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FDA Nixes REMS for Truvada and Its Generics

July 12, 2019

The FDA is scrapping the risk evaluation and mitigation strategy (REMS) for Gilead’s blockbuster HIV drug Truvada and its generics — so manufacturers will no longer have to include educational materials on the drug’s use.

The agency said it has evidence that healthcare professionals and at-risk individuals understand the risks of developing a resistant strain of HIV while using Truvada for pre-exposure prophylaxis (PrEP). In addition, the CDC offers treatment guidelines and educational material that patients can easily access.

The FDA has “reinforced to healthcare professionals and at-risk individuals that before starting PrEP with Truvada or [its generics], and during its use, health care professionals should routinely screen patients for HIV at least once every three months,” said Debra Birnkrant, director of FDA’s Division of Antiviral Products.

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