Drug Approval | October 15, 2024
Lyka’s patent pending Drug Pregabalin Gel 8% w/w receives approval from CDSCO
Lyka has received the CDSCO approval for manufacturing and marketing of Pregabalin Gel 8% w/w
Lyka has received the CDSCO approval for manufacturing and marketing of Pregabalin Gel 8% w/w
Under the licensing agreement, Alkem will carry out the clinical development of “SON-080” in India with support from Sonnet and enable global and India regulatory filings
Gross profit was Rs. 328.8 crore, up by 27.8% YoY with a gross margin expansion of 418 bps to 55.7%
The EIR was issued post the last inspection of the facility conducted from May 6-10, 2024 which concluded with zero FDA 483 observations
The successful completion of the global Phase 3 trials paves the way to obtain marketing approval in the U.S. and EU
SMS Pharmaceuticals has reported total income of Rs. 165.81 crores during the quarter ended June 30, 2024
The approved product has an estimated market size of US$ 268 million for the twelve months ending June 2024, according to IQVIA
Approval is based on data from two Phase III studies in branch and central retinal vein occlusion (RVO) showing early and sustained vision improvements non-inferior to aflibercept
Acquisition strengthens and diversifies Merck’s pipeline with the addition of Restoret
Vabysmo PFS is the first and only syringe prefilled with an FDA-approved bispecific antibody to treat retinal conditions that can cause blindness
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