Drug Approvals News

Q-Med (STO:QMED) has obtained registration approval for Restylane® in China. An application for sales approval will be submitted shortly and it is estimated that sales of the product will begin at the end of the second quarter in 2009. "There is a large appetite for new things in China and great respect for products from the West.

BASi is proud to announce the awarding of the new European patent for their Culex® Automated In Vivo Sampling System. The patent is valid until 2019 and is effective in Germany, Denmark, France, UK and Sweden. The Culex Automated In Vivo Sampling System is designed to collect pharmacokinetic and pharmacodynamic (PK/PD) data during the course of drug metabolism experiments.

Ipsen (Paris:IPN) announced that the U.S. Food and Drug Administration (FDA) provided notification that the Prescription Drug User Fee Act (PDUFA) action date for Reloxin® (botulinum toxin of type A) Biologics License Application (BLA) in aesthetic indications (glabellar lines) has been extended to April 13, 2009. The FDA did not issue any specific request on the occasion of this extension.

ISPE, a global not-for-profit association of 25,000 pharmaceutical science and manufacturing professionals, has announced plans to host a live webinar on 13 January that will allow participants to interact with representatives of the US FDA and discuss critical process validation guidelines. The live Process Validation webinar will be held on 13 January 2009.

QuantRx Biomedical Corporation (OTCBB: QTXB), a broad-based diagnostic company focused on the development and commercialization of innovative diagnostic products, announced that the U.S. Food and Drug Administration (FDA) has granted the Company 510(k) clearance on its RapidSense drugs-of-abuse (DOA) Methamphetamine test.

arGentis Pharmaceuticals, LLC announced that the European Medicines Agency's (EMEA) Committee for Orphan Medicinal Products (COMP) adopted a positive opinion recommending the company's product candidate ARG201 (native type 1 bovine collagen) for the treatment of diffuse systemic sclerosis, also known as systemic scleroderma (SSc) for designation as an orphan medicinal product to the European Commi

David H. Fater, President and CEO of Vicor Technologies, Inc., announced that on December 29, 2008 Vicor Technologies received FDA 510(k) approval (K082709) to market its PD2i Analyzer, permitting immediate commercialization of the technology. Vicor Technologies, Inc.

The Myelodysplastic Syndromes (MDS) Foundation applauds the European Commission's approval of VIDAZA (azacitidine) as an important advance for MDS patients in Europe. Vidaza represents an entirely new approach to treating cancer- it works by epigenetics, that is it helps restore the normal function of genes that regulate cell growth and development.

Eli Lilly and Company (NYSE: LLY) announced that it received a complete response letter from the U.S. Food and Drug Administration (FDA) for olanzapine long-acting injection (LAI) for acute and maintenance treatment of schizophrenia in adults. Lilly is continuing to work with the agency on the new drug application (NDA).

Results of a new survey of 500 GPs, conducted by TNS Healthcare UK one year after the publication of the NICE health technology appraisal (HTA) on ezetimibe1, show 69% of GPs are familiar with the Guidance.