0001104659-16-133752.txt : 20160722 0001104659-16-133752.hdr.sgml : 20160722 20160721194823 ACCESSION NUMBER: 0001104659-16-133752 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20160719 ITEM INFORMATION: Other Events FILED AS OF DATE: 20160722 DATE AS OF CHANGE: 20160721 FILER: COMPANY DATA: COMPANY CONFORMED NAME: AMAG PHARMACEUTICALS INC. CENTRAL INDEX KEY: 0000792977 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 042742593 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-10865 FILM NUMBER: 161778349 BUSINESS ADDRESS: STREET 1: 1100 WINTER STREET CITY: WALTHAM STATE: MA ZIP: 02451 BUSINESS PHONE: 6174983300 MAIL ADDRESS: STREET 1: 1100 WINTER STREET CITY: WALTHAM STATE: MA ZIP: 02451 FORMER COMPANY: FORMER CONFORMED NAME: ADVANCED MAGNETICS INC DATE OF NAME CHANGE: 19920703 8-K 1 a16-15333_18k.htm 8-K

 

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 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): July 19, 2016

 

AMAG PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware

(State or other jurisdiction of incorporation)

 

001-10865

 

04-2742593

(Commission File
Number)

 

(IRS Employer Identification
No.)

 

1100 Winter St.

 

 

Waltham, Massachusetts

 

02451

(Address of principal executive
offices)

 

(Zip Code)

 

(617) 498-3300

(Registrant’s telephone number, including area code)

 

 

(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:

 

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o 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 July 19, 2016, AMAG Pharmaceuticals, Inc. (the “Company”) was notified by the U.S. Food and Drug Administration that the Prior Approval Supplement for Coldstream Laboratories, Inc. (which is owned by Piramal Enterprises Limited) was approved for the manufacture of the single-dose, 1 mL, preservative-free formulation of Makena® (hydroxyprogesterone caproate injection). This approval provides the Company with an alternative manufacturer for the single-dose formulation of Makena.

 

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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.

 

 

AMAG PHARMACEUTICALS, INC.

 

 

 

By:

/s/ Joseph D. Vittiglio, Esq.

 

 

Joseph D. Vittiglio, Esq.

 

 

Senior Vice President, General Counsel and Secretary

 

 

 

 

Date: July 21, 2016

 

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