NATCO receives approval for Ibrutinib tablets from ANDA
The approval is for Ibrutinib tablets 560 mg, 420 mg, 280 mg and 140 mg strengths
The approval is for Ibrutinib tablets 560 mg, 420 mg, 280 mg and 140 mg strengths
The government has taken all the effective measures to make healthcare affordable
The company will review FDA's response and decide on appropriate next steps soon.
Apremilast tablets are indicated for the treatment of adult patients with moderate to severe plaque psoriasis .
According to IQVIA sales data for the 12 month period ending December 2020, the Cleocin T Gel, 1% market achieved annual sales of approximately $73.8 million.
All pending litigation between Biocon Biologics, Regeneron, and Bayer will be dismissed
The inspection concluded with one minor observation in Form 483
Updated results from the EMBER-3 study showed that the drug -- Inluriyo (imlunestrant) -- as a standalone treatment cut the risk of progression or death by 38%
The positive CHMP opinion is supported by results from the Phase III QUASAR trial
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