FDA actions in brief, January 2009 (Banzel, tapentadol, synthetic conjugated estrogens-A, Ranexa)
Recent FDA approvals (through January 2009) related to Banzel, tapentadol, synthetic conjugated estrogens-A, and Ranexa
Rufinamide (Banzel, Eisai) was approved for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in children aged ≥4 years and adults.
Tapentadol immediate-release tablets (Johnson & Johnson) were approved for the relief of moderate-to-severe acute pain in adults aged ≥18 years.
Synthetic conjugated estrogens-A (SCE-A) 0.625 mg/g vaginal cream (Duramed) was approved for the treatment of moderate-to-severe vaginal dryness and pain with intercourse.
Ranolazine (Ranexa, CV Therapeutics) was approved for the first-line treatment of chronic angina.
FDA Clears Phase 2 Trial of Cannabis in PTSD
November 20th 2024After a three-year negotiation, the FDA has dropped its objection to allowing patients to self-titrate dosing of smoked cannabis. But regulators want to see additional information about the device that will be used for inhalation.
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