Lupin gets USFDA nod for Cinacalcet tablets and intraocular solution

Drug firm Lupin Wednesday said it has received approval from the US health regulator for its generic Cinacalcet tablets used for treatment of excess parathyroid hormone.

The company has received approval from the United States Food and Drug Administration (USFDA) for its Cinacalcet tablets in the strengths of 30 mg, 60 mg, and 90 mg, Lupin said in a filing to BSE.

The tablets are generic version of Amgen Inc's Sensipar tablets in the same strengths, it added.

As per IQVIA MAT March 2019 data, Cinacalcet tablets, 30 mg, 60 mg, and 90 mg, had annual sales of around USD 1,527 million in the US, Lupin said.

The tablets are indicated for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease on dialysis and in hypercalcemia in adult patients with parathyroid carcinoma, it added.

In a separate filing Lupin said it has received approval for its Phenylephrine and Ketorolac intraocular solution, 1 per cent/0.3 per cent.

The company's product is a generic version of Omeros Corporation's Omidria intraocular solution in the same strength, it added.

As per IQVIA MAT March 2019 data, Phenylephrine and Ketorolac intraocular solution, 1 per cent/0.3 per cent, had annual sales of around USD 42.8 million in the US, Lupin said.

The product is indicated for maintaining pupil size by preventing intraoperative miosis and for reducing postoperative ocular pain, it added.

Shares of Lupin were trading at Rs 752.60 per scrip on BSE, down 1.08 per cent from the previous close.