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8349 News Found

Medix Biochemica appoints former Roche executive to its Board of Directors
People | September 01, 2022

Medix Biochemica appoints former Roche executive to its Board of Directors

Dr. Pedrocchi is currently an Independent Strategic Advisor and Non-Executive Director to private and public healthcare companies.


Alembic Pharmaceuticals receives USFDA Final Approval for Chlorthalidone Tablets
News | August 31, 2022

Alembic Pharmaceuticals receives USFDA Final Approval for Chlorthalidone Tablets

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


Alembic Pharmaceuticals receives USFDA final approval for Chlorthalidone Tablets USP
Drug Approval | August 29, 2022

Alembic Pharmaceuticals receives USFDA final approval for Chlorthalidone Tablets USP

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).


Lupin receives tentative approval from USFDA for Dasatinib Tablets
Drug Approval | August 29, 2022

Lupin receives tentative approval from USFDA for Dasatinib Tablets

Dasatinib Tablets (RLD Sprycel) had estimated annual sales of USD 1569 million in the U.S. (IQVIA MAT June 2022).


Qdenga approved in Indonesia for use regardless of prior dengue exposure
Drug Approval | August 28, 2022

Qdenga approved in Indonesia for use regardless of prior dengue exposure

Indonesia national agency for drug and food control, BPOM, approved QDENGA for use in individuals 6 to 45 years of age


Granules India received ANDA approval for Guaifenesin and Pseudoephedrine Hydrochloride ER
Drug Approval | August 27, 2022

Granules India received ANDA approval for Guaifenesin and Pseudoephedrine Hydrochloride ER

Granules now have a total of 51 ANDA approvals from US FDA (49 Final approvals and 2 tentative approvals).


Lupin receives UK MHRA Approval of Lutio for treatment of COPD
Drug Approval | August 27, 2022

Lupin receives UK MHRA Approval of Lutio for treatment of COPD

Lutio has the potential to offer significant cost savings when available to UK patients.


Olaparib approved in Japan as adjuvant treatment for patients with high recurrent risk breast cancer
Drug Approval | August 26, 2022

Olaparib approved in Japan as adjuvant treatment for patients with high recurrent risk breast cancer

First and only PARP inhibitor to improve invasive disease-free survival, the primary endpoint, and overall survival, a key secondary endpoint of the OlympiA trial, in these patients