Endo’s Par Pharmaceutical is yanking one lot of its treprostinil injection from the U.S. market over concerns that silicone particles could be in vials of the drug. The batch of the pulmonary arterial ...
Dr. Reddy's is offering treprostinil injection, the generic of United Therapeutics' Remodulin. The medication is used to treat adults with pulmonary arterial hypertension, a type of high blood ...
A short induction of Remodulin® (treprostinil) injection allowed study subjects to reach double the typical doses of Orenitram® (treprostinil) extended-release tablets than patients who did not have a ...
SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., July 31, 2018 /PRNewswire/ -- United Therapeutics Corporation (NASDAQ: UTHR) today announced approval by the U.S. Food and Drug Administration (FDA ...
United Therapeutics reported first-quarter results above our and FactSet consensus expectations. Its treprostinil franchise for pulmonary arterial hypertension (PAH) remains fairly stable despite ...
A little more than a month after Par Pharmaceutical, a unit of Dublin's Endo International, yanked a batch of its Remodulin generics from U.S. shelves, the company is expanding its product pull. Par ...
Although it must conduct a Phase IV trial, United Therapeutics Corp. received FDA approval to market Remodulin for the treatment of pulmonary arterial hypertension in patients with New York Heart ...
Jan. 17, 2006 — Tolcapone tablets have been reintroduced in the UK market after a 7-year suspension by the European Medicines Evaluation Agency; the European Commission has approved orphan drug status ...
SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Oct. 11, 2021 /PRNewswire/ -- United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation with a purpose to provide a brighter ...
The FDA’s bright line between orphan designation and exclusivity was erased, again, Monday for some drugs when the U.S. Court of Appeals for the District of Columbia denied the agency an en banc ...