Lupin Ltd 06 Dec 2023 12:00 AM
Lupin receives USFDA approval for Varenicline Tablets,
Lupin has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Varenicline Tablets, 0.5 mg and 1 mg, to market a generic equivalent of Chantix� Tablets, 0.5 mg and 1 mg, of PF Prism C.V. The product will be manufactured at Lupin`s Pithampur facility in India. Varenicline Tablets, 0.5 mg and 1 mg are indicated for use as an aid to smoking cessation treatment. Varenicline Tablets (RLD Chantix�) had estimated annual sales of USD 430 million in the U.S. (IQVIA MAT October 2023). Powered by Capital Market - Live News
Lupin Ltd 01 Dec 2023 12:00 AM
Lupin launches contraceptive drug Turqoz¿ Tablets in the US,
Lupin announced the launch of Turqoz� (Norgestrel and Ethinyl Estradiol) Tablets USP, 0.3 mg/0.03 mg, after having received an approval from the United States Food and Drug Administration (U.S. FDA). Turqoz� (Norgestrel and Ethinyl Estradiol) Tablets USP, 0.3 mg/0.03 mg is the generic equivalent of Lo/Ovral-28 (Norgestrel and Ethinyl Estradiol) Tablets, 0.3 mg/0.03 mg of Wyeth Pharmaceuticals LLC and is a contraceptive drug indicated to prevent pregnancy. Norgestrel and Ethinyl Estradiol Tablets USP (RLD: Lo/Ovral-28) had estimated annual sales of USD 33 million in the U.S. (IQVIA MAT October 2023). Powered by Capital Market - Live News
Lupin Ltd 24 Nov 2023 12:00 AM
Lupin allots 21,390 equity shares under ESOP,
Lupin has allotted 21,390 fully paid-up equity shares of Rs 2 each under ESOP. With this allotment, the paid up equity share capital has increased to Rs 91,05,76,916 consisting of 45,52,88,458 equity shares of Rs 2/- each.Powered by Capital Market - Live News
Lupin Ltd 23 Nov 2023 12:00 AM
Lupin receives USFDA approval for Bromfenac Ophthalmic Solution,
Lupin has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Bromfenac Ophthalmic Solution, 0.07%, to market a generic equivalent of Prolensa� Ophthalmic Solution, 0.07%, of Bausch & Lomb Inc. Lupin is the exclusive firstto-file for this product and is eligible for 180-day exclusivity. The product will be manufactured at Lupin`s Pithampur facility in India. Bromfenac Ophthalmic Solution, 0.07% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. Bromfenac Ophthalmic Solution (RLD Prolensa�) had estimated annual sales of USD 185 million in the U.S. (IQVIA MAT September 2023). Powered by Capital Market - Live News
Lupin Ltd 23 Nov 2023 12:00 AM
Lupin receives USFDA`s tentative approval for Canagliflozin Tablets,
Lupin has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Canagliflozin Tablets, 100 mg and 300 mg, to market a generic equivalent of Invokana� Tablets, 100 mg and 300 mg, of Janssen Pharmaceuticals, Inc. This product will be manufactured at Lupin`s Pithampur facility in India. Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated:  - as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus  - to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease  - to reduce the risk of end-stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria. Canagliflozin Tablets (RLD Invokana�) had estimated annual sales of USD 561 million in the U.S. (IQVIA MAT September 2023). Powered by Capital Market - Live News
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