Leading pharmaceutical company Lupin Ltd has received tentative approval from the US Food and Drug Administration (FDA) for its generic drug Sertraline Hydrochloride for treatment of major depressive disorder.
Mumbai based Lupin's Sertraline Hydrochloride tablets will be the AB-rated generic equivalent of Pfizer's Zoloft tablets of 25mg, 50mg and 100mg dosage.
"The company intends to launch the generic (drug) on final approval, which is expected upon expiration of the marketing exclusivity (of Pfizer's Zoloft) for the product in February 2007," a company statement said here Tuesday.
This is Lupin's 18th Abbreviated New Drug Application (ANDA) to have received US FDA approval till date.
The company is a leading global player in anti-tuberculosis, cephalosporins (anti-infectives) and cardiovascular drugs (prils and statins) and has a notable presence in the areas of diabetology, non-steroidal anti-inflammatory drugs (NSAIDS) and asthma.