FDA Acceptes New Drug Application For POZEN’s Vimovo

POZEN has reported that the FDA has accepted the New Drug Application (NDA) for Vimovo (PN 400).

Vimovo is a fixed-dose combination of enteric-coated naproxen, pain-relieving non-steroidal anti-inflammatory drug (NSAID), and immediate release esomeprazole.

Vimovo is under investigation for the treatment of the signs and symptoms of osteoarthritis (OA), rheumatoid arthritis (RA) and ankylosing spondylitis (AS) in patients who are at risk of developing NSAID-associated gastric ulcers.

In accordance with the terms of the agreement between POZEN and AstraZeneca, the FDA’s notification of acceptance of the NDA filing for Vimovo prompts a $10m milestone payment from AstraZeneca to POZEN.

POZEN, a pharmaceutical company, which develops therapeutic for diseases with unmet medical needs. POZEN’s efforts are focused primarily on the development of pharmaceutical products for the treatment of acute and chronic pain and other pain-related conditions.