AcuCort Receives Renewed FDA Small Business Waiver
The U.S. Food and Drug Administration (FDA) has granted AcuCort a renewed Small Business Waiver (SBW). This decision exempts the company from an application fee for its planned New Drug Application (NDA), a fee estimated at SEK 16 million.
The U.S. Food and Drug Administration (FDA) has granted AcuCort a renewed Small Business Waiver (SBW). This approval exempts the company from a significant application fee for its upcoming New Drug Application (NDA), a fee that would otherwise cost approximately SEK 16 million (roughly $1.5 million USD).
The FDA had previously awarded AcuCort an SBW. As the prior waiver had expired, the company reapplied for renewal earlier this year, a request that has now been approved. This financial relief is a notable step as AcuCort prepares to submit its NDA, anticipated in 2026.
Earlier this year, AcuCort also announced an agreement with the FDA confirming no additional studies would be required before the NDA submission. The company is currently finalizing its application for Isentress, a treatment for acute, life-threatening hypersensitivity reactions like anaphylaxis.
The renewed waiver reduces AcuCort's immediate financial obligations as it progresses towards seeking U.S. market approval for its drug.