Aurobindo Pharma Limited has announced that the company has received US Food and Drug Administration (US FDA) final approval for fosinopril sodium and hydochlorothiazide tablets USP 10/12.5 mg and 20/12.5 mg.
Fosinopril sodium and hydochlorothiazide tablets USP 10/12.5 mg and 20/12.5 mg is generic equivalent to Monopril HCT tablets 10/12.5 mg and 20/12.5 mg of Bristol Myers Squibb. Fosinopril sodium and hydochlorothiazide tablets are indicated for hypertension and fall under the cardio vascular system (CVS) therapeutics segment. The product will be launched shortly, a company press release said.
Aurobindo now has a total of 96 ANDA approvals (69 final approvals and 27 tentative approvals) from US FDA.