Latest From Apotex Inc.
Keeping Track: A Diverse Array Of Approvals, A CRL For Evolus' Botox Competitor, And Coherus Refiles Neulasta Biosimilar
Keeping Track: FDA Delays Elagolix, Mylan Eyes For Neulasta Biosimilar Approval, And Duvelisib Gets Priority Review
The latest drug development news and highlights from our US FDA Performance Tracker.
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.
Apotex’s plans to launch a nasal spray formulation that competes with Cipla-Meda’s Dymista has been blocked by the Federal Court of Australia, at least for now. Apotex has challenged the validity of certain claims of the patent pertaining to Dymista.
- Generic Drugs
- Therapeutic Areas
- North America
- Parent & Subsidiaries
- Apotex Inc.
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- Jeremy B Desai, PhD, Pres. & CEO
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150 Signet Dr.
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