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Adempas Approval History

FDA Approved: Yes (First approved October 8, 2013)
Brand name: Adempas
Generic name: riociguat
Dosage form: Tablets
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Pulmonary Hypertension

Adempas (riociguat) is an oral soluble guanylate cyclase (sGC) stimulator for the treatment of pulmonary hypertension.

Development History and FDA Approval Process for Adempas

DateArticle
Oct  8, 2013Approval FDA Approves Adempas to Treat Pulmonary Hypertension
Aug  6, 2013FDA Advisory Committee Unanimously Recommends Approval Of Bayer's Riociguat In Two Pulmonary Hypertension Indications
Apr  8, 2013Bayer's Investigational Riociguat Granted U.S. FDA Priority Review for Pulmonary Arterial Hypertension and Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension
Feb 12, 2013Bayer Submits New Drug Application for Riociguat for the Treatment of Pulmonary Arterial Hypertension and Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension

Further information

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