According to Meda, the FDA has approved Meda’s Dymista azelastine hydrochloride/fluticasone propionate nasal spray for the treatment of seasonal allergic rhinitis. Meda filed the NDA approximately one year ago, in April 2011.
Meda CEO Anders Lonner said, “Allergic rhinitis is an increasing problem. Many patients have severe symptoms that cause inability to work and live a normal life. Dymista can offer an effective treatment for patients suffering from these symptoms. The approval of Dymista represents an important achievement for Meda’s clinical development groups in the US and Europe. Meda’s franchise in the allergy area is strengthened and gives opportunities for the company to grow and establish collaborations in the field. Dymista will be available in the US during the second half of 2012.”
The company says that the United States Patent and Trademark Office (USPTO) has also issued two patents related to Dymista that extend through 2023 and 2026 respectively.
The FDA has also posted a warning letter to Meda regarding marketing of its Astepro azelastine nasal spray, saying that the company’s telephone script for the product “false or misleading because it presents efficacy claims for Astepro 0.15%, but fails to include any risks associated with its use. In addition, the script overstates the efficacy of Astepro 0.15% and fails to make adequate provision for dissemination of the FDA-approved labeling.”
Read the Meda press release.
Read the FDA warning letter.
