Intellipharmaceutics International (NASDAQ: IPCI; TSX: I) is engaged in the research, development, and commercialization of controlled-release and targeted-release pharmaceutical products. Controlled-release means releasing a drug into the bloodstream or at a target site in the body, over an extended period of time or at predetermined times. In some circumstances, controlled-release drug delivery can enhance efficacy and patient compliance as compared to immediate release formats for the same drug.
With the FDA informing Shire on June 22, 2012 that it has approved the ANDA for generic Adderall XR filed by Actavis this certainly bodes well for Intellipharmaceutics’ generic Focalin XR for ADHD. IPCI has a strategic alliance with Par Pharmaceutical (NYSE: PRX) for generic Focalin XR who has publicly stated that they have a date certain launch of October 2012, assuming FDA approval on or before this date. IPCI has publicly stated that obtaining Focalin XR approval is a 2012 goal.
According to the Shire press release:
"The FDA’s response requires that all abbreviated new drug applications ( ANDAs) have to establish bioequivalence using partial area under the curve measurements at 5 hours and beyond 5 hours, for both d- and l- amphetamine. The FDA response is consistent with its recent decisions on other long acting ADHD products."