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Last updated on April 19, 2014 at 8:29 EDT

Latest US Food and Drug Administration Stories

2010-02-24 07:00:00

SAN DIEGO, Feb. 24, 2010 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced today that its New Drug Application (NDA) for lorcaserin, Arena's internally discovered and developed drug candidate for weight management, including weight loss and maintenance of weight loss, has been accepted for filing by the US Food and Drug Administration (FDA). Arena submitted the lorcaserin NDA on December 22, 2009, and expects to learn the Prescription Drug User Fee Act (PDUFA)...

2010-02-23 07:30:00

BEDFORD, Mass., Feb. 23 /PRNewswire/ -- Instrumentation Laboratory (IL) today announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its HemosIL D-Dimer HS 500 assay. Additionally, the Company received a license from Health Canada for the product. The Company will now initiate commercialization of HemosIL D-Dimer HS 500 in North America, with their distribution partner, Beckman Coulter, Inc. In April 2009, the assay was previously released in...

2010-02-18 16:54:00

RESEARCH TRIANGLE PARK, N.C., Feb. 18 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) is reviewing label changes proposed today by the US Food and Drug Administration (FDA) for asthma medications containing long-acting beta-agonists (LABAs), such as GSK's Advair (salmeterol / fluticasone propionate). GSK and makers of the other affected medicines containing LABAs have 30 days to agree with the proposed changes or state why they are not warranted. "We will work with FDA to ensure...

2010-01-28 08:00:00

CARLSBAD, Calif., Jan. 28 /PRNewswire/ -- Aubrey Inc., an advanced wound care company, announced it has received clearance from the US Food and Drug Administration (FDA) to market the AWBAT Plus product line in the United States. This represents a significant milestone for the company as it is the second product line to be launched in the company's two year history. The initial product line, AWBAT, continues to gain adoption in burn centers throughout the US and is planned for launch in...

2009-12-22 07:00:00

SAN DIEGO, Dec. 22, 2009 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced today 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...

2009-12-14 15:05:00

MOUNTAIN VIEW, Calif., Dec. 14 /PRNewswire-FirstCall/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) today announced that it has submitted its New Drug Application (NDA) for Staccato® loxapine (AZ-004) to the US Food and Drug Administration (FDA). AZ-004 is an inhalation product candidate being developed for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder. The IND for Staccato loxapine was filed with the FDA in August 2005. "AZ-004...

2009-12-04 06:00:00

WILMINGTON, Del., Dec. 4 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE: AZN) today announced that the US Food and Drug Administration (FDA) has approved once-daily SEROQUEL XR® (quetiapine fumarate) Extended Release Tablets as adjunctive (add-on) treatment to antidepressants in adults with Major Depressive Disorder (MDD). SEROQUEL XR is the only medication in its class approved by the FDA to treat both major depressive disorder as adjunctive therapy and acute depressive...

2009-11-30 08:06:00

ROCKLAND, Mass., Nov. 30 /PRNewswire/ -- EMD Serono, an affiliate of Merck KGaA, Darmstadt, Germany, announced today that it received a refuse to file letter from the US Food and Drug Administration (FDA) on the New Drug Application (NDA) for Cladribine Tablets, EMD Serono's proprietary investigational oral formulation of cladribine, as a therapy for relapsing forms of multiple sclerosis (MS). "The company will work closely with the FDA to fully understand FDA's concerns and define a...

2009-11-24 15:01:00

SAN DIEGO, Nov. 24 /PRNewswire-FirstCall/ -- Gen-Probe Incorporated (Nasdaq: GPRO) announced today that the US Food and Drug Administration (FDA) has cleared for marketing Prodesse's ProParaflu+(TM) assay, a molecular test that detects and differentiates parainfluenza 1, 2 and 3 viruses, which cause lower respiratory tract infections. Prodesse is a wholly-owned subsidiary of Gen-Probe, a global leader in molecular diagnostics. "FDA clearance of our 510(k) application for ProParaflu+...

2009-10-29 06:00:00

SAN DIEGO, Oct. 29 /PRNewswire-FirstCall/ -- Gen-Probe Incorporated (Nasdaq: GPRO) today announced that the US Food and Drug Administration (FDA) has granted an EUA (emergency use authorization) for its test, the Prodesse ProFlu-ST(TM), to be used in CLIA high complexity laboratories for the diagnosis of 2009 H1N1 influenza virus infection, aided by an algorithm that relies on seasonal influenza A/H1 virus and seasonal influenza A/H3 virus results, from a single sample in individuals who...