 "Lupin Pharma")
Pharma major Lupin has received United States Food and Drug Administration (USFDA) approval for its new drug application for Varenicline Tablets, 0.5 mg and 1 mg. The company has received approval to market a generic equivalent of Chantix Tablets, 0.5 mg and 1 mg, of PF Prism CV. The product will be manufactured at Lupin's Pithampur facility in India, the company said in a regulatory filing with the BSE on December 6, 2023.
Notably, Varenicline Tablets, 0.5 and 1 mg are used as an aid to treat the habit of smoking. The total sales of Varenicline Tablets stood at $430 million in the US market.
Last month, Lupin announced the launch of Vilfuro-G, the world's first fixed-dose triple combination drug (FDC) for the treatment of chronic obstructive pulmonary disease (COPD) in India. This drug is available in a single-strength fixed dose, with a recommended once-daily dosage for the treatment of COPD, which refers to a group of diseases that cause airflow blockage and breathing-related problems. The development comes after the approval granted by the Drug Controller General of India for Lupin's Dry Powder Inhaler (DPI) product.
Earlier in November, Lupin partnered with pharmaceutical manufacturer Amman Pharmaceuticals Industries (Amman Pharma) for exclusive marketing and commercialisation of Ranibizumab, a biosimilar of Lucentis, in the West Asian region.
In a press release, Lupin stated, "Ranibizumab is a recombinant humanised IgG1 monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A (VEGF-A). Its indications encompass the treatment of patients with neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR) and myopic choroidal neovascularisation (mCNV)."
