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# Fera Asks for Sole Exclusivity on Generic Levothyroxine
- URL: https://www.fdaweb.com/fera-asks-for-sole-exclusivity-on-generic-levothyroxine/
- Published: 2017-06-27T12:00:00.000Z
- Updated: 2026-09-14T22:31:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139038

Fera Pharmaceuticals is asking FDA not to approve any ANDA for levothyroxine injection 100 mcg/vial and 500 mcg/vial until the company’s 180-day exclusivity has expired. In its [petition](https://www.regulations.gov/contentStreamer?documentId=FDA-2017-P-3950-0001&attachmentNumber=1&contentType=pdf.&ref=fdaweb.com) Fera says the agency should not approve any ANDA, including InnoPharma’s, because Fera is the sole “first applicant” that is entitled to 180-day exclusivity and no ANDA is approvable until that exclusivity expires.

The company asks FDA to declare that InnoPharma’s ANDA does not share exclusivity with Fera due to InnoPharma’s Paragraph 4 certification date and InnoPharma’s premature notice letter.