NATCO Pharma introduced submission of Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the United States Food and Drug Administration (FDA) for the conventional version of Olaparib Tablets 100mg and 150mg.
Olaparib is indicated usually for certain styles of ovarian, breast, pancreatic and prostrate most cancers. Olaparib Tablets are advertised within the United States (US) by way of AstraZeneca below logo Lynparza. NATCO has been named as defendant in a lawsuit filed within the US district court docket of New Jersey by AstraZeneca and Kudos Pharmaceuticals.
NATCO and its co-development and advertising accomplice Alembic Pharmaceuticals believe that the ANDA is likely sole first-to-record based totally on its submitting date and may be eligible for 180 days of advertising exclusivity on the time of release of the product.
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