Drug Approval | September 01, 2022
Zydus receives final approval from USFDA for two tablets
The group now has 322 approvals and has so far filed over 428 ANDAs since the commencement of the filing process in FY 2003-04
The group now has 322 approvals and has so far filed over 428 ANDAs since the commencement of the filing process in FY 2003-04
The observations primarily relate to the need for improving strategies for microbial control, enhancing quality oversight, augmenting the use of software applications & computerized tools
India is at the forefront of research in cardiology worldwide but making indigenous products is what we are lacking & it needs to be improved
Dr. Pedrocchi is currently an Independent Strategic Advisor and Non-Executive Director to private and public healthcare companies.
Chlorthalidone Tablets USP, 25 mg and 50 mg, have an estimated market size of US $37 million for twelve months ending June, 2022 according to IQVIA
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
The Phase IV DREAM-CKD trial will enrol 1004 CKD patients in India, including 502 dialysis dependent, 502 dialysis independent CKD patients with anemia.
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).
Dasatinib Tablets (RLD Sprycel) had estimated annual sales of USD 1569 million in the U.S. (IQVIA MAT June 2022).
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