Drug Approval | 20 November 2023
Teva announces approval of a generic version of Forteo in US
This approval showcases Teva’s proven strengths in complex generic formulations development and device engineering
This approval showcases Teva’s proven strengths in complex generic formulations development and device engineering
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
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
Rocuronium Bromide Injection had estimated annual sales of USD 54 million in the US (IQVIA MAT August 2023).
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
Approval based on DESTINY-Lung02 results where AstraZeneca and Daiichi Sankyo’s Enhertu demonstrated a confirmed objective response rate of 49% and median duration of response of 16.8 months in previously treated patients
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
CB03 is a candidate drug for the treatment of ALS and other central nerve system (CNS) diseases
The vaccine further advances Pfizer’s vaccine portfolio and builds on more than 20 years of expertise and knowledge in the prevention of meningococcal disease
Short-term treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD)
Approval of oral, once-daily VELSIPITY based on favorable safety and efficacy data from the ELEVATE UC Phase 3 trials
This inspection is the fourth major regulatory inspection (after Russia, Canada and Brazil), cleared by this site in the past two years
Glenmark's current portfolio consists of 188 products authorized for distribution in the US
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