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Drug regulator halts obeticholic acid production, orders recall

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Drug regulator halts obeticholic acid production, orders recall
Photo / Coverage: Livemint - News
EXECUTIVE SUMMARY

The DCGI has sought the cancellation of manufacturing licences for obeticholic acid (5mg and 10mg tablets), used to treat primary biliary cholangitis (PBC), following similar actions by the US FDA and the European Medicines Agency.

Key Takeaways

  • Drug regulator halts obeticholic acid production, orders recall.

The DCGI has sought the cancellation of manufacturing licences for obeticholic acid (5mg and 10mg tablets), used to treat primary biliary cholangitis (PBC), following similar actions by the US FDA and the European Medicines Agency.

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