Lupin gets USFDA nod for antidepressant drug
NEW DELHI: Drug firm Lupin Monday said it has received approvals from the US health regulator for its Clomipramine Hydrochloride capsules, and Potassium Chloride for oral solution.
The company has received approval from the United States Food and Drug Administration (USFDA) to market its generic Clomipramine Hydrochloride capsules USP in the strengths of 25 mg, 50 mg, and 75 mg, Lupin said in a filing to BSE.
The product is a generic version of SpecGx LLC's Anafranil capsules in the same strengths, it added.
The capsules are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD), Lupin said.
As per IQVIA MAT September 2018 data, Anafranil capsules in the same strengths had annual sales of around USD 109.6 million in the US, it added.
In a separate filing, Lupin said it has received approval from the USFDA to market its Potassium Chloride for oral solution USP, 20 mEq.
The company's product is the generic version of Pharma Research Software Solution LLC's Potassium Chloride for oral solution, 20 mEq, it added. The product had annual sales of around USD 105 million in the US, Lupin said.
It "is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient," it added.