The AzaSite Plus and DexaSite Phase III programs also are expected to report data this year, and InSite is not averse to filing three new drug applications on its own

Titan submitted its new drug application for Probuphine to the FDA in October 2012 under the 505(b)(2) pathway

QRxPharma Ltd., of Sydney, Australia, said the FDA set a PDUFA date of Aug. 26 for the resubmitted new drug application seeking approval of Moxduo, an immediate-release dual opioid pain therapy that combines morphine and oxycodone

Slow enrollment and new data generated under a compassionate-use investigational new drug application led to the closure of the trial in January 2009

The company submitted a supplemental new drug application in December to expand the use to all adults with IDA who have failed or could not tolerate oral iron treatment. (See BioWorld Today, July 1, 2009

Spectrum is assuming responsibility for the ongoing trial and will be responsible for filing a new drug application, expected in the first half of 2014...The company anticipates that 1 kg will be sufficient to complete the upcoming investigational new drug application-enabling animal toxicity studies and Phase I trials

The company has also submitted new drug applications to the FDA for canagliflozin and for the fixed-dose combination therapy

investigational new drug application

Astellas exercised its right to terminate the program as part of the worldwide license agreement inked with Ambit in 2009. (See BioWorld Today, Dec. 21, 2009.) Over the next six months, the companies will work together to transfer management of ongoing clinical trials and their governing investigational new drug applications to Ambit, which will then regain all rights to the quizartinib clinical trial and development program

The company is prepping for a new drug application filing for AEZS-130, a ghrelin agonist that has shown potential as an oral diagnostic test for adult growth hormone deficiency

A new drug application is expected to be filed in the second quarter of this year, and Medicines intends to seek European approval before 2013 finishes

Acceptance of the questionnaire by the FDA allows Ampio or a pharmaceutical partner to file an investigational new drug application in the U.S...Assuming continued clinical success, Tris expects to file a new drug application in mid-2014

The company will allocate about $30 million to $35 million to development costs in preparation for a new drug application, to costs of increasing manufacturing capacity and validating manufacturing process, and to build commercial inventory

IND = Investigational new drug application...NDA = New drug application

A new drug application is expected later this year

In January the company completed a $287.5 million debt financing in preparation to make milestone payments to its partner GSK upon launch of their combination products developed under the two companies' 2002 collaboration around long-acting beta 2 agonists (LABAs) and bifunctional muscarinic antagonist-beta2 agonists (MABAs). (See BioWorld Today, Jan. 18, 2013.) Theravance may also be receiving positive vibes from a January PADAC recommendation that clinical data included in a new drug

Its use will be extended to efficacy supplements for new/expanded indications in fiscal 2016 and to all original new drug applications the following year

The company has also submitted new drug applications to the FDA for canagliflozin and for the fixed-dose combination therapy

AMAG Pharmaceuticals Inc., of Lexington, Mass., said the FDA accepted for review its supplemental new drug application (sNDA) for Feraheme (ferumoxytol) injection for intravenous use