Morepen gets USFDA nod to market generic anti-allergy drug

Drug firm Morepen Laboratories on Friday said it has received approval from the US health regulator to market its anti-allergy drug Fexofinadine Hydrochloride in the American market. The company sells the product in India under the brand name Allegra.

Morepen's product is the generic version of Sanofi Aventis' anti- allergy drug.

Fexofinadine is the most widely used, second generation antihistamine drug for the treatment of allergy symptoms and hay fever.

In a statement, the company said it has tied up for regular supplies of Fexofinadine to 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, it added.

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

It also cements the company's long-standing relations with its prime customers who have worked with the firm for two decades, he added.

The latest approval takes the tally of approvals from the company's manufacturing plant in Baddi (Himachal Pradesh) to five.

Morepen has strong portfolio of APIs (Active Pharmaceutical Ingredient) with market size of over USD 42 billion, which is going off-patent over next 7-8 years and is building additional capacities in a multiphase USFDA expansion as demand for niche molecules and global customers remain stronger than ever, the company stated.

The drug firm is looking to address USD 42 billion market in the future as compared to USD 2 billion currently, it added.

Fexofinadine is marketed primarily in two dosage forms - 120 mg and 180 mg - and is available to buy over the counter in many countries including the US, 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.