Morepen Laboratories has received U.S. FDA approval for its anti-allergy drug Fexofinadine Hydrochloride that is marketed in India under the popular brand name Allegra, among others and is the blockbuster drug of the innovator company Sanofi Aventis, France. Fexofinadine is the most widely used, second-generation antihistamine drug for the treatment of allergy symptoms and hay fever.

The company has tied up for regular supplies of Fexofinadine with one of its top US customers, with which the company has long-standing relations lasting over two decades. The company has already supplied validation quantities and the regular commercial supplies would start after approval of validation batches. Fexofinadine is a very established anti-allergy drug with a market size of around 700MT and expected to give immediate impetus to company's export business.

Sushil Suri, Chairman and Managing Director stated, "Approval of anti-allergy drug Fexofinadine (Allegra) by the U.S. FDA is an important milestone in the company's therapeutic journey since it consolidates Morepen's position in the anti-allergy market with already having FDA approval for three lead products Loratadine, Desloratadine and Montelukast.’’

Fexofinadine is marketed primarily in two dosage forms 120mg and 180mg and is available to buy over the counter in many countries including USA, Australia, New Zealand, and certain countries around Europe. It is also used in combination with other anti-allergy drugs like Montelukast for which Morepen has got the largest manufacturing capacity in the world and is already approved in US market.