UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): June 15, 2016
VANDA PHARMACEUTICALS INC.
(Exact name of Registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
| 001-34186 | 03-0491827 | |
| (Commission File No.) | (IRS Employer Identification No.) |
2200 Pennsylvania Avenue NW
Suite 300E
Washington, DC 20037
(Address of principal executive offices and zip code)
Registrant’s telephone number, including area code: (202) 734-3400
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| Item 8.01. | Other Events. |
On June 15, 2016, Vanda Pharmaceuticals Inc. (“Vanda”) issued a press release announcing that the U.S. Food and Drug Administration has granted three years of marketing exclusivity for changes to the labeling of Fanapt® relating to maintenance treatment of schizophrenia in adults. The full text of this press release is filed as Exhibit 99.1 to this Current Report on Form 8-K.
| Item 9.01. | Financial Statements and Exhibits. |
| (d) | Exhibits |
| Exhibit No. |
Description | |
| 99.1 | Press Release of Vanda Pharmaceuticals Inc. dated June 15, 2016. | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Dated: June 15, 2016 | VANDA PHARMACEUTICALS INC. | |||||
| By: | /s/ Richard Gulino | |||||
| Name: | Richard Gulino | |||||
| Title: | Senior Vice President, General Counsel | |||||
Exhibit 99.1
FDA Grants Fanapt® Three Years of Marketing Exclusivity for Labeling Changes Relating to Maintenance Treatment of Schizophrenia
WASHINGTON, June 15, 2016 /PRNewswire/ — Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has granted three years of marketing exclusivity for the changes related to the supplemental New Drug Application (sNDA) that was recently approved by FDA. On May 26, 2016, Vanda announced that FDA had approved Vanda’s sNDA for Fanapt®, modifying and expanding the prescribing information for the use of Fanapt® as a maintenance treatment of schizophrenia in adults.
The FDA added this entry to the Fanapt® Orange Book listing providing exclusivity until May 26, 2019 based upon three years from the sNDA approval date.
About Vanda Pharmaceuticals Inc.
Vanda is a specialty pharmaceutical company focused on the development and commercialization of novel therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda, please visit www.vandapharma.com.
Corporate Contact:
Jim Kelly
Senior Vice President and Chief Financial Officer
Vanda Pharmaceuticals Inc.
(202) 734-3428
jim.kelly@vandapharma.com
Media Contact:
Alexandra Peterson
Senior Vice President, Health Practice Leader
Makovsky
(212) 508-9709
apeterson@makovsky.com
SOURCE Vanda Pharmaceuticals Inc.