Drug Approval | July 24, 2025
Zydus receives tentative approval from USFDA for Ibrutinib tablets
Ibrutinib tablets will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad
Ibrutinib tablets will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad
Celecoxib is a nonsteroidal anti-inflammatory drug
Emcure Pharmaceuticals successfully completes USFDA PAI of Oncology facility
Loteprednol Etabonate Ophthalmic Gel, 0.38% is a corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery
The inspection concluded with zero Form 483 observations
J B Chemicals and Pharmaceuticals receives ANDA approval for Amitriptyline Hydrochloride Tablets from USFDA
Prucalopride Tablets are indicated for the treatment of chronic idiopathic constipation in adults
The company will provide the necessary response to USFDA within stipulated 15 days
The inspection concluded successfully, with the facility found to be in compliance with the required regulations
Oxcarbazepine ER Tablets (RLD Oxtellar XR) had estimated annual sales of US$ 206 million in the US (IQVIA MAT April 2025)
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