Eugia Pharma Receives USFDA Approval for Esmolol HCl in Sodium Chloride Injection 2,500 mg/‌250 mL and 2,000 mg/‌100 mL Single-Dose Containers (Bags)

Eugia Pharma Limited is pleased to announce that the company has received a first-cycle approval from the US Food & Drug Administration (USFDA) to manufacture and market Esmolol HCl in Sodium Chloride Injection 2,500 mg/‌250 mL and 2,000 mg/‌100 mL Single-Dose Containers (Bags).

Indications for this product include:

• Rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postopera­tive, or other emergent circumstances. Noncompen­satory sinus tachycardia where the rapid heart rate requires specific intervention. Intended for short-term use.
• Short-term treatment of tachycardia and hyper­tension that occur during induction and tracheal intubation, surgery, on emergence from anesthesia and in the postoperative period.

Refer to package insert for full prescribing information.