Home » FDA: Axcan Must Address Deficiencies at Its Drug Manufacturer
FDA: Axcan Must Address Deficiencies at Its Drug Manufacturer
In a letter issued by the U.S. Food and Drug Administration in response to Axcan Intermediate
Holdings’ New Drug Application for Ultrase MT, the FDA requires thatdeficiencies
raised about the manufacturing and control processes at the manufacturer of the drug’s active ingredient
be addressed before approval can be granted.
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