Drug Approval | June 23, 2022
Menarini Group and Radius Health submit new drug application to the USFDA for Elacestrant
Intended for potential treatment of ER+/HER2- advanced or metastatic breast cancer patients
Intended for potential treatment of ER+/HER2- advanced or metastatic breast cancer patients
U.S. FDA has issued Form 483 with six observations after an inspection of the company’s formulation manufacturing facility based out of Baddi
Dasatinib Tablet is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive
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
Subscribe To Our Newsletter & Stay Updated
