Pharma major Lupin said it received final approval for to launch a generic version of Valeant Pharmaceuticals’ Xenazine in the US. Tetrabenazine Tablets, 12.5 mg and 25 mg, has annual sales of approximately USD 288.1 million in the US, according to IQVIA. The tablet is indicated for the treatment of chorea, or involuntary movements associated […]
India-based pharma major Lupin said the US drugs regulator has granted it a conditional, or tentative, approval to sell a generic version of the popular testosterone gel AndroGel. AndroGel, made by AbbVie Inc, is a big-selling drug with annual sales of well over $1 bln. AbbVie, which has patents valid up to 2020 on the […]
Pharma major Lupin said it launched a generic version of Bayer’s birth control drug Safyral tablets in the US. The company had received FDA approval for the launch in December. The tablets has annual sales of approximately USD 22 million in the US. Lupin’s product will be called Tydemy. The combination is indicated for use […]
Pharma major Lupin said it has launched a testosterone topical solution in the US for males suffering from the deficiency of the hormone. Lupin’s Testosterone Topical Solution is the generic equivalent of Eli Lilly and Company’s Axiron solution, Testosterone Topical Solution, 30 mg per actuation had annual sales of approximately $179 million in the US, […]
Pharma major Lupin said it has launched the generic version of Allergan’s Alzheimer’s drug Namenda XR in the US. The medicine has annual sales of approximately USD 936 million in the US, making it almost a billion-dollar drug. The launch was done in dosages of 7mg, 14mg, 21mg and 28mg of Memantine Hydrochloride. The drug […]
Pharma major Lupin said it has launched a generic version of Roche’s big-selling flu drug Tamiflu in the US. The drug, known as Oseltamivir Phosphate, had annual tablet sales of approximately USD 518 million in the US, making it one of the biggest generics in the market. The dosages that have been launched are 30 […]
Pharma major Lupin said it has launched a generic version of Concordia’s ADHD drug Kapway in the US. Kapvay tablets has annual sales of approximately USD 66 million in the US. It was in November last year that Lupin and Ajanta Pharma said they’d both got approval to launch Clonidine Hydrochloride tablets from the US […]
Pharma company Lupin said it has launched a generic version of Pfizer Inc.’s antibiotic Vibra-Tab. The drug has annual sales of around $144 million in the US, the Indian company said. The AB-rated generic was approved by the United States Food and Drug Administration (FDA) earlier. Doxycycline Hyclate Tablets 100 mg is indicated for the […]
Pharma Major Lupin announced that it has received final approval from the US Food & Drug Administration to market a generic version of Dovonex Scalp Solution from Leo Pharmaceutical Products Ltd. Calcipotriene Topical Solution is indicated for the topical treatment of chronic, moderately severe psoriasis of the scalp. Lupin’s Calcipotriene Topical Solution, 0.005% (Scalp Solution) […]
Pharma Major Lupin said it got the approval of the US Food and Drug Administration to launch a generic version of Bayer’s oral contraceptive Safyral. The branded version has annual sales of around $23 mln in the US. Lupin’s product will be called Tydemy. The combination is indicated for use by women to prevent pregnancy […]
Pharma major Lupin said it a warning letter from the US Food and Drug Administration for its formulations manufacturing facilities in Goa and Indore on Monday. “We are deeply disappointed to hove received this outcome. While there will be no disruption of existing product supplies from either of these locations, there will likely be a […]
Pharma major Lupin reported an 8% fall in Q2 revenue to Rs. 3,952 cr. Earnings before Interest, Tax, Depreciation and Amortization (EBITDA) for the quarter fell by 13% to 927 cr. Net profit was also down by 31.3% at Rs 455 cr in in the September quarter. The profit was higher than the mean analyst […]
Pharma Major Lupin said it received final approval from the United States Food and Drug Administration (FDA) to market a generic version of Concordia Pharmaceuticals Inc.’s ADHD drug Kapvay. It had annual sales of approximately USD 66 million in the US. Clonidine Hydrochloride, the AB rated generic equivalent, is used for the treatment of attention […]
Pharma major Lupin said that its US subsidiary, Lupin, Inc has acquired Symbiomix Therapeutics, LLC for a cash consideration of USD 150 million including a USD 50 million upfront and other time‐based payments. In addition, there are sales based contingent payments. Lupin had entered into an option to acquire the company earlier this year. Symbiomix […]
Pharma manufacturer Lupin said it received approval to launch the generic version of US World Meds’ Corgard heart drug. Nadolol Tablets USP, 20 mg, 40 mg, and 80 mg Tablets had annual sales of approximately USD 109.8 million in the US, the Indian drugmaker said. Lupin’s Nadolol Tablets are the AB rated generic equivalent of […]
Lupin said it received final approval to market a generic version of G.D. Searle LLC Flagyl antibiotic tablets in the US. Flagyl tablets had US sales of USD 44.1 million Lupin’s Metronidazole Tablets USP, 250 mg and 500 mg are the AB rated generic equivalent of the drug. It is indicated in the treatment of […]
Pharma company Lupin said it received final approval from the US Food and Drug Administration for launching a generic version of Pfizer Inc.’s acne drug Vibra-Tabs. Doxycycline Hyclate Tablet 100 mg had US sales of USD 149.9 million per year, the company said. Doxycycline Hyclate is the AB rated generic equivalent of Pfizer Inc.’s Vibra-Tabs. […]
Pharmaceuticals company Lupin said it received a 505 (b)(2) NDA approval for its Nikita”M (Pitavastatin) Tablets 1 mg, 2 mg and 4 mg from the United States Food and Drug Administration (FDA). A 505(b)(2) approval refers to one given by relying on studies already performed on a previously approved drug. The product is an alternate […]
Pharma company Lupin said it launched Moxifloxacin Hydrochloride eye solution in the US. Lupin’s Moxifloxacin Hydrochloride Ophthalmic solution USP, 0.5% (base), is an AT1 rated generic equivalent of Novartis Pharms Corp.’s Vigamox Ophthalmic solution. It is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the organisms. Vigamox Ophthalmic solution had US […]
Pharma Major Lupin said it launched Desoximetasone cream for treating skin problems in the US market. The company had received approvals from the US Food and Drug Administration earlier. The drug is the generic equivalent of Tarot Pharma’s Topicort, which had US sales of $38 million per year. The drug is used for relief of […]
