Recent FDA action (through April 2009) related to alglucosidase alfa, bosentan, cetuximab, doxepin, telavancin, quetiapine extended-release, oxycodone/niacin, and EUR-1073
Complete response
Priority review
Orphan drug designations
FDA Approves Combination Therapy for Pulmonary Arterial Hypertension
March 25th 2024J&J’s Opsynvi is single-tablet combination of macitentan, an endothelin receptor antagonist, and tadalafil, a PDE5 inhibitor. It will be priced on parity with Opsumit, which is also a J&J product to treat patients with PAH.