Lupin receives FDA approval for Clomipramine HCl Capsules

Pharma major Lupin has announced that it has received approval for its Clomipramine Hydrochloride Capsules USP, 25 mg, 50 mg, and 75 mg from the USFDA. The drug is a generic version of SpecGx LLC’s Anafranil capsules, and indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD).

Anafranil capsules had annual sales of approximately US$109.6-mn in the US.

…. And for KCl for Oral Solution

Lupin has also announced that it has received approval for its Potassium Chloride for Oral Solution USP, 20 mEq from the US FDA to market a generic version of Pharma Research Software Solution LLC’s Potassium Chloride for Oral Solution, 20 mEq.

The drug 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 had annual sales of approximately US$105-mn in the US.

Launches generic Nystatin and Triamcinolone Acetonide Cream

In another development, Lupin has announced the launch of Nystatin and Triamcinolone Acetonide Cream USP 100,000 units/gm; 0.1 %, having received an approval from the USFDA earlier.

The drug is the generic equivalent of Taro Pharmaceuticals’ Nystatin and Triamcinolone Acetonide Cream, and is indicated for the treatment of cutaneous candidiasis. It had annual sales of $54.3-mn in the US.