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Drugmaker Lupin on Monday said it has received the final approval from the U.S. Food and Drug Administration (U.S. FDA) for its abbreviated new drug application for Pitolisant Tablets, 4.45 mg and 17.8 mg. The U.S. FDA has approved the company’s generic as bioequivalent to Harmony Biosciences’ Wakix for the indications in the approved labeling….
Lupin, India’s No. 2 drugmaker, spins-out two oncology programmes to Kaveri | Photo Credit: Reuters Global pharma major Lupin has spun-out two oncology programmes to Kaveri Therapeutics Inc for $1..6 million, taking its stake in the U.S. clinical-stage oncology company to 82.2%. Its wholly-owned US subsidiary Lupin Inc (LI), which has entered into a licensing…
Read More “Lupin takes 82.2% stake in Kaveri Therapeutics, licences 2 oncology assets for $1.6mn” »
The U.S. Food and Drug Administration has approved Natco Pharma’s abbreviated new drug application (ANDA) for cancer drug Eribulin Mesylate Injection. File | Photo Credit: Getty Images The U.S. Food and Drug Administration (U.S FDA) has approved Natco Pharma’s abbreviated new drug application (ANDA) for cancer drug Eribulin Mesylate Injection, 1 mg/2ml (0.5 mg/ml) single-dose…
Read More “Natco Pharma, Lupin alliance secures U.S. FDA nod for generic breast cancer drug” »
Generic drugmaker Lupin has received tentative approval from the U.S. Food and Drug Administration for its abbreviated new drug application for Bictegravir, Emtricitabine and Tenofovir Alafenamide Tablets, 50 mg/200 mg/25 mg. The tablets are bioequivalent to Gilead Sciences Biktarvy Tablets, 50 mg/200 mg/25 mg and indicated for treatment of human immunodeficiency virus infection in…
Read More “U.S. FDA nod for Lupin’s copy of Gilead Sciences’ HIV drug ” »
Generic drugmaker Lupin has received U.S. Food and Drug Administration approval for its abbreviated new drug applications for Liraglutide Injection single-patient-use prefilled pens and Glucagon for injection vials. Both the products will be manufactured at the company’s injectable facility in Nagpur, Lupin said. Liraglutide injection 18 mg/3 mL (6 mg/mL) single-patient-use prefilled pen…
Read More “Lupin gets U.S. FDA nod for two generic diabetes drugs ” »