`
`TimeSensitive Patent Information
`Central Document Room
`_ Center for Drug Evaluation and Research
`Food and Drug Administration
`$901-B Ammendale Road
`Beltsville, MD 20705-1266
`
`Received
`FEB 01 2019
`
`-
`
`CDR
`
`RE: Withdrawal and Request to Remove U.S. Patent No. 9,161,926 from Listing for NDA
`No. 207154 for ACZONE®(dapsone) Gel, 7.5%, for Topical Use
`
`DearSir or Madam:
`
`—
`
`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) Gel, 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 therein. Almirall LLC
`has a complete copy ofthe NDA,including supplements and records that are required to be kept
`under 21 C.F.R. § 314.81.
`
`Sincerely,
`. aipe—
`
`Ron Menezes.
`President and General Manager ofAlmirall LLC
`On Behalf of Almirall LLC, formerly Aqua Pharmaceuticals LLC
`
`|
`
`Received
`
`een ni nia
`FEB 04 2019
`
`CDR
`
`
`
`
`
`
`
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