Drug Approval | May 08, 2025
Lupin launches Eslicarbazepine Acetate tablets in US
Lupin is one of the first ANDA applicants and is eligible for 180 days of shared generic exclusivity
Lupin is one of the first ANDA applicants and is eligible for 180 days of shared generic exclusivity
This outcome reflects Innoxel Lifesciences' ongoing commitment to maintaining the highest standards of quality, compliance, and regulatory excellence
Tolvaptan is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease
Amifampridine Tablets, 10 mg are indicated for the treatment of Lambert-Eaton myasthenic syndrome in adults and pediatric patients 6 years of age and older.
The study demonstrated equivalent efficacy, safety, immunogenicity, and pharmacokinetics between YESINTEK and the reference product Stelara
the inspection conducted from January 27 to January 31, 2025
Revenue up 11% to Rs 5,768 crore as compared to Rs 5,197 crore
The inspection was carried out from January 28 to February 1, 2025
Recommendation based on results of Phase 3 CheckMate -9DW clinical trial demonstrating statistically significant and clinically meaningful improvement in overall survival with Opdivo plus Yervoy compared to investigator’s choice of lenvatinib or sorafenib in this patient population
BRAFTOVI combination regimen is the first and only targeted therapy approvedby the U.S. FDA for treatment-naïve patients with metastatic colorectal cancer with a BRAF V600E mutation
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