Lupin gets FDA nod for 2 generics
Lupin has received the Food and Drug Administration’s blessing for clomipramine hydrochloride capsules in 25-, 50- and 75-mg dosage strengths. The product is a generic version of SpecGx’ s Anafranil capsules.
It is indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder
Anafranil capsules, 25 mg, 50 mg, and 75 mg had a market value of approximately $109.6 million, according to IQVIA September 2018 data.
The FDA also approved Lupin’s potassium chloride for oral solution, 20 mEq.
The product, which is a generic version of Pharma Research Software Solution’s potassium chloride for oral solution, 20 mEq, 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.
The product had a market value of approximately $105 million, according to September 2018 IQVIA data.
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