DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208424 NDA APPROVAL G. Pohl Boskamp GmbH & Co. KG c/o Espero Pharmaceuticals, Inc. Attention: Quang Pham Chief Executive Officer 14286-19 Beach Blvd #270 Jacksonville, Florida 32250 Dear Mr. Pham: Please refer to your New Drug Application (NDA) dated 6 August 2015, received 10 August 2015 and your amendments, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for GoNitro (nitroglycerin) sublingual powder, 400 mcg per packet. This new drug application provides for the use of GoNitro (nitroglycerin) sublingual powder for the acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. 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 instructions for use). 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/UCM0723 92.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 and/or carton and immediate container labels submitted on 6 June 2016, 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 208424.” Approval of this submission by FDA is not required before the labeling is used. Reference ID: 3943120 NDA 208424 Page 2 Marketing the product with FPL that is not identical to the approved labeling text may render the product misbranded and an unapproved new drug. ADVISORY COMMITTEE Your application for GoNitro was not referred to an FDA advisory committee because sublingual nitroglycerin is an approved drug and GoNitro is a different dosage form intended for sublingual administration. Hence, outside expertise was not necessary. 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 study requirement for this application as there is no objective evidence for the presence of angina in the setting of coronary artery disease in the pediatric population. Therefore, pediatric studies for this indication would be impossible or highly impracticable. 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/UCM443 702.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 Reference ID: 3943120 NDA 208424 Page 3 We remind you that you must comply with reporting requirements for an approved NDA (21 CFR 314.80 and 314.81). If you have any questions, please call Bridget Kane, Regulatory Project Manager, at (240) 402-2170. Sincerely, {See appended electronic signature page} Norman Stockbridge, MD, PhD Director Division of Cardiovascular and Renal Products Office of Drug Evaluation I Center for Drug Evaluation and Research Enclosures: Content of Labeling Carton and Container Labeling Cc: G. Pohl-Boskamp GmbH & Co. KG Attention: Dr. Ulrike Küper Director of Regulatory Affairs Kieler Straße 11 Hohenlockstedt - Schleswig-Holstein Germany 25551 Reference ID: 3943120 --------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature. --------------------------------------------------------------------------------------------------------/s/ ---------------------------------------------------NORMAN L STOCKBRIDGE 06/08/2016 Reference ID: 3943120 (