The FDA has determined that the known and potential benefits of the vaccine for the prevention of Covid-19 outweigh the known and potential risks for individuals 18 years of age and older for whom other authorized or approved vaccines are not accessible
While Pregabalin will be manufactured at the Aurangabad facility, Iloperidone will be manufactured at the Goa facility
The drug will be manufactured at the group's formulation facility at SEZ, Ahmedabad
According to the National Institutes of Health, more than six million Americans, most age 65 or older, may have dementia caused by Alzheimer's disease, a brain disorder known to slowly destroy memory and thinking skills
The approved product has a market size of US $ 1172 million for the twelve months ending March 2022, according to IQVIA
Docosanol Cream, 10% (OTC) has an estimated market size of US$60 million for twelve months ending December 2021 according to IQVIA
The inspection was triggered by Shilpa's submission of applications for four ANDA's to seek approval to use this site as an alternate testing laboratory
The USFDA approval in AS marks the fifth indication for Rinvoq in chronic immune-mediated diseases
The planned Phase 1 study is a double-blind, randomized, placebo-controlled dose-escalation study in healthy adult subjects and AD patients
Approval based on groundbreaking Phase 3 EXPLORER-HCM trial demonstrating benefit in patients receiving Camzyos versus placebo
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