Medical Animation Drug Approval

FDA Approves New Drug To Treat Severe Form Of Epilepsy
The U.S. Food and Drug Administration has approved a new drug, Banzel (rufinamide), for use as an adjunctive (add-on) treatment for seizures associated with Lennox-Gastaut syndrome. "This approval offers another treatment option for patients who suffer from these debilitating, severe seizures," said Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research.

FDA Acts To Avoid Shortage And Strengthen The Safety Of Sucraid
The U.S. Food and Drug Administration today issued an expedited approval of a supplemental application that allows for changes in the manufacturing of Sucraid (sacrosidase) Oral Solution. The approval will prevent a product shortage by allowing the sole manufacturer of the drug, QOL Medical, to obtain Sucraid's active ingredient from a different manufacturer.

FDA 510(k) Clinical Trial Progress For AppyScore, World's First Blood-Based Diagnostic Test For Human Appendicitis
AspenBio Pharma, Inc. (NASDAQ: APPY), an emerging bio-pharmaceutical company dedicated to the development of novel drugs and diagnostics for humans and animals, reported the enrollment level in the ongoing FDA 510(k) clinical trial for AppyScore(TM), the world's first blood-based diagnostic test for human appendicitis exceeds 700 patients.

European Agency For The Evaluation Of Medicinal Products Recommends Suspension Of Marketing Authorisation For IONSYS(R)
Janssen-Cilag International NV announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has recommended suspension of the marketing authorisation for IONSYS(R) (fentanyl iontophoretic transdermal system), indicated for the management of acute moderate to severe post-operative pain for use in a hospital setting only.

Duska Therapeutics Applies For Phase 3 Special Protocol Assessment
Duska Therapeutics, Inc., (OTC Bulletin Board: DSKA), announced that it has submitted its pivotal Phase 3 ATPace clinical trial protocol for review under a Special Protocol Assessment (SPA) procedure with the U.S. Food and Drug Administration (FDA). Subject to securing an agreement with the FDA, Duska intends to initiate a single, prospective, double-blind, placebo-controlled and randomized Phase 3 clinical trial with its lead product ATPace.

Ortho Biotech Announces NDA Submission For Trabectedin For The Treatment Of Relapsed Ovarian Cancer
Ortho Biotech Products, L.P. announced the submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for trabectedin when administered in combination with DOXIL(R) (doxorubicin HCI liposome injection)for the treatment of women with relapsed ovarian cancer (ROC). If approved, trabectedin combined with DOXIL will provide a new, non-platinum treatment option for these patients in the United States.

Relapsed Ovarian Cancer - Submitted New Drug Application To FDA For Trabectedin
PharmaMar announced today that Ortho Biotech Products, L.P. has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for trabectedin when administered in combination with DOXIL® (pegylated liposomal doxorubicin) for the treatment of women with relapsed ovarian cancer (ROC). If approved, trabectedin combined with DOXIL® will provide a new, non-platinum treatment option for these patients in the United States.

Pfizer Drops Application To Switch Viagra 50mg To Non-Prescription Status In Europe
Pfizer announced today that it has withdrawn its application to switch the legal status of the 50 mg tablet strength of Viagra from 'prescription only' to 'non-prescription' in the European Union (EU). Viagra is a well established oral medication for the treatment of erectile dysfunction (ED) and all current doses of Viagra will continue to be available to patients by prescription from their doctor.

FDA Advisory Committee Provides Opinion On Oritavancin For The Treatment Of Complicated Skin And Skin Structure Infections
Targanta Therapeutics Corporation (Nasdaq: TARG) today announced that oritavancin, the Company's investigational antibiotic therapy for the treatment of complicated skin and skin structure infections (cSSSI) caused by gram-positive pathogens, including methicillin resistant Staphylococcus aureus (MRSA), received a mixed review from the United States Food and Drug Administration's (FDA) Anti-Infective Drugs Advisory Committee.

SyntheMed Announces FDA Clearance Of SinusShield(TM)
SyntheMed, Inc. (OTC Bulletin Board: SYMD) announced that it has received FDA 510(k) clearance to market SinusShield(TM), a bioresorbable membrane intended to prevent post-operative adhesions in nasal and sinus surgical procedures. There are approximately two million nasal and sinus procedures performed annually in the United States. Robert P.

FDA Approves Lumen Biomedical's FiberNet Embolic Protection System For Carotid Artery Stenting
Lumen Biomedical, Inc. (Plymouth, MN) announced today that the U.S. Food and Drug Administration (FDA) has cleared its FiberNet® Embolic Protection System (EPS) for the treatment of patients receiving endovascular intervention for carotid artery disease. The approval follows the recent release of the EPIC Clinical Study data demonstrating the lowest stroke rates of any filter currently available on the US market.

APR Applied Pharma Research And Fidia Farmaceutici Receive IND Approval From FDA For A New NSAID Matrix Patch Product
Applied Pharma Research sa (APR), and Fidia Farmaceutici SpA (Fidia) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for the development of a 140mg Diclofenac Sodium Matrix Patch for the topical treatment of acute pain due to minor strains, sprains and contusions.

FDA Scientists Allege Coercion In Medical Device Approval Process, House Panel Investigates
The House Energy and Commerce Committee on Monday launched an investigation into allegations by at least eight FDA scientists that agency managers coerced those in the medical device division into approving products despite serious safety and effectiveness concerns, CongressDaily reports (Edney, CongressDaily, 11/18). Committee Chair John Dingell (D-Mich.

HHS Opens Offices Of The Food And Drug Administration (FDA) In China
As part of an ongoing strategy to continually improve import safeguards to meet the changing demands of a global economy, the U.S. Department of Health and Human Services (HHS) is this week officially opening offices of its Food and Drug Administration (FDA) in Beijing, Guangzhou and Shangai in the People's Republic of China. HHS Secretary Mike Leavitt and FDA Commissioner Andrew von Eschenbach, M.D.

Delcath Systems Granted Orphan-Drug Designations For Cutaneous And Ocular Melanoma
Delcath Systems, Inc. (Nasdaq: DCTH), a medical technology company testing its proprietary liver cancer treatment for melanoma metastatic to the liver, announced that the United States Food and Drug Administration ("FDA") granted to Delcath two orphan-drug applications for the drug melphalan. Delcath was granted designations of the drug melphalan for the treatment of patients with cutaneous as well as ocular melanoma.