americanpharmaceuticalreviewDecember 30, 2019
Tag: Eton , Biorphen , Injection , Phenylephrine , Hypotension
Eton Pharmaceuticals announced Biorphen®, the first and only FDA-approved ready-to-use formulation of phenylephrine for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia, is now commercially available. Biorphen is available in a 5mL ampule containing 500mcg of phenylephrine. The product is now available for ordering through wholesalers McKesson, AmerisourceBergen, and Cardinal Health.
"Since Biorphen’s approval, we have seen strong interest from both physicians and hospital pharmacy directors and we are excited to begin supplying the product. The availability of Biorphen reduces the need for hospitals to rely on compounders to provide unapproved compounded phenylephrine," said Sean Brynjelsen, President and Chief Executive Officer of Eton. "In addition, Biorphen’s three-year shelf life allows hospitals to more easily stock the product in operating rooms, emergency rooms, and crash carts. We are well prepared for the commercial success of Biorphen with a strong and experienced sales team that is fully trained and deployed promoting Biorphen to hospitals throughout the US."
"The teams at Eton and Sintetica have worked closely together to ensure that Biorphen is ready for launch and to assuredly supply the United States healthcare system from day one with the first and only FDA-approved ready-to-use injectable formulation of phenylephrine," said Pasquale Mitidieri, Corporate Director of Sintetica’s Global Division.
Eton estimates the total addressable market for Biorphen is more than 20 million units annually. In tandem with its manufacturing partner Sintetica, Eton expects to have the capacity to supply this market as necessary. Eton’s sales force currently includes a team of field representatives and inside sales representatives that will be initially targeting the institutions with the highest phenylephrine usage.
Biorphen® (phenylephrine HCI) Injection is the first and only FDA-approved ready-to-use formulation of phenylephrine for treating clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. Ready-to-use Biorphen can be standardized and stocked in operating rooms, emergency departments and intensive care units, as well as in crash carts throughout the hospital. With a three-year shelf life, Biorphen can be stocked throughout hospitals without frequent restocking.
BIORPHEN injection is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.
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