As part of the transaction, Eisai transferred the new drug application for Targretin to Valeant, which assumed responsibility for pursuing the product's regulatory approval in the U.S. Eisai retained its rights to Targretin outside the U.S

Chelsea Therapeutics International Ltd., of Charlotte, N.C., said the director of the FDA's Office of New Drugs provided written guidance that Study 306B has the potential to serve as the basis for a resubmission of its new drug application (NDA) for Northera (droxidopa) in symptomatic neurogenic orthostatic hypotension (NOH

Algeta ASA, of Oslo, Norway, said that its partner Bayer AG, of Leverkusen, Germany, has received notification that the New Drug Application (NDA) for the investigational compound Radium Ra 223 Dichloride (radium-223) has been accepted for filing and granted priority review by the FDA

The FDA accepted for review a new drug application for lixisenatide, the once-daily glucagon-like peptide-1 (GLP-1) receptor agonist Zealand Pharma A/S has developed in partnership with Sanofi SA, paving the way for a possible U.S

Zealand Pharma A/S, of Copenhagen, Denmark, said partner Sanofi SA, of Paris, reported that the FDA accepted for review a new drug application for lixisenatide, a once-daily prandial glucagon-like peptide-1 receptor agonist, for the treatment of adults with Type II diabetes mellitis

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

If all goes well Covagen plans to file an investigational new drug application by the end of this year

The company plans to submit an investigational new drug application in 2014 for M923 and may generate a license or milestone payment for M511 and M834 next year

It also had received 13 investigational new drug applications for biosimilar development programs

The institute's funding is designed to support preclinical dosing and toxicology studies, with a goal of filing an investigational new drug application by the fourth quarter

United Therapeutics Corp., of Silver Spring, Md., said the FDA acknowledged the resubmission of its new drug application (NDA) for treprostinil diolamine (oral treprostinil) in pulmonary arterial hypertension

Based on available information, Actavis said it may be a "first applicant" to file an abbreviated new drug application (ANDA) for generic Exalgo in the 32-mg dosage strength and may be entitled to 180 days of generic market exclusivity if the ANDA is approved...Teva Pharmaceutical Industries Ltd., of Jerusalem, said the FDA approved its abbreviated new drug application for the generic version of Dublin, Ireland-based Shire plc's Adderall XR in 5-mg, 10-mg, 15-mg, 20-mg, 25-mg and 30-mg dosage

Of the 199 approved REMS, 37 percent were required preapproval, due to information in the drug applications

AVEO reported $19.3 million in collaboration revenue for 2012, made up primarily by a $15 million milestone payment from Astellas upon acceptance of AVEO's new drug application filing

Algeta ASA, of Oslo, Norway, said that its partner Bayer AG, of Leverkusen, Germany, has received notification that the New Drug Application (NDA) for the investigational compound Radium Ra 223 Dichloride (radium-223) has been accepted for filing and granted priority review by the FDA

Bayer HealthCare Inc., of Wayne, N.J., said the new drug application for the oncology compound radium Ra 223 dichloride has been accepted for filing and granted priority review by the FDA for the treatment of castration-resistant prostate cancer patients with bone metastases...Breckenridge launched its abbreviated new drug application (ANDA) prior to patent expiration pursuant to a settlement of patent litigation with Osaka, Japan-based Takeda Pharmaceutical Co

Addex Therapeutics SA, of Geneva, will focus its resources in its clinical rare disease pipeline, advancing current clinical and pre-investigational new drug application programs that are amenable to orphan drug designation in major markets, including the U.S., Europe and Japan

Advanced Cell Technology received FDA approval for an investigational new drug application for a Phase I/II study of its retinal pigment epithelial cells derived from human embryonic stem cells for myopic macular degeneration

Novo Nordisk A/S, of Bagsvaerd, Denmark, received a complete response letter (CRL) from the FDA on its new drug applications (NDA) for Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart) requesting additional cardiovascular data from a dedicated cardiovascular outcomes trial