Posted by Michael Wonder on 11 Feb 2020
Eagle Pharmaceuticals receives final FDA approval for Pemfexy (pemetrexed for injection)
10 February 2020 - Eagle has exclusive rights to commercialise product for four months beginning 1 February 2022.
Eagle Pharmaceuticals today announced that it has received final approval from the U.S. FDA for its novel product, Pemfexy (pemetrexed for injection), a branded alternative to Alimta.
The conversion from tentative to a final approval follows the Company’s settlement agreement reached with Eli Lilly and Company on 13 December 2019. This agreement provides for a release of all claims by the parties and allows for an initial entry of Pemfexy into the market (equivalent to approximately a three-week supply of current Alimta utilisation) on 1 February 2022, and a subsequent uncapped entry on 1 April 2022.
