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Altavant Sciences Provides Update on Clinical Plan for PAH Candidate, Rodatristat Ethyl, at Upcoming American Thoracic Society Annual Meeting
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CARY, N.C. and BASEL, Switzerland, May 10, 2021 /PRNewswire/ Altavant Sciences, a clinical-stage biopharmaceutical company focused on patient-centric drug development in rare respiratory diseases, will be providing an update on the clinical development of rodatristat ethyl, the company s lead candidate for the treatment of pulmonary arterial hypertension (PAH), at the annual meeting of the American Thoracic Society (ATS), being held virtually on May 14-19, 2021.
Altavant is conducting a randomized, double-blind Phase 2b clinical study of rodatristat in up to 90 adults with PAH. The study, ELEVATE 2 (NCT04712669), is randomizing participants to receive one of two doses of rodatristat ethyl or placebo twice daily for 24 weeks. Altavant s study design for ELEVATE 2 is based, in part,
Zydus Cadila has received final approval from the USFDA to market Macitentan Tablets, 10 mg (US RLD: Opsumit Tablets). Macitentan is used to manage the symptoms of pulmonary arterial hypertension.
Macitentan is in a class of medications called endothelin receptor antagonists. It works by stopping the action of endothelin, a natural substance that causes blood vessels to narrow and prevents normal blood flow in people who have Pulmonary Arterial Hypertension.
According to the USFDA letter, Zydus was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Macitentan Tablets, 10 mg. Therefore, with this approval, Zydus is eligible for 180 days of shared generic drug exclusivity for Macitentan Tablets, 10 mg.
Zydus Cadila announces final USFDA approval for Macitentan Tablets, 10 mg and gets eligibility for 180-day shared exclusivity
Posted On: 2021-04-07 21:48:12 (Time Zone: Arizona, USA)
Zydus Cadila has received final approval from the USFDA to market Macitentan Tablets, 10 mg (US RLD: Opsumit Tablets). Macitentan is used to manage the symptoms of pulmonary arterial hypertension. Macitentan is in a class of medications called endothelin receptor antagonists. It works by stopping the action of endothelin, a natural substance that causes blood vessels to narrow and prevents normal blood flow in people who have Pulmonary Arterial Hypertension.
According to the USFDA letter, Zydus was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Macitentan Tablets, 10 mg. Therefore, with this approval, Zydus is eligible for 180 days of shared generic drug exclusivity for Macitentan Tablets, 10 mg.
Cadila Healthcare rose 1.03% to Rs 466 after the pharma company announced that it has received final approval from the USFDA to market Macitentan Tablets, 10 mg.
Macitentan is used to manage the symptoms of pulmonary arterial hypertension. Macitentan is in a class of medications called endothelin receptor antagonists. The drug works by stopping the action of endothelin, a natural substance that causes blood vessels to narrow and prevents normal blood flow in people who have Pulmonary Arterial Hypertension.
According to the USFDA letter, Zydus was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Macitentan Tablets, 10 mg. Therefore, with this approval, Zydus is eligible for 180 days of shared generic drug exclusivity for Macitentan Tablets, 10 mg.