FDA actions in brief
FDA approved the etonogestrel 68-mg implant (Implanon, Organon), a single-rod implantable device that prevents pregnancy for up to 3 years.
FDA approved the etonogestrel 68-mg implant (Implanon, Organon), a single-rod implantable device that prevents pregnancy for up to 3 years.
FDA approved rivastigmine (Exelon, Novartis) as the first treatment for mild-to-moderate dementia associated with Parkinson disease.
Bevacizumab (Avastin, Genentech) was approved in combination with intravenous 5-fluorouracil (5-FU)-based chemotherapy for the treatment of second-line metastatic colorectal cancer. The agent had been previously approved for first-line treatment of metastatic colorectal cancer in combination with IV 5-FU-based chemotherapy.
A topical anesthetic peel, packaged as a lidocaine 7%/tetracaine 7% cream formulation (Zars Pharma), was approved to be used prior to various superficial dermatologic procedures.
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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