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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.

First reported by Mint 1 source
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  1. Mint

    Drug regulator halts obeticholic acid production, orders recall (opens Mint in a new tab)

    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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