Latest From Ony Inc.
Last patent covering Pfizer’s pain drug is a reissue of an earlier patent on which 180-day exclusivity has already been triggered; FDA has previously declined to award exclusivity to such patents.
In separate “notice of violation” letters issued Oct. 31 but posted several days apart, FDA rejected superiority claims on the part of Cornerstone Therapeutics and Ony for their respiratory distress syndrome drugs.
FDA sent an untitled letter to Ony objecting to web pages and “blurry” video text that imply its lung surfactant is superior to competing products and minimizes Infasurf’s risks; Ony sued Cornerstone last year over its superiority claims.
Discovery Labs delays the commercial launch of its RDS drug Surfaxin until 2Q 2013, but continues to look for an international partner for the rest of its pipeline. The company assures investors that the delay is not indicative or safety or efficacy problems.
- Therapeutic Areas
- North America
- Parent & Subsidiaries
- Ony Inc.
- Senior Management
- Edmund Egan, MD, Pres.
- Contact Info
Phone: (716) 636-9096
Baird Research Park, 1576 Sweet Home Rd.
Amherst, NY 14228
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