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FDA grants orphan drug designation for rofecoxib for treating hemophilic arthropathy

November 22, 2017

Tremeau Pharmaceuticals Inc. announced the FDA has granted orphan drug designation, on a first cycle review, for rofecoxib, a COX-2 selective non-steroidal anti-inflammatory drug for treatment of patients with hemophilic arthropathy.

“Being granted an orphan drug designation for rofecoxib (TRM-201) by FDA is an important regulatory milestone for Tremeau and affirms our strategy of providing non-opioid pain treatments for rare diseases like hemophilic arthropathy,” Bradford C. Sippy, CEO of Tremeau, said in the release. “Combined with our ongoing conversations with FDA of our proposed development plan for rofecoxib, we are well positioned to move forward with the development and introduction of rofecoxib for this specific use.”

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Resource Centers
American Association of Hip and Knee Surgeons Annual Meeting

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