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Ony Inc.

Latest From Ony Inc.

Celebrex Generics: Will Any Qualify For 180-Day Market Exclusivity?

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.

BioPharmaceutical United States

FDA Declares Pox On Both Houses In Enforcement Letters For Curosurf, Infasurf

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.

BioPharmaceutical United States

Ony Infasurf Claims Dinged By FDA After Firm Challenges Rival’s Study

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.

BioPharmaceutical Regulation

For Discovery’s Surfaxin, Another Delay

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.

BioPharmaceutical Launches
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Company Information

  • Industry
  • Pharmaceuticals
  • Therapeutic Areas
  • Non-Specific
  • Alias(es)
  • Ownership
  • Private
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Ony Inc.
  • Senior Management
  • Edmund Egan, MD, Pres.
  • Contact Info
  • Ony Inc.
    Phone: (716) 636-9096
    Baird Research Park, 1576 Sweet Home Rd.
    Amherst, NY 14228