FDA 2017 First Generics Approvals Retain India Imprint
Indian companies continued to have marked presence in list of first generics approved by US FDA in 2017; clearances include some limited competition drugs and complex products that are vital for Indian firms as they transition their portfolios away from 'plain vanilla' generics.
You may also be interested in...
Sun Pharma has scooped a first ANDA approval for a rival to Takeda’s mesalamine-containing brand Pentasa, with Viatris making clear recently that it was eyeing a first-time generic launch for the gastrointestinal drug.
FDA approves the product well before Mylan's prediction of 2018.
By conducting a product development or pre-submission meeting, sponsors can receive a mid-review cycle meeting for a complex product ANDA.