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FDA actions in brief
FDA approved ranolazine extended-release tablets (Ranexa, CV Therapeutics) on January 31, 2006, for the treatment of chronic angina. A more thorough review of the agent will appear in the FDA Drug Approvals section of Formulary's March issue.
FDA approved ranolazine extended-release tablets (Ranexa, CV Therapeutics) on January 31, 2006, for the treatment of chronic angina. A more thorough review of the agent will appear in the FDA Drug Approvals section of Formulary's March issue.
An expanded indication was approved for bromfenac ophthalmic solution (Xibrom, Ista) to include the treatment of pain following cataract surgery.
Aprepitant (Emend, Merck) was approved to be used in combination with other antiemetic drugs to prevent nausea and vomiting associated with moderately emetogenic chemotherapy treatment.
The estradiol/levonorgestrel transdermal patch (Climara Pro, Berlex) was approved for the prevention of postmenopausal osteoporosis.
FDA approved lenalidomide (Revlimid, Celgene) for the treatment of patients with transfusion-dependent anemia resulting from low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
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.
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FDA Approves Stelara Biosimilar, Selarsdi
April 18th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
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