Duramed

Withdraws three approved ANDAs after FDA notifies company that the agency would begin proceedings to withdraw approval of the applications. The announcement of the withdrawal in the Feb. 21 Federal Register states that FDA "became aware of untrue statements, discrepancies, and omissions" relating to the ANDAs for prochlorperazine maleate tabs, 5 mg, 10 mg, and 25 mg. All three dosage strengths were part of a five-product recall by Duramed in January ("The Pink Sheet" Jan. 21, T&G-11).