Aurobindo gets first approval from Swissmedic for BPH drug

Aurobindo Pharma Ltd, a Hyderabad-based manufacturer of generic pharmaceuticals and active pharmaceutical ingredients (APIs), has received its first approval from Swissmedic for the license of Finasteride APL tablets in 5mg strength.

Swissmedic, an agency for therapeutic products, is a surveillance authority for medicines and medical devices registered in Switzerland's capital city Bern. Established in 2002, Swissmedic is affiliated to the federal department of home affairs.

Finasteride APL tablets are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate, the company said in a press release on Wednesday.

This is the second such approval for Aurobindo Pharma from a foreign public health agency in the last four months, with the first being an approval from Health Canada, a department of the Canadian government with responsibility for national public health.

Health Canada approved Aurobindo's abbreviated new drug submission Terbinafine tablets in 125mg and 250mg strengths in December 2008. Terbinafine is the generic equivalent of Novartis Pharmaceutical Canada Inc's Lamisil tablets, indicated for the treatment of fungal infections of the skin and nails.

The scrip of Aurobindo is currently trading at Rs 193.40 on the BSE on the BSE on Wednesday, as against the previous close of Rs 190.