Attached is a letter from Jan Cunningham, Dechra’s Director of Regulatory Affairs, North America, explaining the Mirataz®(mirtazapine transdermal ointment) shelf life extension, from 30 months to 48 months, which was approved by FDA in October 2019. The letter includes information on the product lots, the original labeled expiration dating and the new extended expiration dating, as well as details on four product lots that will be over-labeled with new expiration dating by Dechra.
It’s likely many of Mirataz veterinarians are not aware of FDA’s approval of a shelf life extension and may have questions about product in their clinics that appears to be expiring next month. The initial product lots manufactured by KindredBio (NCER, NCBF, NCCA) have an original expiration date of August 2020, which was 30 months from the date of manufacture. With FDA’s approval of an extended 48-month shelf life, the new expiration date is now February 2022 for product originally labeled with an August 2020 expiry. Please read the attached letter for complete details on all product lots and their new expiration dates.