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Monday, January 7, 2019

KemPharm: FDA approves Apadaz sNDA for two additional strengths


KemPharm announced today that the FDA has approved a supplemental new drug application, or sNDA, for two additional strengths of Apadaz, an immediate release combination of KemPharm’s prodrug, benzhydrocodone, and acetaminophen, or APAP. The approval of these new dosage strengths, 4.08 mg benzhydrocodone/325 mg APAP and 8.16 mg benzhydrocodone/325 mg APAP, follows the NDA approval on February 23, 2018 of the 6.12 mg benzhydrocodone/325 mg APAP dosage strength of Apadaz.

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