Drug Approval | June 12, 2022
Strides receives USFDA approval for Ibuprofen OTC oral suspension
Strides was granted a Competitive Generic Therapy (CGT) designation for its ANDA.
Strides was granted a Competitive Generic Therapy (CGT) designation for its ANDA.
Dupixent is the first and only biologic medicine approved to treat moderate-to-severe atopic dermatitis from infancy to adulthood
he approved product has an estimated market size of US$ 83 million for the twelve months ending April 2022, according to IQVIA.
The drug will be manufactured at the group’s topical facility at Ahmedabad
Dupixent would be the first and only medicine specifically indicated to treat prurigo nodularis in the U.S., if approved
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Motrin Oral Suspension, 100 mg/5 mL, of McNeil Consumer Healthcare (McNeil)
The inspection was a Pre-Approval cum cGMP inspection and it covered 15 ANDAs
Opdivo-based treatments are now approved for five indications in upper gastroesophageal cancers
68% of patients receiving Kymriah in the ELARA trial experienced a complete response, with an 86% overall response rate, along with a remarkable safety profile
Perrigo expects to launch Omeprazole Minis later this year
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