The new powder formulation gives children and adults living with Rett syndrome greater flexibility and choice in dose volume and taste
Indoco received the Establishment Inspection Report from the USFDA for its API manufacturing facility
The inspection concluded with one minor observation in Form 483
The FDA aims to make a decision by April 8, 2026
This approval confirms the facility's compliance with FDA quality standards and regulatory requirements
The company will respond to the US FDA within the stipulated timelines
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb
GSK holds exclusive global rights (excluding mainland China, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to advance its development and commercialization
The approval of Augmentin XR, granted to USAntibiotics, directly supports the CNPV program’s goals
The U.S. oncology market is projected to soar from $81 billion in 2025 to $212 billion by 2034
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