Natco Pharma gets final approval for Bosentan tablets for oral suspension
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-02-10 06:00 GMT | Update On 2025-02-10 06:00 GMT
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Hyderabad: NATCO Pharma Limited has announced final approval of its Abbreviated New Drug Application (ANDA) for Bosentan tablets for oral suspension (TFOS), 32mg, a generic version of Tracleer by Actelion Pharmaceuticals US Inc.
NATCO’s marketing partner for the ANDA, Lupin Pharmaceuticals, Inc. will market the product in the U.S.
"NATCO believes it has sole First-to-File status for the product and is eligible for a 180-day exclusivity at the time of launch. Launch details are bound by confidentiality," the Compay stated.
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