Recent FDA approvals (through April 2010) related to Silenor, Carbaglu, Hizentra, Norditropin FlexPro, Xifaxan, Differin, Botox
Doxepin (Silenor, Somaxon) for the treatment of insomnia characterized by difficulty with sleep maintenance.
Carglumic acid (Carbaglu, Orphan Europe) tablets for the treatment of N-acetylglutamate synthase or NAGS deficiency, that results in too much ammonia in the blood.
Immune globulin subcutaneous (human), 20% liquid (Hizentra, CSL Behring) for the treatment of patients diagnosed with primary immunodeficiency.
Rifaximin (Xifaxan, Salix) for the reduction in the risk of the recurrence of overt hepatic encephalopathy in patients with advanced liver disease.
Adapalene (Differin, Galderma) Lotion, 0.1% for the treatment of acne.
Onabotulinumtoxin A (Botox, Allergan) for the treatment of spasticity in the flexor muscles of the elbow, wrist, and fingers in adults. Spasticity is common after stroke, traumatic brain injury, or the progression of multiple sclerosis.
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.