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# Bayer Wants 30-Month Stay of Apotex ANDA
- URL: https://www.fdaweb.com/bayer-wants-30-month-stay-of-apotex-anda/
- Published: 2022-04-07T12:00:00.000Z
- Updated: 2026-09-14T17:39:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151546

Bayer is petitioning FDA to confirm that it will stay final approval of an Apotex ANDA citing Bayer’s Astelin (azelastine HCl) nasal spray as the reference-listed drug until the expiration of the 30-month period beginning on the date Bayer received the Apotex Paragraph IV certification. The Bayer 4/5 [petition](https://downloads.regulations.gov/FDA-2022-P-0536-0001/attachment%5F1.pdf?ref=fdaweb.com) says it is entitled to the 30-month stay of approval because it has met all three requirements for a stay stated in the law.

Bayer makes the point that its submission of patent information with the original NDA satisfies the third condition for eligibility for a stay regardless of whether Apotex submitted its original ANDA before Bayer submitted FDA-3542 following the agency’s approval of the Bayer NDA.