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The company believes this matter is without merit, Natco Pharma said in a statement. Breckenridge is the abbreviated new drug application (ANDA) holder and distribution partner for the generic product in the US, it added. Natco Pharma shares were trading 3.13 per cent down at Rs 885.00 apiece on the BSE. ....
Alembic Pharmaceuticals on Monday said it has received approval from the US health regulator to market a generic drug to treat cancer, via an exchange filing.
The company has received approval from the US Food & Drug Administration (USFDA) for Fluorouracil Injection, the drug firm said in a statement.
The approved product is therapeutically equivalent to Spectrum Pharmaceuticals Inc's product. ....
Natco Pharma on Monday said it has submitted a new application with the US health regulator for marketing authorisation of the generic version of Olaparib tablets, used in treating certain forms of ovarian, breast, pancreatic and prostate cancers, via an exchange filing.
The company has submitted an Abbreviated New Drug Application (ANDA) containing a 'paragraph IV' ....
The company has received final approval from the US Food and Drug Administration (USFDA) to market Decitabine for Injection in the strength of 50 mg/vial single-dose vial. ....