Recent data were released on a long-term, open-label extension study evaluating clobazam for the adjunctive treatment of drop seizures.
A leading epidemiologist recently suggested alternative treatments for the fungal meningitis outbreak late last year. To date, 46 deaths have been linked to contaminated steroids from compounding pharmacies.
FDA has approved vincristine sulfate liposome injection for the treatment of adult patients with Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia (ALL) who have had at least two relapses or whose disease has progressed following two or more anti-leukemia therapies.
Novartis has agreed with FDA to update US prescribing information on fingolimod (Gilenya) to include updated patient selection parameters based on certain cardiovascular considerations to aid in the identification of candidates for Gilenya.
FDA added new label warnings for the antidepressant citalopram (Celexa, Forest Laboratories), discouraging patients with certain conditions from using the drug and lowering the dosage recommendations to 20 mg daily for patients aged 60 and older. The warning is also applicable to generic versions of Celexa.
FDA has approved peginesatide (Omontys, Affymax) to treat anemia in adult dialysis patients who have chronic kidney disease (CKD).
Teva/IVAX Pharmaceuticals gained FDA approval for the first generic version of Lexapro (Forest) to treat both depression and generalized anxiety disorder in adults. The company will have 180 days to exclusively sell the product.
FDA approved the first cell-based product made from allogeneic human cells and bovine collagen (Gintuit, Organogenesis) for the treatment of oral mucogingival conditions in adults, the agency announced Friday.