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EX-99.1 - EX-99.1 - AMAG PHARMACEUTICALS, INC.a13-25954_3ex99d1.htm

 

 

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): January 21, 2014

 

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 cha nged 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 January 22, 2014, AMAG Pharmaceuticals, Inc. (the “Company”) issued a press release announcing that the Company received a complete response letter from the U.S. Food and Drug Administration (the “FDA”) for the Company’s supplemental New Drug Application seeking approval for a broader indication of Feraheme® (ferumoxytol) Injection, 510 mg, for the treatment of iron deficiency anemia (“IDA”) in adult patients who have failed or could not use oral iron (the “sNDA”).  In June 2009 Feraheme was approved for marketing by the FDA and is currently indicated for the treatment of IDA in adult patients with chronic kidney disease.  A copy of the press release is filed herewith as Exhibit 99.1 and is incorporated into this Item 8.01 by reference.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit Number

 

Description

99.1

 

Press release dated January 22, 2014.

 

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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 thereunto duly authorized.

 

 

AMAG PHARMACEUTICALS, INC.

 

 

 

By:

/s/ William K. Heiden

 

President and Chief Executive Officer

 

Date: January 22, 2014

 

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EXHIBIT INDEX

 

Exhibit Number

 

Description

99.1

 

Press release dated January 22, 2014.

 

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