Morepen Laboratories secures FDA approval for Fexofinadine (Allegra)

Morepen Laboratories Limited has secured approval from the US Food and Drug Administration (FDA) for its anti-allergy drug Fexofinadine Hydrochloride, which it expects to begin approval in the fourth quarter of 2022.

The anti-allergy drug, which is sold in India under the brand names such as Allegra and others, was developed by France-based Sanofi Aventis.

Fexofinadine is a second generation antihistamine drug used for treating allergy symptoms and hay fever.

Morepen Laboratories said that it has partnered for regular supplies of Fexofinadine to one of its major customers in the US, with which it has long standing relations lasting more than 20 years. The Indian pharma company added that it has already provided validation quantities and the regular commercial supplies would begin following approval of validation batches.

Fexofinadine has a market size of nearly 700MT and is anticipated to give an immediate push to its export business, said Morepen Laboratories.

Sushil Suri — Chairman and Managing Director of Morepen Laboratories said: “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.

“It also cements our long-standing relations with our prime customers who have worked with us for two decades and shows their confidence in company’s product quality and delivery.”