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
This product is based on Osmotic Controlled Release Oral Delivery System technology
The product is expected to be launched by Q4 FY23.
The approval further strengthens the Potassium Chloride franchise for the company.
The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India
Ketorolac Tromethamine is advised for the short-term management of moderately severe acute pain in adult patients
Mesalamine Extended-Release Capsules are indicated for the maintenance of remission of ulcerative colitis in adults.
This is the first injectable product approval from our General Sterile Facility (F-3) which was inspected in August, 2022.
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Naproxen Sodium Capsules, 220 mg, of Bionpharma
The approved product has an estimated market size of around US$ 606 million for the twelve months ending June 2022, according to IQVIA.
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