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 Approves Two More Denosumab Biosimilars, Conexxence and Bomyntra
March 27th 2025The fourth pair of denosumab biosimilars, Conexxence and Bomyntra, are expected to launch in the United States in mid 2025, as a result of a global settlement with Amgen, according to a company news release.
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FDA Approves First Drug for Excess Hunger in Prader-Willi Syndrome
March 27th 2025Vykat XR will be available in April to treat the intense hunger that is a hallmark of the rare genetic disease Prader-Willi syndrome. The price is based on a patient’s weight, and the average patient in the clinical trials would have had an average annual cost of $466,200 for the first year.
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FDA Approves Amvuttra for ATTR-CM in Extended Label
March 21st 2025This expanded indication for Amvuttra makes it the first and only FDA-approved treatment for transthyretin amyloidosis with cardiomyopathy (ATTR-CM) and the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults.
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