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Johnson & Johnson (J&J) subsidiary McNeil Consumer Healthcare is modifying some of its packaging equipment after blister unit tears led to a recall of one lot, 53,892 packages, of diarrhea drug Imodium from wholesalers.
Meeting specific review goals for drugs and biologics is generally not a criterion in FDA reviewers’ performance plans, according to a Government Accountability Office (GAO) report requested by Congress.
The FDA has warned Quadex Pharmaceuticals that its cold sore treatment Viroxyn Professional was never approved as a new drug and does not conform to the formulation and labeling requirements for an OTC cold sore drug.
Actavis is launching generic versions of GlaxoSmithKline’s (GSK) Parkinson’s disease drug Requip XL and believes they are the first in the U.S.
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