said, the company has had 15 inspections in the past at various facilities. While 7 of them had Zero 483s, the rest of them had observations. We have addressed all these observations at all times to the satisfaction of US FDA.

The stock opened at Rs 638 and touched high of Rs 699 on NSE. A combined 154,200 shares changed hands on the counter so far on NSE and BSE.