In exchange, Acorda will pay NeurogesX $7 million upon closing and up to an additional $5 million in post-closing milestone payments: $2 million upon FDA approval of NGX-1998 prior to Dec. 31, 2016, and $3 million if net sales of NGX-1998 in Acorda's territory (which excludes Europe, Africa and the Middle East) reach $100 million during the first 12 months on the market

filed suit against Actavis in U.S. District Court for the District of Delaware to prevent Actavis from commercializing the product, resulting in a stay of final FDA approval of Actavis's ANDA for up to 30 months

Stivarga won FDA approval last year. (See BioWorld Today, Sept. 28, 2012

Xeljanz gained FDA approval last year. (See BioWorld Today, Nov. 8, 2012

Dako, of Glostrup, Denmark, part of Agilent Technologies Co., received FDA approval for the addition of Kadcyla (ado-trastuzumab emtansine) to the labeling of two Dako companion diagnostic assays

Dako, of Glostrup, Denmark, part of Agilent Technologies Co., received FDA approval for the addition of Kadcyla (ado-trastuzumab emtansine) to the labeling of two Dako companion diagnostic assays

The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis' ANDA for up to 30 months from the date the plaintiffs received notice of Actavis' ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities

Pending FDA approval, the company intends to initiate a Phase II study in late 2013 or early 2014. (See BioWorld Today, Feb. 15, 2011, and Oct. 29, 2012

Baxter International Inc., of Deerfield, Ill., said it submitted a biologics license application supplement to the FDA for approval of prophylaxis treatment of FEIBA NF (anti-inhibitor coagulant complex), nanofiltered and vapor-heated, in patients with hemophilia A or B and inhibitors

He pegged the odds of FDA approval at less than 50 percent, but added "there is now the opportunity for a major upside surprise that did not exist previously

Vascepa gained FDA approval last year

QRxPharma Ltd., of Sydney, Australia, said it clarified the steps necessary with the FDA for approval of pain candidate MoxDuo, with a new drug application resubmission expected this quarter and a new PDUFA date set for the third quarter

QRxPharma Ltd., of Sydney, Australia, said it clarified the steps necessary with the FDA for approval of pain candidate MoxDuo, with a new drug application resubmission expected this quarter and a new PDUFA date set for the third quarter

6,545,040, or the date Glenmark receives final FDA approval of its ANDA

The sNDA requests FDA approval to expand the indication for ferumoxytol beyond the current indication for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease to all adult patients with IDA who have failed or could not tolerate oral iron treatment

The FDA approval was based on a clinical data package involving more than 1 ,600 patients and subjects

Sucampo Pharmaceuticals Inc., of Bethesda, Md., received FDA approval of an supplemental new drug application for Rescula (unoprostone isopropyl ophthalmic solution) for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension

Brinavess has received approval in the European Union for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults but has not received FDA approval...Somaxon gained FDA approval of insomnia product Silenor but has struggled to gain traction in the commercial market, despite a U.S

The news came late Thursday, shortly after the company disclosed FDA approval of Cometriq in MTC