Lupin Limited, a pharmaceutical company, has received tentative approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application for Amifampridine Tablets, 10mg. This product is indicated for the treatment of Lambert-Eaton myasthenic syndrome in adults and pediatric patients 6 years of age and older. The drug is a generic version of Firdapse Tablets, 10mg, which has an estimated global net sale of $306 million for the fiscal year ended December 31, 2024.
The product will be manufactured at Lupin’s Goa facility in India, making it a significant milestone for the company. The tentative approval is a crucial step towards making the drug available to patients at an affordable price, as it allows the company to market and sell the product in the US market. The drug is expected to be a major contributor to the company’s revenue, given its high estimated global net sales.
Lambert-Eaton myasthenic syndrome is a rare autoimmune disorder that affects the nervous system and can cause muscle weakness and paralysis. The condition can significantly impact daily life, making it essential to have effective treatment options available. With this approval, Lupin’s Amifampridine Tablets, 10mg, is set to provide a cost-effective alternative to existing treatment options, thereby improving patient access to the medication.
The approval is a testament to Lupin’s commitment to providing high-quality and affordable generic medicines to patients worldwide. The company’s Goa facility has a reputation for producing high-quality products, and this approval is a reflection of the facility’s capabilities. Overall, this approval is a significant achievement for Lupin, and the company is expected to benefit significantly from the sale of this product in the US market.