Tag: USFDAApproval
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Natco Pharma Secures USFDA Approval for Bosentan Tablets for Oral Suspension (32mg): A Game-Changer in PAH Treatment
Natco Pharma has received USFDA approval for its generic Bosentan tablets for oral suspension (32mg), a key treatment for pediatric pulmonary arterial hypertension (PAH). With First-to-File status, Natco is poised to capture significant market share through a 180-day exclusivity period. This approval opens new opportunities for Natco and its partner Lupin Pharmaceuticals in the growing U.S. pediatric PAH market, addressing a critical need for easier-to-administer treatments.
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Lupin Gains USFDA Approval for Generic HIV Medication
Lupin has received tentative approval from the USFDA for its generic version of the HIV drug Triumeq PD, combining Abacavir, Dolutegravir, and Lamivudine. This approval paves the way for more affordable HIV treatment options, particularly in underserved regions, enhancing access to life-saving care.