ROSEMONT, IL — Long Grove Pharmaceuticals, LLC, a supplier of differentiated pharmaceuticals, received Food and Drug Administration (FDA) approval for a generic Eribulin Mesylate Injection. Long Grove’s Eribulin Mesylate is an AP-rated chemotherapy medication bioequivalent to HALAVEN®.
“Our goal is to create more affordable pathways to pharmaceuticals. The introduction of a generic in a market where choices are limited is an important step to ensure patient access,” said Peter Karas, Chief Commercial Officer of Long Grove Pharmaceuticals. “We’re grateful for the opportunity to ensure that more patients benefit from this cancer treatment.”
Eribulin Mesylate Injection is a cancer medication that disrupts the growth of cancer cells. It was originally approved by the FDA in November 2010 to treat adult patients with locally advanced or metastatic breast cancer whose treatment has not progressed well through other cancer medicines. The FDA expanded its approval in January 2016 to adult patients who have already received anthracycline-containing therapy for advanced or metastatic liposarcoma.
Long Grove Pharmaceuticals received FDA approval for the drug through an Abbreviated New Drug Application (ANDA). The company’s Eribulin Mesylate Injection comes in a single dose vial with a rubber stopper not made with latex. The drug is manufactured in the European Union and is Trade Agreement Act (TAA) compliant.
