Drug Approval | September 25, 2023
Strides receives USFDA approval for Icosapent Ethyl Capsules
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD)
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD)
The companies will work with investigators to share the results with the scientific community
Clindamycin Phosphate Gel is used to treat acne
InvaGen has received 5 inspectional observations in Form 483
Norepinephrine Bitartrate Injection is used for restoration of blood pressure in adult patients
Opinion granted based on positive disease-free survival results from the Phase 3 KEYNOTE-091 trial
Norelgestromin and Ethinyl Estradiol Transdermal System, 150 mcg/35 mcg per day had annual sales of US $330 million in the United States
Approval of this product under the PEPFAR program completes Strides’ qualification to all major markets and donor programs including Global Fund and South Africa
The products will be manufactured at the company's facility in Bengaluru
The company has received the Establishment Inspection Report (EIR) from the USFDA for the Pre-Approval Inspection (PAI) at a manufacturing site situated at Savli, Vadodara, Gujarat, with Zero 483 observations
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