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# FDA Denies Vanda Petition to Delay Generic Fanapt
- URL: https://www.fdaweb.com/fda-denies-vanda-petition-to-delay-generic-fanapt/
- Published: 2016-11-30T12:00:00.000Z
- Updated: 2026-09-14T21:51:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137462

FDA has denied a Vanda Pharmaceuticals 9/7 petition asking that the agency not approve an ANDA referencing its atypical antipsychotic drug Fanapt (iloperidone) until expiration of a three-year exclusivity relating to Vanda’s clinical study of the drug for maintenance treatment of schizophrenia. The denial [letter](https://www.regulations.gov/contentStreamer?documentId=FDA-2016-P-2654-0008&attachmentNumber=1&disposition=attachment&contentType=pdf&ref=fdaweb.com) says the company contends that the three-year exclusivity FDA granted Vanda for its REPRIEVE study results protects both **(1)** the addition of information to Fanapt’s labeling about the product’s efficacy for maintenance treatment and **(2)** the deletion of statements describing a lack of evidence for maintenance treatment.

The letter says that the agency disagrees with the company’s claim about the scope of exclusivity it granted for the REPRIEVE study results and about the inquiry required in determining whether to approve an ANDA that carves out the protected information.

“The three-year exclusivity covers the addition of information to Fanapt’s labeling about the REPRIEVE study, which describes the product’s efficacy for maintenance treatment,” FDA says. “This exclusivity does not protect deletion of information regarding the lack of evidence of efficacy concerning maintenance therapy that was previously in the Fanapt labeling.”