Drug Approval | August 28, 2024
Zydus receives USFDA final approval for Amantadine ER capsules 68.5 mg
Also received tentative approval for 137 mg
Also received tentative approval for 137 mg
MoCRA mandates that all facilities involved in the manufacturing and processing of cosmetic products for sale in the United States
Brimonidine Tartrate Ophthalmic Solution, 0.025% (OTC) is indicated to relieve redness of the eye due to minor eye irritations.
Valbenazine Capsules had annual sales of US $1,993.6 mn in the United States (IQVIA MAT June 2024)
The inspection was concluded with zero observations
CN201 is a next generation CD3xCD19 bispecific antibody that augments and diversifies Merck’s pipeline, with potential applications in B-cell malignancies and autoimmune diseases
The EIR was issued post the last inspection of the facility conducted from May 6-10, 2024 which concluded with zero FDA 483 observations
Pharmaceuticals and Consumer Health report higher sales (Fx & portfolio adj.) and lower earnings
To co-develop and co-commercialize MK-6070, an investigational delta-like ligand 3 (DLL3) targeting T-cell engager, worldwide except for Japan where Merck retains exclusive rights
Being the first approved applicant, Lupin is eligible for 180 days of CGT exclusivity
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