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# FDA Rejects Osmotica Petition on Venlafaxine Bioequivalence
- URL: https://www.fdaweb.com/fda-rejects-osmotica-petition-on-venlafaxine-bioequivalence/
- Published: 2017-03-27T12:00:00.000Z
- Updated: 2026-09-14T22:14:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138301

FDA has denied an Osmotica Pharmaceutical petition asking the agency to require that any ANDA seeking approval of venlafaxine HCl extended-release tablets 225 mg and referencing the company’s NDA-approved product demonstrate *in vivo* bioequivalence using the 225 mg strength. A 12/9/2016 [citizen petition](https://www.regulations.gov/contentStreamer?documentId=FDA-2016-P-4341-0001&attachmentNumber=1&disposition=attachment&contentType=pdf&ref=fdaweb.com) said the agency generally recommends that *in vivo* bioequivalence be demonstrated in the highest strength. “There does not appear to be a reason to depart from that general practice for venlafaxine HCl extended-release tablets,” it said. Osmotica said it produces the drug in 37.5 mg, 75 mg, 150 mg, and 225 mg strengths, and that the 150 mg strength is listed in the *Orange Book* as the reference-listed drug.

  
In the petition [denial letter](https://www.regulations.gov/document?D=FDA-2016-P-4341-0007&ref=fdaweb.com), FDA says it has issued product-specific bioequivalence (BE) recommendations for various drug products that do not recommend studies with the highest strength. “In light of that history, FDA’s recommendation, that applicants may conduct a single fed study using the 150mg strength to demonstrate BE equivalence for venlafaxine hydrochloride ER tablets, was scientifically appropriate.”