FDA actions in brief
Thalidomide (Thalomid, Celgene) was approved in combination with dexamethasone for the treatment of patients with newly diagnosed multiple myeloma.
Thalidomide (Thalomid, Celgene) was approved in combination with dexamethasone for the treatment of patients with newly diagnosed multiple myeloma.
FDA approved 2 higher dose formulations of valsartan/hydrochlorothiazide (Diovan HCT, Novartis) for the treatment of hypertension. The combination tablets will now be available in 320/12.5 mg and 320/25 mg doses.
FDA approved infliximab (Remicade, Centocor) to treat children aged 6 to 17 years with active Crohn's disease.
Navitus to Offer Unbranded Stelara Biosimilar, Remove Stelara from Formulary
March 13th 2025Lumicera Health Services, Navitus’ specialty pharmacy, has made a deal with Teva to offer an unbranded biosimilar that they estimate will save $112,000 and $336,000 per patient per year. Navitus will remove Stelara from formulary on July 1, 2025.
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FDA Approves Neffy 1 mg Nasal Spray for Pediatric Patients
March 6th 2025Neffy 1 mg is now approved by the FDA to treat pediatric patients who weigh 33 to 65 lbs. Neffy was first FDA-approved as a 2 mg dose in August 2024 for the emergency treatment of anaphylaxis in children and adults weighing at least 66 lbs.
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