Trans folks: Perrigo updated the FDA drug shortage database today, and have release plans in October and November for 20 and 40 mg/mL doses.
Par changed contract manufacturers and predicted the shortage of this and other drugs in an SEC filing in 2013.
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But Perrigo didn't comment. Perrigo updated their status today, that's who I'm referring to.
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I see the update. My problem is this delay isn't seen as critical for approval by the FDA, which is ridiculous.
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I don't know how to respond to that, other than the FDA doesn't have a pathway for that, really. Blame rests on Par.
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The FDA process for modding a contract mfg takes 6-9 months, no matter what. They should have had supply to last.
End of conversation
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