Branded Advair Breathes Another Day; Mylan Says A CRL Is On The Way For A Generic
FDA alerted Mylan to expect a complete response letter related to its ANDA for generic Advair. The company said it still could receive an approval prior to the standard 90-day time period after responding to the letter, because the application has a priority designation.
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Fulphila (pegfilgrastim-jmbd) to launch in US soon; Mylan overcomes complete response letter and gets approval without advisory committee review.
A biosimilar of Amgen's Neulasta appears on track for FDA approval by the June 4 action date, management said during an investor briefing that showcased Mylan's expansive biosimilar pipeline. Mid- to late-stage copies of products like Advair, Symbicort, Herceptin, Humira, Avastin, Rituxan, Eylea and Botox highlight the strategic direction Mylan moved in nearly a decade ago.
Novartis' generic drug unit confirmed the receipt of a complete response letter from the US FDA for a generic version of GlaxoSmithKline's Advair, following similar CRLs for Mylan and Hikma.