1 minute reading time (95 words)

KemPharm Announces FDA Approval of sNDA for Two Additional Strengths of APADAZ®

 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. Full story.

Want more pain resources? Check out our library of on-demand education, upcoming events, and more.

Learn More