Epidiolex ANDA. US FDA Status Update
MediPharm completed a US FDA five day in-person inspection from November 21 to 25, 2022. 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. Following the inspection, MediPharm was presented with inspection observations. MediPharm has responded in writing to all observations via a corrective action plan. These actions have now been implemented and any additional FDA feedback is expected by way of comments on the Company’s DMF and partner’s ANDA filings. As this process is completed, MediPharm continues to be a registered foreign drug manufacturing site with the US FDA. The company believes it is the only Canadian Pharmaceutical company or LP with this registration. If the brand product sponsor or patent holder files an infringement suit against the generic applicant within 45 days of the ANDA notification, FDA approval to market the generic drug is generally postponed for 30 months unless the patent expires or is judged to be invalid or not infringed before that time.