Intellipharmaceutics Receives Complete Response Letter from the FDA for Rexista™ NDAP&T Community
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These can include higher dosages of both fast-acting, immediate-release opioids as well as slow-acting, longer-release formulations of oxycodone, hydromorphone, morphine, oxymorphone, hydrocodone, methadone and fentanyl.
The petition specifically requests the removal of OxyContin 80mg, which when taken twice a day equals 240 MME in 24 hours, as well as the removal of oxycodone 30mg, typically taken four times a day for the (more…)
July 27, 2017
The safety committees noted safety concerns regarding the extended-release tablets ability to prevent abuse or misuse as a reason not to recommend approval of the NDA.
In a vote of 22 to 1, the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee of the FDA found that Intellipharmaceutics International Inc’s New Drug (more…)