USFDA22 May 2024, 05:18 pm
Zydus Lifesciences Gets Final Approval for Theophylline Extended-Release Tablets from USFDA
AI Summary
Zydus Lifesciences Ltd has received final approval from the USFDA to market Theophylline Extended-Release Tablets, 300 mg and 450 mg in the United States. The drug will be used to treat asthma and chronic obstructive pulmonary disease (COPD) and is expected to have annual sales of USD 12.6 mn. This marks the 396th approval for Zydus and they have filed over 460 ANDAs since the process began in FY 2003-04.
Key Highlights
- Zydus receives final approval for Theophylline Extended-Release Tablets, 300 mg and 450 mg from USFDA
- The drug will be used to treat asthma and COPD in the United States
- Annual sales are expected to be USD 12.6 mn
- This is the 396th approval for Zydus
- They have filed over 460 ANDAs since the filing process began in FY 2003-04