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FDA Approval of sNDA for Two Additional Strengths of Apadaz

FDA Approval of sNDA for Two Additional Strengths of Apadaz2019.01.09

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 paramount to facilitating the potential replacement of other hydrocodone/APAP products currently available. We believe the timing of this sNDA approval is great news for a second half 2019 launch with our commercial partner, KVK-Tech,” said Travis Mickle, Ph.D., KemPharm’s President and Chief Executive Officer. “We believe the sNDA approval of the two additional strengths of Apadaz enhances the marketability, and ultimately the acceptance of the product, by offering physicians maximum flexibility when prescribing the product,” Dr. Mickle concluded.





Source: drugs.com


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