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

NDA 208294
NDA APPROVAL
Pearl Therapeutics, Inc.
4222 Emperor Boulevard Suite 560
Durham, NC 27703
Attention:

Tracy Fischer, PharmD
Senior Director, Regulatory Affairs

Dear Dr. Fischer:
Please refer to your New Drug Application (NDA) dated June 25, 2015, received June 25, 2015,
and your amendments, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and
Cosmetic Act (FDCA) for Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) 9/4.8
mcg Inhalation Aerosol.
This new drug application provides for the use of Bevespi Aerosphere (glycopyrrolate and
formoterol fumarate) 9/4.8 mcg Inhalation Aerosol for the long-term maintenance treatment of
airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) including
chronic bronchitis and/or emphysema.
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.
WAIVER OF HIGHLIGHTS SECTION
We are waiving the requirements of 21 CFR 201.57(d)(8) regarding the length of Highlights of
prescribing information. This waiver applies to all future supplements containing revised
labeling unless we notify you otherwise.

 NDA 208294
Page 2

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, text for the
Instructions for Use, Medication Guide). 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
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 immediate 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 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 208294.” Approval of this
submission by FDA is not required before the labeling is used.
Marketing the product(s) with 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 pediatric studies requirement for this application because necessary studies
are impossible or highly impracticable. Chronic obstructive pulmonary disease does not exist in
the pediatric population.

 NDA 208294
Page 3

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,
Medication Guide, and patient PI (as applicable) 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).

 NDA 208294
Page 4

If you have any questions, call Brandi Wheeler, Regulatory Project Manager, at (301) 796-4495.
Sincerely,
{See appended electronic signature page}

Badrul A. Chowdhury, MD, PhD
Director
Division of Pulmonary, Allergy, and
Rheumatology Products
Office of Drug Evaluation II
Center for Drug Evaluation and Research

Enclosure(s):
Content of Labeling
Carton and Container Labeling