KemPharm Announces FDA Approval of sNDA for Two Additional Strengths of APADAZ® (4.08 mg benzhydrocodone/325 mg APAP and 8.16 mg benzhydrocodone/325 mg APAP)
KemPharm, Inc. (KMPH)
Last kempharm, inc. earnings: 2/28 07:30 am
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Source: GlobeNewswire
APADAZ® Now Approved in Three Dosage Strengths, Providing Greater Flexibility to Prescribers Through Additional Dosing Options CORALVILLE, Iowa, Jan. 07, 2019 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, announced today that the U.S. Food and Drug Administration (FDA) has approved a Supplemental New Drug Application (sNDA) for two additional strengths of APADAZ®, an immediate release (IR) combination of KemPharm’s prodrug, benzhydrocodone, and acetaminophen (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 New Drug Application (NDA) approval on February 23, 2018 of the 6.12 mg benzhydrocodone/325 mg APAP dosage strength of APADAZ. “When commercializing a new product in a very large market, such as with APADAZ, minimizing potential barriers for both physicians and health plans is paramoun
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