US COPD Coalition

FDA’s Office of Generic Drugs Releases Its 2016 Annual Report


The US Food & Drug Administration’s Office of Generic Drugs (OGD) has just released its 2016 Annual Report, and it was a banner year for generic drug approvals. The OGD approved 630 abbreviated new drug applications and tentatively approved an additional 183, which sets a record for generic drug approvals.

According to Kathleen Uhl, MD, the Director of the OGD, it is important to reduce the time it takes to approve generic drugs, but the speed with which they are approved must be balanced by the need to assure they are safe and effective. “It is exciting to see the number of approvals and tentative approvals continuing to rise, but our main focus is always to ensure the safety, effectiveness, and quality of FDA-approved drugs. FDA-approved generic drugs account for 89 percent of prescriptions dispensed in the United States. They must meet high standards to ensure that they can be substituted for the brand-name drug”.