During the Health System Executive Summit, Candy Tsourounis, PharmD, and Elise Wozniak, PharmD got candid about the barriers and financial risk surrounding this innovative therapy.
News|Articles|January 1, 2009
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
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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.
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Related to this article
Foundational Pharmacy Strategies’ Christine Johnston on how rebate structures, pending legislation, and a stalled pipeline are reshaping — and threatening — the biosimilar market heading into 2027.
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