FDA actions in brief, April 2010 (Silenor, Carbaglu, Hizentra, Norditropin FlexPro, Xifaxan, Differin, Botox)


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.

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