RE:ANDA Sep. 2023 Solid, the September 2023 was a typo, and should have read September 2022. Why the company did not issue a correction is beyond me, but the press release was made public on August 1, 2023 which of course is a month prior to September 2023.
It was during the fall of 2022, that several Pharmacos filed ANDAs with the FDA related to Epidiolex as the initial exclusivity (NCE-1) date expired Sept 28 2022
TORONTO, Aug. 1, 2023
This was initiated in relation to MediPharm's Cannabidiol Active Pharmaceutical Ingredient (API) Drug Master File (DMF) being referenced in an Abbreviated New Drug Application (ANDA) submitted to the FDA in September 2023 by a global pharmaceutical company.