Rezipres, an ephedrine HCL (hydrochloride) injectable manufactured by Eton Pharmaceuticals, has been approved by FDA to treat clinically significant hypotension ( low blood pressure) observed in anesthetic locations. Eton’s stock trading remains suspended.
“This innovative sulfite-free formulation has been successfully sold in Europe for years, and we are excited to make it available to U.S. patients shortly,” stated Sean Brynjelsen, CEO of the company.
The investigational medication is under the evaluation of the FDA with a deadline of June 18 specified under PDUFA (Prescription Drug User Fee Act).
Topiramate oral solution, which has a deadline of August 6 set under the Prescription Drug User Fee Act, has also been submitted to get marketing authorization.