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
Longer-term survival results underscoring role of KEYTRUDA (pembrolizumab) in multiple cancer types, including advanced nonsquamous non-small cell lung cancer (KEYNOTE-189)
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).
To mark the occasion, Integrated Pharmaceutical Database Management System 2.0 (IPDMS 2.0), an integrated responsive cloud-based application developed by NPPA with technical support from C-DAC will be launched
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.
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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