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

Click here ­to­ read full press release/ article | Ref: Eagle | Image: Eagle