The FDA set a target action date of April 28, 2026, under the Prescription Drug User Fee Act
The audit has been concluded with no major observations
Loteprednol Etabonate Ophthalmic Gel, 0.38% is a corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery
Granules India receives 1 observation from USFDA for Chantilly facility
Doxorubicin Hydrochloride Liposome Injection is indicated for the treatment of Ovarian Cancer, AIDS-Related Kaposi's Sarcoma, and Multiple Myeloma
The approval in China is supported by a robust local clinical development program confirming the drug’s safety, tolerability, and efficacy profile
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
Label updates reflect growing body of real-world evidence and regulatory confidence in the safety profile of the class of CD19- and BCMA-directed autologous CAR T cell therapies, reinforcing efforts to increase equitable access
The approval is based on a comprehensive package of analytical, nonclinical, and clinical data
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
Bonthapally facility is one of the world's largest single-site Paracetamol API manufacturing plants by volume
The company will provide the necessary response to USFDA within stipulated 15 days
The company received seven observations in the Form-483
Sun Pharma gets 8 observations from USFDA for Halol facility
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