Grayson expects RuiYi to file an investigational new drug application (IND) with the CFDA authorities within 18 to 26 months

received final approval from the FDA for its abbreviated new drug application for Zolmitriptan Tablets, 2.5 mg and 5 mg

Arbor Pharmaceuticals Inc., of Atlanta, said the FDA approved its new drug application for Nymalize (nimodipine) oral solution...DSC127 is in two U.S. Phase III trials in diabetic foot ulcers, and Derma Sciences plans to submit a new drug application to the FDA following their completion. (See BioWorld Today, Feb. 7, 2013

The injunction also requires Ranbaxy to review and verify data submitted in past drug applications to the FDA

Mirna filed its first investigational new drug application with the FDA for MRX34 earlier this year

Based on its SPA for the pivotal study, the Redwood City, Calif.-based firm "feels really good" about submitting a new drug application (NDA) to the FDA on the heels of the Phase III trial, Klaerner said

The injunction also requires Ranbaxy to review and verify data submitted in past drug applications to the FDA

Actavis Inc., of Parsippany, N.J., reported the FDA has accepted for filing its new drug application for a progestin-only transdermal contraceptive patch (Norethindrone Transdermal Delivery System) for use by women to prevent pregnancy...Janssen Research & Development LLC, of Raritan, N.J., a unit of Johnson & Johnson, said the FDA granted priority review to its new drug application for simeprevir (TMC435), an NS3/4A protease inhibitor for once-daily administration with pegylated interferon and

Dyax plans to file an investigational new drug application by the end of June and, pending acceptance by the FDA, will move into a Phase I study with healthy volunteers and then begin testing the drug in patients

The company expects to report top-line results from the current study in late 2013 or early 2014 and to file a new drug application with the FDA in 2014. (See BioWorld Today, March 20, 2013

drug application, to the Osaka, Japan-based big pharma

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

Pain Therapeutics submitted the initial new drug application (NDA) for Remoxy, an extended-release oral formulation of oxycodone for the relief of moderate to severe pain, in June 2008 and received a CRL in December 2008

Plandai Biotechnology Inc., of Seattle, said it formed Phyto Pharmacare Inc., a Delaware corporation to oversee all aspects of developing and marketing Phytofare extracts for pharmaceutical and drug applications

investigational new drug application in 2014 and begin Phase II studies for psoriasis and atopic dermatitis in the second half of 2014

Earlier this month, Alimera resubmitted the new drug application for Iluvien, which has a PDUFA date of Oct. 17

Andrew Robbins, vice president of commercial operations for Array, noted that Novartis is scheduled to commence the NRAS melanoma trial "momentarily," and its data would be filed as a registration study, so that the ovarian trial's results would be part of a supplemental new drug application, if all goes well

However, cancer drugs that filed for regulatory approval mostly succeeded, with 92 percent that submitted a new drug application or biologics license application gaining the FDA's endorsement

Arrowhead expects to submit an investigational new drug application this quarter, with dosing in healthy volunteers expected to start in the third quarter...Proceeds will be used to fund ongoing pre-investigational new drug application studies for lead compound NPT002 and to advance fusion proteins for treating neurodegenerative conditions, including Alzheimer's, Parkinson's and Huntington's diseases