ANDA suitability petitions
FDA denied Purdue Frederick's request for ANDA suitability of choline magnesium trisalicylate 500 mg with codeine phosphate 30 mg or 60 mg in tabs. FDA said the product is not suitable for an ANDA because choline magnesium trisalicylate has never been approved either as a single agent or in combination with another active ingredient. FDA also denied Ciba Consumer Pharmaceutical's petition requesting ANDA suitability for dextromethorphan hydrobromide 60 mg controlled release tabs, stating that the product is a new salt of dextromethorphan polistirex. FDA noted that while several dextromethorphan hydrobromide products are currently marketed under pre-1962 standards, the agent has not yet been proven effective.
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