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FDA Approves Labeling Update of Abilify Maintena®

December 8, 2014 8:30 am | News | Comments

Otsuka Pharmaceutical and H. Lundbeck A/S announced that FDA approved the labeling update of Abilify Maintena® for extended-release injectable suspension. The approval was based on results from a controlled clinical study of acutely relapsed adults with schizophrenia.

Lundbeck to Acquire Chelsea Therapeutics

May 8, 2014 8:54 am | News | Comments

Under the terms of the agreement, Lundbeck will commence a tender offer for all outstanding...

Lundbeck’s NDA for Intravenous Carbamazepine Accepted by FDA

March 10, 2014 11:07 am | News | Comments

Lundbecktoday announced that the FDA has accepted for review a New Drug Application (NDA) for...

Genmab Reaches Fourth Milestone in Lundbeck Collaboration

December 6, 2013 8:36 am | News | Comments

Genmab A/S announced today it had reached an in vivo pre-clinical milestone in the collaboration...

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Lundbeck and Otsuka Further Expand Alzheimer's Disease Alliance

March 26, 2013 8:03 am | News | Comments

H. Lundbeck and Otsuka Pharmaceutical today announced a license and development agreement for Lu AE58054, a selective 5HT 6 receptor antagonist currently in development for the treatment of Alzheimer's disease. Under the terms of the agreement, Lundbeck will grant Otsuka co-development and co-commercialization rights to Lu AE58054.

Otsuka Expanding Existing Collaboration with Lundbeck

March 7, 2013 8:29 am | News | Comments

Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S today outlined co-promotion plans and summarized the overall progress in their global alliance at a session in Japan with representatives from domestic and international media organizations.

FDA Approves Once-Monthly ABILIFY MAINTENA™

March 1, 2013 7:58 am | News | Comments

Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S announced the FDA has approved ABILIFY MAINTENA™ (aripiprazole) for extended- release injectable suspension, an intramuscular (IM) depot formulation indicated for the treatment of schizophrenia. ABILIFY MAINTENA is the first dopamine D2 partial agonist approved as a once- monthly injection.


Recordati Completes Acquisition of Lundbeck’s US Portfolio of Products

January 21, 2013 2:51 am | News | Comments

Recordati has announced the successful conclusion of the acquisition of all rights concerning a portfolio of products indicated for the treatment of rare and other diseases and marketed mainly in the United States of America, from Lundbeck LLC.

States: Death-Penalty Drug Scramble, Higher Cost

July 11, 2011 4:44 am | by ANDREW WELSH-HUGGINS,AP Legal Affairs Writer | News | Comments

COLUMBUS, Ohio (AP) — States not only are having an increasingly difficult time getting the injectable drugs to carry out death sentences, they're also paying as much as 10 times more for the chemicals as in years past.

Lundbeck to Restrict Use of Death Penalty Drug

July 1, 2011 4:43 am | by JAN M. OLSEN,Associated Press | News | Comments

COPENHAGEN, Denmark (AP) — Lundbeck A/S is changing its distribution system to stop one of its drugs from being used to execute prisoners in the United States.

Oklahoma to Continue Using Sedative in Executions

January 28, 2011 3:39 am | by TIM TALLEY,Associated Press | News | Comments

OKLAHOMA CITY (AP) — Oklahoma prison officials will continue using a sedative as part of the state's three-drug lethal injection protocol despite objections from the drug's manufacturer, a spokesman for the state Department of Corrections said Thursday.

Sedative Maker Deplores Execution Use

January 27, 2011 5:11 am | by ANDREW WELSH-HUGGINS,AP Legal Affairs Writer | News | Comments

The sole U.S. manufacturer of a sedative that Ohio plans to use to execute death row inmates — and that Oklahoma already uses to do so — said Wednesday it opposes the practice and has asked both states to stop using the drug.


Vernalis plc and Lundbeck to Collaborate on Drug Discovery

December 16, 2010 3:40 am | News | Comments

Vernalis plc and H. Lundbeck A/S have entered into a drug discovery collaboration utilising Vernalis' fragment and structure-based drug discovery platform against LRRK2, a kinase target. Inhibitors of this target may have potential utility in the treatment of neurodegenerative indications, such as Parkinson's Disease.

Lundbeck and Merck Sign Exclusive Commercialization Agreement for SYCREST Sublingual Tablets

October 12, 2010 4:55 am | News | Comments

H. Lundbeck A/S (Lundbeck) and Merck, known outside the United States and Canada as MSD, today announced a commercialization agreement for SYCREST(R) (asenapine) sublingual tablets (5 mg, 10 mg).

Lunbeck Recall Two Lots of NeoProfen® Injection Resulting in Temporary Product Shortage

August 2, 2010 4:38 am | News | Comments

Lundbeck Inc. has voluntarily recalled two lots of NeoProfen® (ibuprofen lysine) Injection that failed to meet a visible particulate quality requirement. These two lots are the only lots currently available to prescribers and therefore the recall will result in a temporary drug shortage.

APP Pharmaceuticals Receives Approval for Indomethacin for Injection

March 23, 2010 5:13 am | News | Comments

APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., has received approval from the FDA to market Indomethacin for Injection. Indomethacin is therapeutically equivalent to the reference-listed drug INDOCIN I.V., by Lundbeck, Inc.

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