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# Petition Seeks Removal of Blocks on Generic Seroquel
- URL: https://www.fdaweb.com/petition-seeks-removal-of-blocks-on-generic-seroquel/
- Published: 2017-02-10T12:00:00.000Z
- Updated: 2026-09-14T22:05:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137957

A just-filed citizen petition has asked FDA to determine whether the 180-day marketing exclusivity for a Handa ANDA for quetiapine fumerate extended-release tablets has effectively been forfeited for failing to obtain tentative approval within 30 months. It also asks the agency to determine whether Handa is not actively pursuing approval of its ANDA, which could make the approval of subsequent ANDAs immediately effective.

  
According to the [petition](https://www.regulations.gov/contentStreamer?documentId=FDA-2017-P-0868-0001&attachmentNumber=1&disposition=attachment&contentType=pdf&ref=fdaweb.com), submitted by **David Wong** as an individual (no further identification supplied), the 180-day exclusivity period was triggered and began on 11/1/2016 when Par Pharmaceuticals, which acquired and controls Handa ANDA 090482, began commercial marketing of an authorized generic of the same drug. Wong says he “seeks to accelerate approval of tentatively approved ANDAs, which were blocked by first-to-file status of Handa ANDA 090482.”

  
Quetiapine fumerate is the active ingredient in AstraZeneca’s Seroquel, indicated for adults as an add-on treatment to an antidepressant for patients with major depressive disorder. It is also approved for acute depressive episodes in bipolar disorder patients.