United Therapeutics awaits FDA decision on oral PAH drug as Sandoz seeks generic approval

NEW YORK — The Food and Drug Administration is expected to decide at the end of this week whether to approve a new oral drug for pulmonary arterial hypertension made by United Therapeutics.

The FDA is scheduled to reach its decision this Saturday on United Therapeutics' treprostinil diethanolamine sustained-release tablets for PAH, a potentially fatal disease that causes high blood pressure in the blood vessels of the lungs, according to the company. The company already markets inhaled and injected formulations of the drug under the brand names Tyvaso and Remodulin, respectively.

Meanwhile, Sandoz, the generics arm of Swiss drug maker Novartis, is seeking to market a generic version of Remodulin. United Therapeutics filed a lawsuit against Sandoz in March after the generic drug maker filed for approval of generic treprostinil injection in the 10-mL-per-mg strength. Sandoz said three patents covering Remodulin are invalid, unenforceable or won't be infringed; United Therapeutics' lawsuit puts a stay of final FDA approval on the generic version for up to 30 months. The patents are scheduled to expire between 2014 and 2029, according to FDA records.


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