Roxane's acetaminophen/codeine
Executive Summary
Acetaminophen 500 mg and codeine phosphate 15 mg, 30 mg or 60 mg tablets are ANDA suitable. The listed drugs are McNeil's Tylenol with codeine #2, #3, and #4 (acetaminophen 300 mg and codeine phosphate 15 mg, 30 mg and 60 mg) tablets.
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.