Drug Approval | March 22, 2023
Granules Consumer Health concludes FDA audit with zero observations
The audit is a pre-approval inspection for three products filed from the facility
The audit is a pre-approval inspection for three products filed from the facility
Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, (RLD Rexulti) had estimated annual sales of US $1,575 million in the US (IQVIA MAT December 2022)
ZYIL1 is a novel oral small molecule NLRP3 inhibitor which has demonstrated CSF penetration in non-human primates
According to IQVIA sales data for the 12-month period ending January 2023, the Compazine Tablets, 5 mg and 10 mg market achieved annual sales of approximately US $26.9 million
Rocuronium Bromide Injection had an annual sale of approximately US $53 million in the US (IQVIA MAT December 2022)
The Indian government will float a global tender in April 2023 to procure HPV vaccines.
The antiviral is efficacious in non-human primates, and is safe and well-tolerated in humans
The Phase 3 data presented at AAD include a comprehensive review of the THRIVE-AA2 results and further elaborate the topline data reported in August 2022
The one-year-long study was aimed to evaluate the efficacy of LDH's digital therapeutics platform
This loan is in addition to earlier announced CAD 25 million loan committed by the Province of Quebec
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