Wednesday, July 24, 2019 10:10:26 PM
I take this to mean no new opioid approvals until further notice, at least in regards to NDA's. This PR is coming from IPCI and not FDA, but these words are in quotes, presumably from a letter from FDA: “is postponing product-specific advisory committee meetings for opioid analgesics,” ... “while it continues to consider a number of scientific and policy issues relating to this class of drugs.”
No AdComm --> No approval
This is probably good for IPCI. They could have been torn up at AdCom for most likely poor results on chewing HAL studies, with subsequent CRL crash. But now the application goes to purgatory. Instead of a two-time loser, they still have a potential asset in the form of a pending NDA, for who knows how long.
An interesting coincidence(?): on July 22, FDA approved the first nine ANDA's for generic Lyrica, a non-opioid analgesic.
Go ELTP.
Long & Strong.
Call on God but row away from the rocks.
-Hunter S. Thompson
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