Drug Approval | August 31, 2022
This launch builds upon Hikma’s leading position as one of the largest US providers of nasally administered medicines used for treating seasonal allergies and advances its objective of growing its specialty business in the US
Dasatinib Tablets (RLD Sprycel) had estimated annual sales of USD 1569 million in the U.S. (IQVIA MAT June 2022).
The RRA was conducted from 22nd August, 2022 to 26th August, 2022.
The unit has filed 2 Derma products and 1 MDI product.
he approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Hygroton Tablets, 25 mg and 50 mg, of Sanofi Aventis US. LLC (Sanofi).
This industry-academia collaboration will provide students with an opportunity to participate in research activities with multiple international universities and scientists
Indonesia national agency for drug and food control, BPOM, approved QDENGA for use in individuals 6 to 45 years of age
Pending authorization, Moderna ready to ship bivalent booster mRNA-1273.222 in September
There are no data integrity (DI) observations.
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