Aurobindo Gets Tentative Approval For Lopinavir/Ritonavir Tablets
India’s Aurobindo Pharma has notified that it has secured tentative approval from US Food and Drug Administration (USFDA) for marketing generic lopinavir/ritonavir tablets.
It should be noted that the drug are generic equivalent of Abbott Laboratories' (ABT) Kaletra tablets and falls under anti-retrovial (ARV) segment.
The drugs are prescribed for the treatment of HIV-1 infection in adults and children above the age of two years. The tablets are used together with other anti-retroviral agents.
This is the first generic product tentatively approved under Presidents emergency plans for AIDS relief (PEPFAR) for Abbott`s Kaletra.
With this latest addition, Aurobindo now has a total of 93 abbreviated new drug application (ANDA) approvals from USFDA, out of which 66 are final and 27 are tentative.
At 12:30 p.m., the shares of Aurobindo Pharma gained Rs 2.15, or 1.36%, to trade at Rs 160.35 on the Bombay Stock Exchange (BSE). The total volume of shares traded was 7,198. Current EPS & P/E ratio stood at 20.99 and 7.64 respectively. The share price has seen a 52-week high of Rs 360 and a low of Rs 101.60 on BSE.