DEPARTMENT OF HEALTH & HUMAN SERVICES
`
`Public Health Service
`Food and Drug Administration
`Rockville, MD 20857
`
`NDA 21-794/S-005
`
`QL T USA, Inc.
`2579 Midpoint Drive
`Fort Collins, CO 80525
`Attention: Elyse Wolff, Vice President, PPM and Operations
`
`Dear Ms. Wolff:
`
`Please refer to your supplemental new drug application dated May 22, 2007, received May 23,
`2007, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for
`ACZONETM (dapsone) Gel, 5%.
`
`We acknowledge receipt of your submissions dated July 23, 2007, September 19, 2007, October
`31, 2007, December 12, 2007, and January 9, 2008.
`
`This supplemental new drug application provides for: 1) the removal of the requirement to screen
`all patients for glucose-6-phosphate dehydrogenase (G6PD) deficiency prior to initiating Aczone
`treatment; and 2) the removal of complete blood count and reticulocyte monitoring during
`Aczone treatment in patients that are G6PD deficient and in patients with a history of anemia.
`
`This supplement also reports on the following postmarketing study commitment:
`
`Study #I: Conduct a randomized, blinded, cross-over safety study with each acne patient treated
`with ACZONE Gel, 5%, for 12 weeks and vehicle for 12 weeks with at least a two week washout
`period in at least 50 evaluable G6PD deficient patients with acne vulgaris to further evaluate the
`risk of hematological adverse events with use of ACZONE Gel, 5%, in this population. Patients
`with rarer genetic abnormalities such as methemoglobin reductase or the congenital
`methemoglobinemias may also be studied. Obtain baseline, week 2, and end of each 12 week
`treatment period laboratory testing including complete blood count, reticulocyte counts,
`haptoglobin, and LDH levels. Plasma dapsone levels and N-acetyl dapsone levels should be
`obtained at baseline, week 2, and at the end of each 12 week treatment period. Additionally,
`plasma dapsone and its metabolite levels should be obtained in relation to adverse events which
`may be considered dapsone related.
`
`We completed our review of this application, as amended. This application is approved,
`effective on the date of this letter, for use as recommended in the agreed-upon labeling text. We
`also conclude that the above postmarketing study commitment is fulfilled.
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`Almirall EXHIBIT 2051
`Amneal v. Almirall
`IPR2018-00608
`
`

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`NDA 21-794/S-005
`Page 2
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`CONTENT OF LABELING
`
`As soon as possible, but no later that 14 days from the date of this letter, please submit the
`content of labeling [21 CFR 314.50(1)] in structured product labeling (SPL) fotmat as described
`at http://www.fda.gov/oc/datacouncil/spl.html that is identical to the enclosed labeling (text for
`the package insert and text for the patient package insert). Upon receipt, we will transmit that
`version to the National Library of Medicine for public dissemination. For administrative
`purposes, please designate this submission, "SPL for approved supplement NDA 21-794/S-005".
`
`PROMOTIONAL MATERIALS
`
`You may request advisory comments on proposed introductory advertising and promotional
`labeling. To do so, submit, in triplicate, a cover letter requesting advisory comments, the
`proposed materials in draft or mock-up form with annotated references, and the package insert
`to:
`
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Division of Drug Marketing, Advertising, and Communications
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
`
`As required under 21 CFR 314.81 (b )(3)(i), you must submit final promotional materials, and the
`package insert, at the time of initial dissemination or publication, accompanied by a Form FDA
`2253. For instruction on completing the Form FDA 2253, see page 2 of the Form. For more
`information about submissions of promotional materials to the Division of Drug Marketing,
`Advertising, and Communications (DDMAC), see www.fda/gov/cder/ddmac.
`
`LETTERS TO HEALTH CARE PROFESSIONALS
`
`If you issue a letter communicating important infotmation about this drug product (i.e., a "Dear
`Health Care Professional" letter), we request that you submit a copy of the letter to this NDA and
`a copy to the following address:
`
`MEDWATCH
`Food and Drug Administration
`5515 Security Lane
`HFD-001, Suite 5100
`Rockville, MD 20852
`
`REPORTING REQUIREMENTS
`
`We remind you that you must comply with repmiing requirements for an approved NDA
`(21 CPR 314.80 and 314.81).
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`NDA 21-794/S-005
`Page 3
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`If you have any questions, call Catherine Carr, Regulatory Project Manager, at (301) 796-2011.
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Stanka Kukich, M.D.
`Deputy Director
`Division of Dennatology and Dental Products
`Office of Drug Evaluation III
`Center for Drug Evaluation and Research
`
`Enclosure
`
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`

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`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`
`/s/
`
`Stanka Kukich
`3/14/2008 03:40:34 PM
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