Lupin Limited granted tentative FDA approval for insomnia drug

Lupin Limited has received tentative approval from the Food and Drug Administration (FDA) for the sale of a generic insomnia treatment.

The company’s pharmaceuticals division received backing for its abbreviated new drug application for eszopiclone, an AB-rated generic version of Sepracor’s tablet-based Lunesta product.

Having received the approval, the company will now be able to introduce its drug once Sepracots’ Lunesta patent expires in 2012.

Vinita Gupta, president and chief executive officer of Lupin Pharmaceuticals, expressed satisfaction at the FDA’s decision and said the company is looking forward to being able to launch its generic alternative.

According to IMS Health data, sales of the branded version of the drug generated $761 million (507.7 million pounds) in the 12-month period ending in December 2009.

Last month, the company received final approval from the FDA for its new Amlodipine/Benazepril capsules, which are a generic version of the Lotrel hypertension treatment produced by Novartis.