Adempas fda approval date?

What is Adempas, and when was it first approved by the FDA?

Adempas (riociguat) received FDA approval on October 8, 2013 for the treatment of pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH), in categories specified by the label. [1]

Has the FDA approved Adempas for additional indications since then?

FDA approval dates for label expansions or supplemental approvals can differ from the original “first approval” date. If you want, tell me the specific indication you mean (PAH vs. CTEPH, or any subgroup), and I can help pin down the relevant FDA action date.

Why is the approval date important for patients or researchers?

The original FDA approval date is often used for timelines around market entry, post-marketing commitments, and when newer studies or label updates become relevant compared with the initial approval review. [1]

Sources

[1] https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204163