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Lupin Ltd.’s shares were up by 2.07 per cent after the company secured tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Canagliflozin Tablets. The tablets, available in 100 mg and 300 mg, serve as a generic equivalent of Janssen Pharmaceuticals, Inc. ‘s Invokana Tablets.
The product, aimed at improving glycemic control in adults with type 2 diabetes mellitus, will be produced at Lupin’s Pithampur facility in India. Canagliflozin Tablets had an estimated annual U.S. sales of USD 561 million.
In another development, Lupin has received U.S. FDA approval for its Abbreviated New Drug Application for Bromfenac Ophthalmic Solution, 0.07 per cent, a generic equivalent of Bausch & Lomb Inc.’s Prolensa Ophthalmic Solution, 0.07 per cent. Lupin, the exclusive first-to-file for this product, is eligible for a 180-day exclusivity period.
The solution, indicated for postoperative inflammation treatment and ocular pain reduction after cataract surgery, will also be manufactured at Lupin’s Pithampur facility in India. Bromfenac Ophthalmic Solution had estimated annual U.S. sales of USD 185 million.
The shares were up by 2.07 per cent to Rs 1221.05 at 09.55 am on the BSE.
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