Drug Approval | June 12, 2022
Alembic receives USFDA tentative approval for Dasatinib tablets
Dasatinib Tablet is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive
Dasatinib Tablet is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive
The tablets have an estimated market size of US $ 548 million for twelve months ending December 2021 according to IQVIA
This ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies
Docosanol Cream, 10% (OTC) has an estimated market size of US$60 million for twelve months ending December 2021 according to IQVIA
Clobetasol Propionate Foam, 0.05% has an estimated market size of US $ IO million for twelve months ending Dec 2021 according to IQVIA
Ivabradine Tablets, 5 mg and 7.5 mg have an estimated market size of US $ 102 million for twelve months ending December 2021 according to IQVIA
Lidocaine and Prilocaine Cream USP, 2.5%/2.5% has an estimated market size of US $ 29 million for twelve months ending Dec. 2021 according to IQVIA
The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Pradaxa Capsules of Boehringer lngelheim
The tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older
Macitentan tablets, 10 mg have an estimated market size of US $ 797 million for twelve months ending Dec 2021 according to IQVIA
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