Drug Approval | December 12, 2022
Zydus receives USFDA approval to market Silodosin and Pregabalin capsules
Silodosin capsules treat signs and symptoms of an enlarged prostate gland
Silodosin capsules treat signs and symptoms of an enlarged prostate gland
Expressed happiness that more than 30 countries of the world have given recognition to Ayurveda as a traditional system of medicine
As per 10th edition of International Diabetes Federation (IDF) Atlas, 2021, India has 74.2 million people with diabetes between the age of 20-79 years
The approval follows the positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in October 2022
GMP-compliant documentation of all manufacturing steps for cell and gene therapies
Move to increase affordability and accessibility for heart failure patients across the country
Application includes data from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary efficacy endpoints
Results showed a statistically significant and clinically meaningful improvement in investigator-assessed progression-free survival
Topiramate Extended-Release capsule had annual sales of US $68.8 mn in the United States according to IQVIA data (IQVIA MAT Sep 2022)
This product is based on Osmotic Controlled Release Oral Delivery System technology
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