Lupin’s sleep disorder drug gets USFDA nod

Lupin Pharmaceuticals, drug maker Lupin Ltd's US-based pharma arm has received a tentative approval from the US drugs regulator for Eszopiclone tablets used in the treatment of sleep disorder.

In a filing to the Bombay Stock Exchange, Lupin said a tentative approval for the company's abbreviated new drug application (ANDA) for Eszopiclone tablets had been received from the US Food and Drug Administration (USFDA).

Lupin Pharmaceuticals president and CEO Vinita Gupta said the company was looking forward to offer Eszopiclone tablets to the US market as an affordable generic alternative post patent expiry and was pleased to receive the tentative approval.

The drug will be available in 1mg, 2mg and 3mg strength according to the filing.

The product will be offered in the market through Lupin Pharmaceuticals' extensive network of national wholesalers and pharmacy chains post patent expiry in 2012, according to the company.

The branded product logged approximately $761 million in annual sales for the twelve months ended December 2009, according to IMS Health sales data.

Last week, Lupin received final approval from US Food & Drug Administration (US FDA) for Imipramine Hydrochloride, the generic version of Mallinckrodt's Tofranil tablets.

The drug, available in varying strengths is used in the treatment of depression.

Lupin's net profit vaulted 152.7 per cent to Rs222.70 crore on a 37.8 per cent surge in net sales to Rs1004.50 crore in Q3 December 2009 over Q3 December 2008.

Lupin is engaged in the manufacture of active pharmaceutical ingredients and formulations.