On Monday, Natco Pharma said that it had submitted an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (FDA) for approval of the generic version of Olaparib Tablets, which come in 100mg and 150mg strengths.
Olaparib is typically prescribed for specific types of breast, pancreatic, prostate, and ovarian cancer. AstraZeneca markets it in the US under the name Lynparza.
In a regulatory filing to the exchanges, the pharmaceutical company stated that it and its co-development and marketing partner Alembic Pharmaceuticals thought the ANDA might be the only first-to-file based on its filing date and might be qualified for 180 days of marketing exclusivity at the time of the product's launch. (ANI)
0 Comments