Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (U.S. FDA) for Adapalene and Benzoyl Peroxide Gel, 0.1%|2.5%, the generic version of Epiduo® Gel of Galderma Laboratories L.P.
Glenmark Pharmaceuticals Inc USA (Glenmark), has been granted tentative approval by the United States Food & Drug Administration (FDA) for its lacosamide tablets, 50 mg, 100 mg, 150 mg and 200 mg, the generic version of Vimpat tablets, 50 mg, 100 mg, 150 mg and 200 mg of UCB Inc.
Glenmark Pharmaceuticals has entered into an agreement with Poland based Celon Pharma to develop and market a generic version of GlaxoSmithKline's Seretide Accuhaler in Europe used for treatment of lung diseases. The fluticasone/salmeterol dry powder inhaler is a combination product for the treatment of chronic obstructive pulmonary disease.
Glenmark Pharmaceuticals Inc., USA (Glenmark) has received final approval from the United States Food & Drug Administration (FDA) for voriconazole tablets, 50 mg and 200 mg of PF Prism C.V. (Prism).
Glenmark Pharmaceuticals S.A., GBR 830, a novel monoclonal antibody has completed clinical phase 1 dosing. GBR 830 is an antagonist of OX40, a costimulatory receptor expressed on T cells mediating T cell activation and survival. Glenmark has now completed clinical phase I studies for GBR 830 in the Netherlands.
In India Glenmark Pharmaceuticals has now introduced its new third generation oral anti diabetic agent Teneligliptin for type-2 diabetes at an affordable price of Rs. 19.90 per tablet. The first pan India launch of Teneligliptin under two brands: Ziten and Zita Plus took place in Bengaluru. The molecule gliptin comes under the category of DPP-4 inhibitors, which is backed by scientific data as being safe, well tolerated, weight neutral with low risk of hypoglycemia.
Glenmark Pharmaceuticals, has received approval from the US Food and Drug Administration (US FDA) for its cholesterol-lowering drug Ezetimibe. Ezetimibe is the generic version of Merck-Schering Plough's cholesterol-lowering drug with the product name Zetia.
Glenmark Pharmaceuticals Inc., USA (Glenmark) get final approval by the United States Food & Drug Administration (FDA) for calcipotriene cream, 0.005 per cent, the therapeutic equivalent of Dovonex cream, 0.005 per cent of Leo Pharma A/S. Glenmark strategy to start to shipping of calcipotriene cream, 0.005 per cent immediately.
Glenmark Pharmaceuticals granted tentative approval by the US health regulator to sell Rufinamide, which is used to treat seizures caused by Lennox-Gastaut syndrome.
Glenmark Pharmaceuticals Inc., USA (Glenmark) has received US FDA tentative ANDA approval for its rufinamide tablets USP, 200 mg and 400 mg.