Indian pharmaceutical major Lupin Ltd has achieved a significant milestone with the receipt of approval from the United States Food and Drug Administration (USFDA) for its new drug application involving Varenicline Tablets in 0.5 mg and 1 mg strengths. This approval allows Lupin to market a generic equivalent of Chantix Tablets, also available in 0.5 mg and 1 mg, originally produced by PF Prism CV. The manufacturing of this product will take place at Lupin’s Pithampur facility in India, according to a regulatory filing with the Bombay Stock Exchange (BSE) on December 6, 2023.
Varenicline Tablets, prescribed in 0.5 mg and 1 mg dosages, serve as an aid to combat smoking habits. The total sales of these tablets in the US market have amounted to $430 million, further highlighting the potential impact of Lupin’s generic equivalent.
This approval follows Lupin’s recent announcement of the world’s first fixed-dose triple combination drug (FDC) for treating chronic obstructive pulmonary disease (COPD) in India. Known as Vilfuro-G, this drug offers a single-strength fixed dose, recommended for once-daily usage in COPD treatment. The Drug Controller General of India granted approval for Lupin’s Dry Powder Inhaler (DPI) product, marking a significant advancement in respiratory care.
In another strategic move, Lupin partnered with Amman Pharmaceuticals Industries (Amman Pharma) in November for the exclusive marketing and commercialization of Ranibizumab. This biosimilar of Lucentis holds indications for the treatment of various eye conditions, including neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR), and myopic choroidal neovascularization (mCNV).
The recent USFDA approval for Varenicline Tablets reinforces Lupin’s commitment to delivering high-quality pharmaceuticals across a range of therapeutic areas. As the company continues to expand its product portfolio and strengthen its presence in key markets, Lupin remains at the forefront of innovation in the pharmaceutical industry.
