India-based Natco Pharma has filed an application with the US Food and Drug Administration seeking permission to market a generic copy of Lonsurf, a drug approved just four years ago to treat colorectal/gastric cancers. The application has been filed with a ‘Paragraph IV’ declaration. Such a declaration essentially states that the filer, Natco, believes that […]
Hyderabad-based pharmaceutical company Natco Pharmaceuticals said United States Food and Drug Administration (USFDA) issued nine observations after an inspection at Natco’s formulation facility in Kothur, Hyderabad. Natco said it believes that most of the observations were ‘procedural’ in nature and not pertaining to data integrity. Natco said that it will address the USFDA observation within […]
Pharmaceutical major Lupin and partner Natco Pharma received approval from the US Food and Drug Administration (FDA) to sell a generic equivalent of Novartis Pharmaceuticals’ Gleevec cancer tablets in the US market. Imatinib Mesylate Tablets, in 100 and 200 mg doses, have annual sales of around $655 million in the United States, Lupin said, making […]
NATCO Pharma Limited said it the US Food and Drug Administration approved the generic drug application filed by its marketing partner Mylan for injections used in the treatment of multiple sclerosis, a chronic inflammatory disease of the central nervous system. The drug, Glatiramer Acetate, will be manufactured by NATCO and sold by Mylan, and are […]
