Last month, the FDA asked for additional information before making a determination about a new drug application filing under Subpart H accelerated approval. (See BioWorld Today, April 17, 2013

plc, of Dublin, Ireland, said the FDA will convene an advisory committee on Oct. 16 in connection with the agency's review of the supplemental new drug application seeking approval for the use of Vascepa (icosapent ethyl) capsules as an adjunct to diet in the treatment of adult patients with high triglycerides...Aurigene Discovery Technologies, of Bangalore, India, and Debiopharm Group, of Lausanne, Switzerland, nominated a development candidate, Debio 0617B, a small molecule targeting an

Biosimilar sponsors must pay a $195,880 initial biological product development (BPD) fee when they submit an investigational new drug application that the FDA determines is intended to support a biosimilar or within five days of the agency granting a development meeting request

The company's concerns about broadening the 351(a) path, echoed by the Pharmaceutical Research and Manufacturers of America (PhRMA), were kicked up by a statement in the guidance, which said the FDA would determine whether an investigative new drug application (IND) is intended to support a biosimilar or a future biologics license application (BLA

Redhill Biopharma Ltd., of Tel-Aviv, Israel, said the FDA accepted its new drug application for RHB-103, an oral thin film formulation of rizatriptan, for the treatment of acute migraine, co-developed by Intelgenx Corp., of Saint Laurent, Quebec

Perosphere Inc., of Mount Kisco, N.Y., recently received FDA clearance of its investigational new drug application to start clinical testing of PER977 to reverse anticoagulant activity of unfractionated heparin low-molecular-weight heparins, fondaparinux and Factor Xa- and IIa inhibitors

Investors clearly had hoped that the agency would sign off on that plan, clearing a path for a new drug application (NDA) for migalastat monotherapy this year based on those data

Prior to the submission of an investigational new drug application, Genmab may elect to retain equal ownership of the product...in filing a patent infringement lawsuit against Mylan Pharmaceuticals Inc., of Pittsburgh, which filed an abbreviated new drug application (ANDA) seeking to market a generic version of Azasite (azithromycin 1 percent ophthalmic solution

Assuming positive data, Cempra will be able to file a new drug application for solithromycin based on data from one oral study and one I.V.-to-oral study

The new cash is expected to let San Diego-based Mast reach top-line data, said Brandi Roberts, chief financial officer, although it "probably won't get us through filing the new drug application and getting ready for commercialization

Perosphere Inc., of Mount Kisco, N.Y., recently received FDA clearance of its investigational new drug application to start clinical testing of PER977 to reverse anticoagulant activity of unfractionated heparin low-molecular-weight heparins, fondaparinux and Factor Xa- and IIa inhibitors

said the FDA granted priority review to its new drug application for sofosuvir for the treatment of hepatitis C virus infection

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

Cornerstone Therapeutics Inc., of Cary, N.C., said it received on June 11 a Paragraph IV notice letter from Exela Pharma Sciences LLC, of Lenoir, N.C., advising the firm of Exela's filing of a supplemental new drug application for use of an injectable form of nicardipine hydrochloride in 9 percent sodium chloride, a generic version of Cornerstone's Cardene I.V

Trius will incorporate the results into its new drug application for tedizolid for the treatment of acute bacterial skin and skin structure infections, which it plans to submit to the FDA in the second half of 2013

The company expects to use the remainder of the funding for filing its new drug application (NDA) for tavaborole, a candidate for onychomycosis, and conducting additional clinical studies

In May, the company completed Phase III trials in Taiwan and China under TFDA and CFDA authority and said a new drug application (NDA) had been filed in both countries

Biotie may exercise the option right up until the start of the pivotal pharmacokinetic studies that will form the basis of a 505(b)(2) new drug application, but no later than Dec. 3, 2014

Salix Pharmaceuticals Ltd., of Raleigh, N.C., and Progenics Pharmaceuticals Inc., of Tarrytown, N.C., said the FDA will hold an advisory committee meeting to review Salix's supplemental new drug application (sNDA) for Relistor (methylnaltrexone bromide) subcutaneous injection in opioid-induced constipation (OIC) for patients with chronic pain