`
`Time Sensitive Patent Information
`
`Central Document Room
`_ Center for Drug Evaluation and Research
`Food and Drug Administration
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
`
`Re C e lV9 d
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`'
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`FEB i3 1 2019
`~
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`CDR
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`RE: Withdrawal and Request to Remove US. Patent No. 9,161,926 from Listing for NDA
`No. 207154 for ACZONE® (dapsone) Gel, 7.5%, for Topical Use
`
`Dear Sir or Madam:
`
`I
`
`In accordance with 21 C.F.R. § 314.53(f)(2), Almirall LLC, formerly Aqua Pharmaceuticals
`LLC, withdraws and requests removal of U. S. Patent No. 9,161,926 from the Food and Drug
`Administration’s patent listing information for NDA No. 207154 for prescription ACZONE®
`(dapsone) Ge], 7.5%, for topical use.
`
`NDA No.: N207154
`Product(s) to which request applies: ACZONE® (dapsone) Gel, 7.5%, for topical use
`Patent No.: USP 9,161,926
`
`Please note that, as shown in the enclosed document,-NDA holder Aqua Pharmaceuticals LLC
`changed its name to Almirall LLC on September 27, 2018. All rights in NDA No. 207154 are
`now owned by Almirall LLC, who is committed to all agreements, promises, and conditions
`made by Aqua Pharmaceuticals LLC regarding the NDA and contained thelein. Almirall LLC
`has a complete copy of the NDA, including supplements and records that are required to be kept
`underZI C.F.R §3l4. 81.
`
`Sincerely,
`‘W '
`
`Ron Menezes
`
`President and General Manager of Almirall LLC
`On Behalf of Almirall LLC, formerly Aqua Pharmaceuticals LLC
`
`Received
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