Eagle’s Pemfexy (pemetrexed for injection) Receives Final FDA’s Approval to Treat Nonsquamous Non-Small Cell Lung Cancer

Shots:

• The US FDA has approved Eagle’s Pemfexy, a branded alternative to Alimta and is expected to be available in the market from Feb 01, 2022 with a subsequent uncapped entry on Apr 01, 2022.
• The Pemfexy has received its tentative approval in 2017, indicating that therapy met all its quality, safety and efficacy standards, but at the time was not eligible for marketing in the US because of existing patent protections
• The final approval follows the settlement agreement signed b/w Eagle and Eli Lilly on Dec 13, 2019, providing a release from all claims by the parties. Following the final approval, Eagle has exclusive rights to commercialize Pemfexy (ready to dilute formulation) for 4mos. beginning Feb 01, 2022

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