FDA accepts Meda's filing for new form of azelastine

Sweden's Meda says that its New Drug Application for a newly-formulated higher strength azelastine nasal spray has now been accepted by the US Food and Drug Administration as complete for substantive review after initial evaluation.

"This product has the potential to become the first once-a-day nasal antihistamine in the USA. Beside better tolerance with the new formulation it could also mean better compliance for patients. The product would contribute significantly to Meda's allergy franchise," said Anders Lonner, the firm's chief executive.

Meda has completed six Phase III trials and a long-term safety study, involving more than 1,600 patients in total. In these clinical evaluations, the product demonstrated improvement in nasal symptom relief scores in patients with seasonal and perennial allergic rhinitis, and it was well tolerated, the company noted.