The FDA approved seven new drugs during December 2019, bringing the total new approvals for the year to forty-four. During the month the agency took another nineteen actions.
There are two investigational drugs with PDUFA Dates in January: Aimmune Therapeutics’ AR101 for Peanut Allergy and Epizyme’s Tazemetostat for Epithelioid sarcoma. AR101 has three FDA Priority Designations: Orphan Drug, Breakthrough Therapy, and Fast Track.
For a complete review of January’s potential blockbusters order Prescribe Right’s Pharmacy & Therapeutics Committee Forecast (PDF document and slides). The current forecast coverage period is January 1, 2020 through March 31, 2020.
Each forecast contains a review of investigational drugs with PDUFA Dates during each calendar quarter. Contents include generic name, brand name (if available), mechanism of action, ADRs, route, indication(s), PDUFA Date, FDA Priority Designations (if any), efficacy and a general comment from our Founder and CEO Scot Walker, PharmD, MS, BCPS, BCACP.
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Seven New December Approvals
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