A new report on the U.S. Food and Drug Administration's (FDA) generic drug program highlights the agency's all-time record number of approvals for fiscal year 2018.
Released by acting FDA commissioner Dr. Ned Sharpless, the report showed that a total of 1,171 generic drug approvals – 935 full approvals and 236 tentative approvals – were been granted for the fiscal year 2019. Furthermore, the FDA approved 125 applications for first generics of medicines that had no generic competition.
Approvals for first generics in the fiscal year 2018 comprised of emergency opioid overdose treatment and medications to treat conditions such as breast cancer, pulmonary arterial hypertension, seizures, depression and various infections.
“The FDA is approving increasing numbers of complex generic drugs, which are harder to copy and traditionally have lacked competition,” Sharpless said in a press release.
Sharpless also mentioned that proper assessment and monitoring is being done to ensure safety, effectiveness and quality of the generic drugs to which consumers are entitled. Additional guidelines and policies are also being looked in to guarantee that the program remains vibrant and the market stable, allowing opportunities for consumers to have greater access to quality and affordable medicines.