Loteprednol Etabonate Ophthalmic Gel, 0.38% is a corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery
Eylea 8 mg is the first and only anti-vascular endothelial growth factor (VEGF) treatment in the EU with treatment intervals of up to 6 months for both patients with nAMD and DME
The inspection concluded with zero Form 483 observations
Prucalopride Tablets are bioequivalent to Motegrity Tablets, 1 mg and 2 mg, of Takeda Pharmaceuticals USA
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
WINREVAIR significantly reduced the risk of clinical worsening events in recently diagnosed PAH patients over 70 percent of whom were on double background therapy
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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