Glenmark Pharmaceuticals has secured tentative approval from the US Food and Drug Administration (FDA) for Calcipotriene and Betamethasone Dipropionate Foam, 0.005%|0.064%. The product is the generic version of Enstilar Foam, 0.005%|0.064%, a psoriasis medication from Leo Pharma. For the 12-month period ending March 2022, the Enstilar Foam, 0.005%|0.064% market achieved annual sales of around $115.2 […]
Glenmark Pharmaceuticals and Canadian pharma company SaNOtize Research & Development Corp. have launched the latter’s Nitric Oxide Nasal Spray under the brand name FabiSpray in India for the treatment of adults with Covid-19, who have a high risk of disease progression Earlier, Glenmark Pharmaceuticals had secured manufacturing and marketing approval from the Drugs Controller General […]
Glenmark Pharmaceuticals said that it has bagged final approval from the US States Food and Drug Administration (FDA) for Metronidazole Vaginal Gel, 0.75%, which is the generic for MetroGel-Vaginal Gel, 0.75% owned by Bausch Health US. As per IQVIA sales data for the 12-month period ending November 2021, the MetroGelVaginal Gel, 0.75% market recorded annual […]
Glenmark Pharmaceuticals said that it has secured tentative approval from the US Food & Drug Administration (FDA) for Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Pre-Filled Syringe. The drug is the generic version of Lexiscan Injection, 0.4 mg/5 mL (0.08 mg/mL), of Astellas US. Lexiscan Injection, 0.4 mg/5 mL (0.08 mg/mL) had annual sales […]
Glenmark Pharmaceuticals said that it has secured marketing approval for Ryaltris, a fixed-dose combination nasal spray, in 13 countries across the European Union (EU) and the UK. Ryaltris (olopatadine 665 µg and mometasone furoate 25 µg) has approval for the symptomatic treatment of seasonal and perennial allergic rhinitis in adults and children, aged over 12. […]
Glenmark Pharmaceuticals, an Indian pharma company, said that it has secured final approval for Clindamycin Phosphate Foam, 1% from the US Food and Drug Administration (FDA). Clindamycin Phosphate Foam is the generic version of Evoclin Foam, 1%, of Mylan Pharmaceuticals. Evoclin Foam is indicated for the treatment of acne. As per IQVIA, Evoclin Foam, 1% […]
Glenmark Pharmaceuticals Ltd said that it has secured tentative approval from the US Food and Drug Administration (FDA) for Nintedanib Capsules, 100mg, and 150mg. Nintedanib Capsules is the generic version of Ofev Capsules (nintedanib), 100mg and 150mg, owned by Boehringer Ingelheim Pharmaceuticals. Ofev is approved to be used in patients with idiopathic pulmonary fibrosis (IPF), […]
Glenmark Pharmaceutical has announced the UK launch of Tiogiva, a bioequivalent version of Tiotropium Bromide dry powder inhaler (DPI), for the treatment of chronic obstructive pulmonary disease (COPD). Tiotropium Bromide DPI is a bioequivalent version of Boehringer Ingelheim’s Spiriva Handihaler. As per data from IQVIA, Tiotropium DPI’s market size was $450 million in the European […]
Glenmark Pharmaceuticals said that interim data from its post marketing surveillance (PMS) study on Favipiravir (FabiFlu) in India supports the Covid-19 drug’s safety and effectiveness in real world settings. Besides, no new safety signals or concerns were seen in the 503 Covid-19 patients who are part of the PMS study. The time taken for fever […]
Glenmark Pharmaceuticals has secured final approval from the US Food and Drug Administration (FDA) for Theophylline Extended-Release Tablets, 300 mg, and 450 mg. The Indian pharma company’s Theophylline Extended-Release Tablets are bioequivalent and therapeutically equivalent to the reference listed drug – Theophylline Extended-Release Tablets, 300 mg, and 450 mg, owned by Alembic Pharmaceuticals. Theophylline extended-release […]