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Biotechnology company United Therapeutics Corporation (NasdaqGS:UTHR) said on Thursday that the US Food and Drug Administration (FDA) has accepted the resubmission of the new drug application (NDA) for treprostinil diolamine extended release tablets (oral treprostinil).
These treprostinil diolamine extended release tablets (oral treprostinil) are reportedly indicated for the treatment of pulmonary arterial hypertension, stated the company.
Diolamine, potassium sodium tartrate, disodium 4-nitrophenylphosphate, Triton X-100, and 4-nitrophenol were domestic AR grade.