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.
FDA Issues Complete Response for High-Dose Opioid Rescue Med
July 16th 2024OX124 is a nasal spray provides rapid absorption of naloxone for patients experiencing an opioid overdose. The FDA would like to see additional technical data, as well as data on whether patients can correctly use the device.
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