The company’s injectable product, esmolol hydrochloride in sodium chloride, will be offered in single-dose plastic bags, according to Mylan.
The FDA approved Mylan’s drug for the short-term treatment of control of ventricular rate in supraventricular tachycardia, including atrial fibrillation, atrial flutter, control of heart rate in non-compensatory sinus tachycardia and control of perioperative tachycardia and hypertension.
Esmolol hydrochloride in sodium chloride brought in $126 million in sales for the 12 months ending June 30, 2018, according to IQVIA.
In August, shares in Mylan fell after the pharmaceutical company missed expectations on Wall Street with its second-quarter financial results.
The Canonsburg, Penn.-based company posted profits of $37.5 million, or 7¢ per share, on sales of $2.8 billion for the three months ended June 30, representing a bottom-line loss of -87.4% on a sales loss of 5% compared with the same period last year.
Adjusted to exclude 1-time items, earnings per share were $1.07, behind consensus on The Street, where analysts were looking for sales of $2.96 billion.