Posted by Michael Wonder on 07 Jan 2019
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)
7 January 2019 - Apadaz now approved in three dosage strengths, providing greater flexibility to prescribers through additional dosing options.
KemPharm announced today that the U.S. FDA has approved a supplemental new drug application for two additional strengths of Apadaz, an immediate release 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 approval on February 23, 2018 of the 6.12 mg benzhydrocodone/325 mg APAP dosage strength of Apadaz.
