Drug Approval | November 20, 2023
Lupin receives approval from US FDA for Ganirelix Acetate Injection
The product will be manufactured at Lupin’s Nagpur facility in India
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
Likmez oral suspension is the first and only FDA-approved liquid option for patients with adherence hurdles such as dysphagia, difficulty swallowing
This product will be manufactured at Lupin’s Pithampur facility in India
This product will be manufactured at Lupin's Nagpur facility in India
NATCO's Pharmacovigilance Department was inspected from October 30, 2023 to November 1, 2023
The inspection of the facility conducted from August 7 to August 11, 2023
The sBLA is supported by a usability study which confirmed that individuals over 18 years of age could self-administer
The company is confident of addressing all the observations within the stipulated time
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