DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Silver Spring MD 20993

NDA 208251/Original -1
NDA APPROVAL
Laboratorios SALVAT, S.A.
c/o Premier Research
Attention: Linda Hibbs
Associate Director, Global Regulatory Affairs and Operations
One Park Drive, STE 150
Durham, NC 27709

Dear Ms. Hibbs:
Please refer to your New Drug Application (NDA) dated June 30, 2015, received June 30, 2015
and your amendments, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and
Cosmetic Act (FDCA) for Otovel (ciprofloxacin 0.3% and fluocinolone acetonide 0.025%) Otic
Solution.
NDA 208251 provides for the use of Otovel (ciprofloxacin 0.3% and fluocinolone acetonide
0.025%) Otic Solution for the following indications which, for administrative purposes, we have
designated as follows:
  NDA 208251/Original 1 - Treatment of Acute Otitis Media with Tympanostomy tubes in
pediatric patients (aged 6 months and older)
(b) (4)

The subject of this action letter is NDA 208251/Original 1.

(b) (4)

We have completed our review of this application, as amended. It is approved, effective on the
date of this letter, for use as recommended in the enclosed agreed-upon labeling text.
CONTENT OF LABELING
As soon as possible, but no later than 14 days from the date of this letter, submit the content of
labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA
automated drug registration and listing system (eLIST), as described at
http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
of labeling must be identical to the enclosed labeling (text for the package insert and text for the
patient package insert). Information on submitting SPL files using eLIST may be found in the
guidance for industry SPL Standard for Content of Labeling Technical Qs and As, available at

Reference ID: 3924675

 NDA 208251-1
Page 2

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
CM072392.pdf.
The SPL will be accessible via publicly available labeling repositories.
CARTON AND IMMEDIATE CONTAINER LABELS
Submit final printed carton and container labels that are identical to the enclosed carton and
immediate container labels as soon as they are available, but no more than 30 days after they are
printed. Please submit these labels electronically according to the guidance for industry titled
“Providing Regulatory Submissions in Electronic Format – Human Pharmaceutical Product
Applications and Related Submissions Using the eCTD Specifications (June 2008).”
Alternatively, you may submit 12 paper copies, with 6 of the copies individually mounted on
heavy-weight paper or similar material. For administrative purposes, designate this submission
“Final Printed Carton and Container Labels for approved NDA 208251.” Approval of this
submission by FDA is not required before the labeling is used.
Marketing the product(s) with final printed labeling (FPL) that is not identical to the approved
labeling text may render the product misbranded and an unapproved new drug.
REQUIRED PEDIATRIC ASSESSMENTS
Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new
active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of
administration are required to contain an assessment of the safety and effectiveness of the
product for the claimed indication(s) in pediatric patients unless this requirement is waived,
deferred, or inapplicable.
We are waiving the requirement for pediatric studies for the ages 0 to 6 months because
necessary studies are impossible or impracticable. Myringotomy with tympanostomy tube
placement is generally not performed in children less than 6 months of age.
POSTMARKETING COMMITMENT NOT SUBJECT TO THE REPORTING
REQUIREMENTS UNDER SECTION 506B
We remind you of your postmarketing commitment:
3071-1 

Submit tabulated results from the validation batches of the drug product
(ciprofloxacin and fluocinolone acetonide otic solution, 0.3 % / 0.025 %)
including actual yields for all unit operations and batch records along with results
from all in-process tests.

The timetable you submitted on April 8, 2016, states that you will conduct this study according
to the following schedule:
Final Report Submission:

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 NDA 208251-1
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Submit nonclinical and chemistry, manufacturing, and controls protocols and all postmarketing
final reports to this NDA 208251. In addition, under 21 CFR 314.81(b)(2)(vii) and
314.81(b)(2)(viii) you should include a status summary of each commitment in your annual
report to this NDA. The status summary should include expected summary completion and final
report submission dates, any changes in plans since the last annual report, and, for clinical
studies/trials, number of patients entered into each study/trial. All submissions, including
supplements, relating to these postmarketing commitments should be prominently labeled
“Postmarketing Commitment Protocol,” “Postmarketing Commitment Final Report,” or
“Postmarketing Commitment Correspondence.”
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,
and patient package insert to:
OPDP Regulatory Project Manager

Food and Drug Administration 

Center for Drug Evaluation and Research

Office of Prescription Drug Promotion

5901-B Ammendale Road

Beltsville, MD 20705-1266

Alternatively, you may submit a request for advisory comments electronically in eCTD format.
For more information about submitting promotional materials in eCTD format, see the draft
Guidance for Industry (available at:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
CM443702.pdf ).
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. Form FDA 2253 is available at
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf.
Information and Instructions for completing the form can be found at
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For
more information about submission of promotional materials to the Office of Prescription Drug
Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
REPORTING REQUIREMENTS
We remind you that you must comply with reporting requirements for an approved NDA
(21 CFR 314.80 and 314.81).

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If you have any questions, call Carmen DeBellas, Regulatory Project Manager, at
(301) 796-1203.
Sincerely,
{See appended electronic signature page}

Sumathi Nambiar, MD, MPH
Director
Division of Anti-Infective Products
Office of Antimicrobial Products
Center for Drug Evaluation and Research

Enclosures:
Content of Labeling
Carton and Container Labeling

Reference ID: 3924675

 --------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed
electronically and this page is the manifestation of the electronic
signature.
--------------------------------------------------------------------------------------------------------/s/
---------------------------------------------------SUMATHI NAMBIAR
04/29/2016

Reference ID: 3924675