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1783 News Found

Unichem Laboratories receives ANDA approval for Carbamazepine Tablets
Drug Approval | August 24, 2022

Unichem Laboratories receives ANDA approval for Carbamazepine Tablets

Carbamazepine Tablets are indicated for use as an anticonvulsant drug and in the treatment of the pain associated with true trigeminal neuralgia


Eugia Pharma receives USFDA pproval for Medroxyprogesterone Acetate injectable suspension
Drug Approval | August 24, 2022

Eugia Pharma receives USFDA pproval for Medroxyprogesterone Acetate injectable suspension

The approved product has an estimated market size of around US $62 million for the twelve months ending June 2022 according to IQVIA


USFDA grants emergency use authorization for Novavax COVID-19 vaccine
Drug Approval | August 22, 2022

USFDA grants emergency use authorization for Novavax COVID-19 vaccine

Novavax' vaccine is the first protein-based COVID-19 vaccine authorized in the U.S.


Ascletis announces IND approval of Oral RdRp Inhibitor ASC10 for COVID-19 by China NMPA
Drug Approval | August 22, 2022

Ascletis announces IND approval of Oral RdRp Inhibitor ASC10 for COVID-19 by China NMPA

Ascletis is China's first biotech company which has obtained IND approvals of an oral RdRp inhibitor from both China NMPA and the U.S. FDA


Swissmedic approves Kapruvia with additional regulatory decisions expected in H2 2022
Drug Approval | August 20, 2022

Swissmedic approves Kapruvia with additional regulatory decisions expected in H2 2022

Therapy recently approved in Canada under the brand name KORSUVA


Strides receives USFDA approval for Naproxen Sodium OTC Softgel capsules
Drug Approval | August 19, 2022

Strides receives USFDA approval for Naproxen Sodium OTC Softgel capsules

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Naproxen Sodium Capsules, 220 mg, of Bionpharma


Lupin receives approval from U.S. FDA for Rufinamide Tablets USP
Drug Approval | August 19, 2022

Lupin receives approval from U.S. FDA for Rufinamide Tablets USP

The product will be manufactured at Lupin's facility in Goa, India.


NATCO announces tentative approval to its ANDA for Trabectedin
Drug Approval | August 18, 2022

NATCO announces tentative approval to its ANDA for Trabectedin

According to industry sales data, Yondelis generated annual sales of $49.7 million for the twelve months ending June 2022 in the US market.


FDA accepts submission of olaparib in combination with abiraterone and prednisone for prostate cancer
Drug Approval | August 17, 2022

FDA accepts submission of olaparib in combination with abiraterone and prednisone for prostate cancer

First PARP inhibitor to demonstrate clinical benefit in radiographic progression-free survival in combination with a new hormonal agent with or without homologous recombination repair gene mutations


Lupin receives approval from U.S. FDA for Meclizine Hydrochloride Tablets USP
Drug Approval | August 16, 2022

Lupin receives approval from U.S. FDA for Meclizine Hydrochloride Tablets USP

Meclizine Hydrochloride Tablets had estimated annual sales of USD 29 million in the U.S.