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3813 News Found

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


Wockhardt announces successful initiation of Global Phase 3 Clinical Study of its novel antibiotic WCK 5222
Clinical Trials | August 16, 2022

Wockhardt announces successful initiation of Global Phase 3 Clinical Study of its novel antibiotic WCK 5222

WCK 5222 is a Super-drug which is entirely a new class of antibiotic known as "?-lactam ENHANCER".


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.


Eugia Pharma receives USFDA approval for Vasopressin Injection USP
Drug Approval | August 16, 2022

Eugia Pharma receives USFDA approval for Vasopressin Injection USP

The approved product has an estimated market size of around US$ 606 million for the twelve months ending June 2022, according to IQVIA.


Unichem receives ANDA approval for quetiapine extended-release tablets
Drug Approval | August 16, 2022

Unichem receives ANDA approval for quetiapine extended-release tablets

Quetiapine Extended-Release Tablets are indicated for the treatment of Schizophrenia, Bipolar disorder and adjunctive treatment of Major Depressive Disorder (MDD)


Fish & Richardson secures win for Exela Pharma Sciences in ELCYS patent infringement litigation
News | August 16, 2022

Fish & Richardson secures win for Exela Pharma Sciences in ELCYS patent infringement litigation

ELCYS is the only FDA-approved cysteine hydrochloride injection on the market for use as an additive to amino acid solutions


Arbitrator rules in favor of Daiichi Sankyo in dispute with Seagen
News | August 15, 2022

Arbitrator rules in favor of Daiichi Sankyo in dispute with Seagen

All claims made by Seagen regarding Daiichi Sankyo antibody drug conjugates are denied