0001104659-13-043597.txt : 20130521 0001104659-13-043597.hdr.sgml : 20130521 20130521165641 ACCESSION NUMBER: 0001104659-13-043597 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20130521 ITEM INFORMATION: Other Events FILED AS OF DATE: 20130521 DATE AS OF CHANGE: 20130521 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: 13862465 BUSINESS ADDRESS: STREET 1: 100 HAYDEN AVENUE CITY: LEXINGTON STATE: MA ZIP: 02421 BUSINESS PHONE: 6174983300 MAIL ADDRESS: STREET 1: 100 HAYDEN AVENUE CITY: LEXINGTON STATE: MA ZIP: 02421 FORMER COMPANY: FORMER CONFORMED NAME: ADVANCED MAGNETICS INC DATE OF NAME CHANGE: 19920703 8-K 1 a13-12978_28k.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): May 21, 2013

 

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.)

 

100 Hayden Avenue

 

 

Lexington, Massachusetts

 

02421

(Address of principal executive offices)

 

(Zip Code)

 

(617) 498-3300

(Registrant’s telephone number, including area code)

 

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.

 

AMAG Pharmaceuticals, Inc. (“AMAG”) has been made aware by Takeda Pharma AG, the exclusive product distributor of ferumoxytol in Switzerland, that it is recalling one specific batch of Rienso® (ferumoxytol) from the Swiss market. This decision is based on a cluster of four post-marketing adverse event reports in Switzerland concerning hypersensitivity reactions of varying severity following the administration of Rienso® from this batch.  One of these cases included a report of a fatality. The batch was only distributed to and sold in Switzerland and the recall is limited to the specific batch and specifically Switzerland. Takeda Pharmaceutical Company Limited (“Takeda”) is also the exclusive distributor of this product in Canada and the European Union and Takeda Pharma AG is a wholly owned subsidiary of Takeda.

 

Rienso, like other IV irons, may cause serious hypersensitivity reactions, including anaphylactic reactions.   AMAG and Takeda are investigating the specific Swiss batch of Rienso as well as gathering additional information regarding the four reported adverse events.  New batches of Rienso may be introduced into the Swiss market based upon the information gathered and with the approval of Swissmedic.

 

By filing this information, AMAG makes no admission as to the materiality of any information in this report. The information contained in this report is intended to be considered in the context of AMAG’s filings with the Securities and Exchange Commission and other public announcements that AMAG makes, by press release or otherwise, from time to time. AMAG undertakes no duty or obligation to publicly update or revise the information contained in this report, although it may do so from time to time as its management believes is appropriate. Any such updating may be made through the filing of other reports or documents with the Securities and Exchange Commission, through press releases or through other public disclosure.

 

2


 

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/ Scott B. Townsend

 

General Counsel and Senior Vice President of Legal Affairs

 

 

 

 

 

Date: May 21, 2013

 

3