Aurobindo Pharma Generic Ambrisentan Receives Approval in the U.S.
CARY, N.C. and BASEL, Switzerland, May 6, 2022 /PRNewswire/ -- Altavant Sciences, a clinical-stage biopharmaceutical company focused on patient-centric drug development in rare respiratory diseases, announced today that the company is presenting results from a preclinical study comparing rodatristat ethyl as a monotherapy and in combination with the type A endothelin receptor antagonist, ambrisentan, in an animal model of pulmonary arterial hypertension (PAH). Results describing changes in post-hypoxia occlusions as well as mean pulmonary arterial pressure (mPAP) with each treatment regimen will be presented in a poster at ATS 2022 being held in San Francisco, CA, May 13-18, 2022.
The US Food and Drug Administration (FDA) has released a memorandum explaining why it waived the requirement of a single, shared system (SSS) risk evaluation and mitigation strategy (REMS) for generic versions of Gilead’s Letairis (ambrisentan), which treats pulmonary arterial hypertension. This is just the fourth time in FDA’s history that it has waived an SSS REMS for generic competitors.
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Roche, Novo Nordisk, Novartis reduce or cancel some increases. In the past three weeks, Novartis AG, Gilead Sciences Inc., Roche Holding AG and Novo Nordisk A/S sent notices to California health plans rescinding or reducing previously announced price hikes on at least 10 drugs.
In order to drive the manufacture of affordable generic drugs, the U.S.Food and Drug Administration is naming names of companies that have attempted to block competition.
But, the decision is based on data from the phase III/IV AMBITION study, which showed that the combination of Volibris (ambrisentan) and tadalafil reduced the risk of clinical failure by 50% in treatment-naïve PAH patients compared to pooled ambrisentan and tadalafil monotherapy