Natco
Lupin and Natco gain U.S. FDA approval for their generic bosentan suspension
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Lupin and Natco Pharmaceuticals have announced that their jointly developed generic version of bosentan suspension, used to treat pulmonary arterial hypertension (PAH), has received approval from the US Food and Drug Administration (FDA). This approval makes the companies’ product the first FDA-approved generic alternative to Pfizer’s branded treatment, Tracleer.
The bosentan suspension is indicated for the treatment of PAH, a rare and chronic respiratory condition characterized by abnormally high blood pressure in the pulmonary arteries. The medication is used to delay disease progression and improve exercise capacity in patients with PAH.
Lupin and Natco’s generic version of bosentan suspension has been demonstrated to be therapeutically equivalent to Tracleer, which means it has the same efficacy, safety, and dosage regimen as the branded product. The approval is based on a comprehensive regulatory submission package, which included results from clinical trials that evaluated the safety and efficacy of the generic product in comparison to Tracleer.
“This FDA approval marks a significant milestone for us and further reinforces our commitment to delivering high-quality generic products that make a meaningful difference in patients’ lives,” said Vinita Gupta, Managing Director, Lupin.
The approval is a significant win for Lupin and Natco, as it opens up the PAH market to more affordable treatment options. PAH is a rare condition that affects an estimated 150,000 people in the US, and there is a high demand for treatments that can slow down disease progression.
The availability of a generic bosentan suspension is expected to benefit patients by providing a more affordable alternative to the branded treatment. This will not only increase patient access to treatment but also reduce the financial burden on healthcare systems.
The companies are set to launch their generic product in the US market shortly, making it the first FDA-approved generic alternative to Tracleer. With this approval, Lupin and Natco have demonstrated their capabilities to develop and launch high-quality generic products that can effectively compete with branded treatments in the US market.
Miralus, a collaboration between Lupin and Natco, receives US FDA approval for its generic Bosentan tablets for oral suspension, expanding access to vital hypertensive treatment options.
Natco Pharma, in alliance with Lupin, has received approval from the US FDA for its Abbreviated New Drug Application (ANDA) for Bosentan Tablets for Oral Suspension, 32 mg, a generic equivalent of Actelion Pharmaceuticals’ Tracleer Tablets for Oral Suspension. With this approval, Natco becomes the first company to file for the product in the US, granting it 180 days of marketing exclusivity. The generic drug is used to treat pediatric patients with idiopathic or congenital pulmonary arterial hypertension (PAH), helping to improve pulmonary vascular resistance and exercise ability. The estimated annual sales of Tracleer, the reference listed drug, are USD 11 million in the US, based on IQVIA MAT data from December 2024.
Bosentan Tablets for Oral Suspension, 32 mg, is specifically indicated for children aged three and above with idiopathic or congenital PAH. The medication aims to lower pulmonary vascular resistance, which improves exercise ability and quality of life for patients affected by this rare and debilitating disease. With the approval of this generic equivalent, Natco Pharma will be the sole supplier of the product for the next six months, gaining a competitive edge in the US market.
Natco’s ANDA approval underscores the company’s commitment to offering high-quality generic alternatives to brand-name drugs. The company has successfully navigated the FDA approval process, ensuring that its generic product meets stringent standards for quality, safety, and efficacy. The approval is expected to make Bosentan Tablets for Oral Suspension, 32 mg, more accessible and affordable for pediatric patients with PAH, leading to improved patient outcomes and increased access to vital medication.
India’s Natco Pharma secures approval for generic version of Everolimus tablets.
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Natco Pharma, a leading Indian pharma company, has received the approval from the United States FDA (Food and Drug Administration) for its generic version of Everolimus tablets. Everolimus is a medication used to treat various cancers, including renal cell carcinoma and breast cancer. The generic tablets will be sold under the brand name “Natco Everolimus” and will be manufactured at Natco’s facility in Hyderabad, India.
The US FDA approval marks a significant milestone for Natco Pharma, which has been a pioneer in producing affordable and quality generic medicines for the global market. The company has a proven track record of developing and launching complex generics, including oncology products.
Natco Everolimus tablets will be available in 0.5 mg, 1.0 mg, and 2.5 mg strengths, making it a competitive alternative to the branded version of Everolimus, which is marketed by Novartis as Afinitor. The approved product will be available in a 28-day blister pack.
The approval was granted after the company completed rigorous testing and submission of data, including bioequivalence studies and clinical trials, to demonstrate that its generic version is equivalent to the branded version in terms of quality, purity, and performance.
Natco Pharma’s generics are known for their high-quality and affordability, making them an attractive option for patients and healthcare providers. The company’s portfolio includes a wide range of oncology products, including generic versions of other major cancer medications.
The approval of Natco Everolimus tablets is expected to benefit patients worldwide, particularly those in developing countries where access to affordable and effective cancer treatments is limited. With this approval, Natco Pharma has further strengthened its position as a leading global player in the generics market.