Press Release29 Apr 2024, 02:37 pm
Glenmark Pharmaceuticals Obtains ANDA Approval for Acetaminophen and Ibuprofen Tablets
AI Summary
Glenmark Pharmaceuticals Ltd. has received approval from the US Food & Drug Administration (FDA) for its Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC). These tablets are determined to be bioequivalent to Advil® Dual Action with Acetaminophen Tablets. According to Nielsen® syndicated data, the Advil® Dual Action market achieved annual sales of approximately $84.1 million in the latest 52-week period. Glenmark plans to distribute these tablets in the US through Glenmark Therapeutics Inc.
Key Highlights
- Glenmark receives FDA approval for Acetaminophen and Ibuprofen Tablets
- Approval based on FDA finding of bioequivalence to Advil® tablets
- Glenmark Therapeutics to distribute the approved tablets in the US
- Advil® market achieved annual sales of approximately $84.1 million in the latest 52-week period
- Glenmark's US portfolio now includes 195 products and 52 pending ANDA's