Drug Approval | February 14, 2022
Zydus gets 180 days of shared exclusivity for Roflumilast tablets
The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad
The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad
Rimegepant is the first oral calcitonin gene-related peptide receptor antagonist to demonstrate positive results in a pivotal trial in the Asia Pacific
Immune responses were about two-to-three-fold higher in adolescents than in adults against all variants studied. Vaccine was well-tolerated with no safety signals identified
Adds five years of market exclusivity on approval
On track to complete the BLA submission in the first half of 2022
The Vasostrict brand market had U.S. sales of approximately US $ 878.5 million MAT for the most recent twelve months ending in December 2021 according to IQVIA Health
Arformoterol Tartrate had estimated annual sales of US $ 251 million in the U.S. (IQVIA MAT December 2021)
Nearly 1 million people are living with multiple sclerosis in the United States. Spasticity is a commonly reported symptom for MS, with an estimated prevalence of spasticity of 67%
Lupin has reported consolidated financial results for the period ended December 31, 2021
Restasis has been approved for use in the U.S. for nearly 20 years, but until today, there was no approved generic product of this drug
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