If they changed manufacturers, process, or components, then there are regulatory hurdles, but that has nothing to do with the drug
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Replying to @EmilyGorcenski
But the drug is already approved and the shortage reason listed is "Inactive Ingredient Shortage". This doesn't require reapproval
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Replying to @EmilyGorcenski
Pretty much every article I've read has put the holdup on the FDA due to slow approval after changing manufacturers.
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Replying to @Wrenegayd
The FDA's approval process is more or less predictable, so I don't understand that analysis.
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Replying to @EmilyGorcenski
The FDA isn't a sudden roadblock, it's a regulatory body with well-documented rules that get followed for every drug.
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Replying to @EmilyGorcenski
All talk about product being ready to ship and waiting on the FDA.
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Replying to @Wrenegayd
Par changed contract manufacturers and predicted the shortage of this and other drugs in an SEC filing in 2013.
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Replying to @EmilyGorcenski
But Perrigo didn't comment. Perrigo updated their status today, that's who I'm referring to.
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Replying to @EmilyGorcenski
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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Replying to @Wrenegayd
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.
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