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Latest From Renaissance Acquisition Holdings LLC
Advair Generic: Mylan Takes Issue With US FDA's 'Major' Concerns
Dispute over analysis of inhaler device could delay launch of competitor to GSK's franchise until 2018; FDA's complete response letter to Mylan' deemed 'major.'
Advair Generic: Mylan Takes Issue With US FDA's 'Major' Concerns
Dispute over analysis of inhaler device could delay launch of competitor to GSK's franchise until 2018; FDA's complete response letter to Mylan' deemed 'major.'
Mylan Takes Issue With FDA Over 'Major' CRL For Advair Generic
FDA's complete response letter to Mylan's ANDA for a generic version of Advair was deemed a "major" CRL, likely delaying a launch into 2018.
Mylan Takes Issue With FDA Over 'Major' CRL For Advair Generic
FDA's complete response letter to Mylan's ANDA for a generic version of Advair was deemed a "major" CRL, likely delaying a launch into 2018.
Company Information
- Industry
- Contract Research, Toxicology Testing-CRO
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Pharmaceuticals
- Generic Drugs
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