Hyderabad, Feb 10 (Maxim News) Global pharma major Lupin Limited (Lupin) and its alliance partner natco Pharma Limited (NATCO) have announced that they received the approval from the United States Food and Drug Administration (U.S.FDA) for Natco’s Abbreviated new Drug Application (AnDA) for Bosentan Tablets for Oral Suspension 32 mg.
The approval will enable the company to market a generic equivalent of Tracleer Tablets for Oral Suspension of Actelion Pharmaceuticals US, Inc.
The company press release said NATCO is the exclusive first-to-file for this product and is eligible for 180 days exclusivity. (Maxim News)
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