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FDA Actions in Brief August 2010 (Tribenzor, Daiichi Sankyo, Aricept, Eisai and Pfizer, Daytrana, Glassia, Zuplenz, Infergen, Cuvposa)
Recent FDA Approvals (through July 2010) related to Tribenzor, Daiichi Sankyo, Aricept, Eisai and Pfizer, Daytrana, Glassia, Zuplenz, Infergen, Cuvposa
Olmesartan medoxomil, amlodipine, hydrochlorothiazide (Tribenzor, Daiichi Sankyo) was approved for the treatment of uncontrolled hypertension.
A once-daily, higher-dose donepezil HCl (Aricept, Eisai and Pfizer) 23-mg tablet was approved for the treatment of moderate-to-severe Alzheimer's disease.
Methylphenidate transdermal system (Daytrana, Shire) was approved for the treatment of attention deficit hyperactivity disorder in adolescents aged 13 to 17 years.
Ondansetron (Zuplenz, Strativa) was approved for the prevention of postoperative, highly and moderately emetogenic cancer, chemotherapy-induced, and radiotherapy-induced nausea and vomiting.
Consensus Interferon (Infergen, Three Rivers Pharmaceuticals) expanded labeling was approved to include daily use in combination with ribavirin for the retreatment of chronic hepatitis C patients.
Glycopyrrolate (Cuvposa, Shionogi Pharma) oral solution was approved for the treatment of chronic severe drooling caused by neurologic disorders in children aged 3 to 16 years.
FDA Approves Pfizer’s Gene Therapy for Beqvez for Hemophilia
April 26th 2024Beqvez (fidanacogene elaparvovec) is priced at $3.5 million, which is on parity with Hemgenix, the first one-time therapy to treat adults with hemophilia B. Pfizer’s warranty will refund insurers and continue to provide coverage for patients if they change insurers.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
