ANDA suitability petitions
Executive Summary
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.
You may also be interested in...
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.