Drug Approval | March 11, 2022
USFDA approves Lupin’s Vigabatrin oral solution
The product will be manufactured at Lupin’s facility in Goa, India
The product will be manufactured at Lupin’s facility in Goa, India
The company already has the world’s largest capacity for ibuprofen and is now looking at expansion in new molecules as the idea is to actually de-risk the business
The product will be manufactured at Lupin’s facility in Pithampur, India
Company expects strong organic growth in sales, EBITDA in 2022
Brazil has the 4th largest pet market in the world with an estimated market size of BRL 1.8 billion, growing annually at 16%
First of three Amneal biosimilars expected for U.S. approval and launch in 2022
If approved, Opdivo plus chemotherapy would be the first neoadjuvant immunotherapy-based option for patients with resectable non-small cell lung cancer in the U.S.
The NMPA Breakthrough Therapy Designation was based on results from the Phase 2 TRUST trial of ROS1 fusion-positive NSCLC patients treated with taletrectinib, a new generation of potent ROS1 inhibitors
Sevelamer Hydrochloride tablets, 800 mg is a generic equivalent of Renagel tablets, 800 mg
The sNDA was supported by the clinical results from cohort B of a single-arm, multi-center, pivotal study (RELIANCE study) on Carteyva in adult patients with relapsed or refractory B cell non-hodgkin lymphoma in China
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