Bellport, N.Y. firm licenses five generic products -- propranolol, disopyramide, metoclopramide, clonidine, and tolazamide -- from Interpharm (Plainview, N.Y.). The ANDAs for metoclopramide, clonidine, and tolazamide have already been approved, and ANDA approval for disopyramide is expected within weeks, Patient Medical indicated.
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Unfounded expectation some firms have for FDA to protect their investments in preparing successful NDI notifications is part of industry’s overall interest in increased regulation of the market, says Steven Tave, Office of Dietary Supplement Programs director.