PAH Market Heats Up: New Approvals For Actelion, United Therapeutics
With a Risk Evaluation and Mitigation Strategy for Tracleer now approved by FDA, Actelion can maximize the drug's selling potential across a broader range of pulmonary arterial hypertension patients before it faces generics in 2015
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While still much less frequent than GMP warning letters, PADE letters are on the rise, with FDA focusing on reports for drugs with known serious safety issues.
Lee's Pharmaceutical In-Licenses United Therapeutics' Pulmonary Arterial Hypertension Treatment Remodulin In China
SHANGHAI - Hong Kong-based Lee's Pharmaceutical and U.S.-based United Therapeutics signed an agreement for the distribution of United Therapeutics' pulmonary arterial hypertension treatment Remodulin (treprostinil) in China, despite a recent setback for the drug's launch in Europe
Discussions on sodium oxybate likely to stray into effectiveness of current risk management measures for company's narcolepsy drug Xyrem, which contains the same active ingredient.