The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) and is used in the treatment of seizures.
This approval showcases Teva’s proven strengths in complex generic formulations development and device engineering
The product will be manufactured at Lupin’s Nagpur facility in India
Approval based on results from the Phase 3 KEYNOTE-859 trial, which demonstrated significant improvement in overall survival in these patients versus chemotherapy alone
XTANDI becomes the first and only androgen receptor signaling inhibitor approved for use with or without a GnRH analog therapy in nonmetastatic castration-sensitive prostate cancer
The countrywide initiative aims to spread awareness, educate the public & ensure that no one is left behind in the fight against respiratory diseases
Approval based on results from TOPAZ-1 global Phase III trial and a Chinese patient
Likmez oral suspension is the first and only FDA-approved liquid option for patients with adherence hurdles such as dysphagia, difficulty swallowing
Phase 3 data expected in the second half of 2024
Yesafili, received marketing authorization approval from the European Commission for the European Union
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