In recent times, it has been observed that high number of generic drugs are being approved by the United States Food and Drug Administration (US FDA). In parallel, there are also instances of Refuse to Receive (RTR) from the health authority. It might be due to missing or misleading information provided in the Abbreviated New Drug Application (ANDA) Submissions.
October 30, 2018 Pharmaceutical
Do you know? The United States Food and Drugs Administration (US FDA) has yet again set a new record for the number of generic drug approvals. In comparison to FY 2017’s 937 approvals, FDA has approved a total of 971 generic drugs, so far this year which includes 781 final approvals and 190 tentative approvals.
Ever since the Hatch-Waxman Act came into being, the generic drugs have saved billions for both patients and healthcare systems alike and accounted for 88% of the prescription drugs sale in the United States alone.