Organization: Health Canada
Year: 2022
Month: March
Request Number: A-2021-001941
Request Summary: All communications between Janssen Inc., Janssen Ortho Inc. and their affiliates, Janssen’s agents or counsel, or Innovative Medicines Canada, its agents or counsel, and Health Canada, (including but not limited to the Office of Patented Medicines and Liaison (OPML) and the Central Nervous System Division (CNSD)) relating to: the product monograph for Apotex’s generic version of INVEGA SUSTENNA; and the degree of similarly and allowed difference between the product monograph for INVEGA SUSTENNA (the Canadian Reference Product) and the product monograph for Apotex’s generic drug product, including with respect to recommended dosing of the drug.
Disposition: No records exist
Number of pages: 0