Posts Tagged ‘submits’

AVANIR Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced the submission of its Complete Response to the October 2006 Approvable Letter issued by the U.S. Food and Drug Administration (FDA) for Zenvia™ (dextromethorphan/quinidine) for the treatment of pseudobulbar affect (PBA). AVANIR expects the FDA to classify the response as a Class 2 resubmission1, which would result in an expected review period of 180 days and potential approval ... Full story

Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage pharmaceutical company commercializing potential best in class oncology and CNS therapeutics, announced that it has submitted a Phase IIb protocol to the FDA for ZoraxelTM for the treatment of erectile dysfunction (ED). "The progression of Zoraxel's clinical program is very encouraging," said Rexahn Chief Executive Officer, Dr. Chang Ahn. "We believe that the future ... Full story

ImmuneRegen BioSciences Inc.®, a wholly owned subsidiary of IR Biosciences Holdings Inc. (OTCBB: IRBS), today announced the submission of an application for Orphan Drug Product Designation for the company's lead compound, Homspera®, for the application of treating Idiopathic Pulmonary Fibrosis, a deadly pulmonary disease with no FDA-approved treatments. The United States Orphan Drug Act was created in 1983 to provide incentives for companies to ... Full story

Cleveland BioLabs, Inc. (NASDAQ: CBLI) announced that it has submitted a response to the Request for Proposal (RFP) issued by The Department of Defense (DoD) for the advanced development, Food and Drug Administration (FDA) approval/licensure and delivery of Medical Radiation Countermeasure (MRC). In a statement to the press, Michael Fonstein, Ph.D... Go ... Full story

Biodel, Inc. (Nasdaq: BIOD) announced today that it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration for clearance to market VIAject® as a treatment for diabetes. VIAject® is Biodel's proprietary formulation of recombinant human insulin that is designed to be absorbed into the blood faster than currently marketed rapid-acting insulin analogs. It is Biodel's most advanced product candidate and ... Full story

Santarus, Inc. (NASDAQ:SNTS), a specialty biopharmaceutical company, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) requesting approval to begin a Phase III clinical program evaluating rifamycin SV MMX® in patients with travelers' diarrhea... Go to Source Full story

Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for lorcaserin, Arena's internally discovered and developed drug candidate for weight management, including weight loss and maintenance of weight loss. The submission is based on an extensive data package from lorcaserin's clinical development program that includes 18 clinical trials totaling 8,576 patients. ... Full story

Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for JZP-6 (sodium oxybate oral solution) for the treatment of fibromyalgia. The submission is based on a comprehensive clinical development program for JZP-6, including results from two Phase III clinical trials. In both trials, sodium oxybate significantly decreased pain and fatigue as well as ... Full story

The Academy has submitted comments on a proposed rule from the Centers for Medicare and Medicaid Services (CMS) that would make technical and policy changes to the Medicare Part D drug benefit. CMS's proposed rule, issued Oct. 22, 2009, clarifies program participation requirements, specifies changes to strengthen beneficiary protections, requires plan offerings to include meaningful differences, updates plan payment rules and processes, and implements new ... Full story

Javelin Pharmaceuticals, Inc. (NYSE Amex: JAV), a leading developer and marketer of specialty pharmaceutical products for pain management, today announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its investigational product candidate, Dyloject™ (diclofenac sodium) Injection, for the management of acute moderate-to-severe pain in adults. If approved, Dyloject will be the first IV non-steroidal anti-inflammatory ... Full story