Ascension Orthopedics, a developer of PyroCarbon orthopedic devices, has received FDA approval to market the Titan modular total shoulder system. According to the company, the Titan modular total shoulder system offers a bone-preserving option for patients needing total or hemi shoulder arthroplasty.
CSL Behring announced that the U.S. Food and Drug Administration has approved a supplemental Biologics License Application to extend the shelf life of Hizentra, Immune Globulin Subcutaneous, 20% Liquid, from 18 months to 24 months. Stabilized with L-proline, a naturally occurring amino acid, Hizentra can be stored at room temperature for up to 24
GlaxoSmithKline and Human Genome Sciences announce FDA priority review designation for Benlysta belimumab as a potential treatment for systemic lupus erythematosus.
Human Genome Sciences and GlaxoSmithKline Announce FDA Priority Review Designation for BENLYSTA belimumab as a Potential Treatment for Systemic Lupus Erythematosus. Human Genome Sciences, Inc. and GlaxoSmithKline PLC announced that the U.S. Food and Drug Administration has granted a priority review designation to BENLYSTA as a potential treatme
Abbott, a healthcare company engaged in the discovery, development, manufacture and marketing of pharmaceuticals and medical products, has received approval from the US Food and Drug Administration, or FDA, to market the Abbott RealTime HBV assay for measuring viral load or the amount of hepatitis B virus, or HBV, in a patient's blood.
Actavis, a US-based manufacturing and marketing unit of generics firm Actavis Group, has received approval from the US Food and Drug Administration, or FDA, to market Atomoxetine HCl capsules for the treatment of attention deficit/hyperactivity disorder, or ADHD. Actavis intends to market Atomoxetine HCl in 10mg, 18mg, 25mg, 40mg, 60mg, 80mg and 10
AUSTIN, Texas, Sept. 2 Ascension Orthopedics, Inc., the world leader in PyroCarbon orthopedic devices, announces FDA approval to market the TITAN Modular Total Shoulder System.
September 2, 2010 Unilife Corp. said that its Unitract Tuberculin Syringe has received 510 market clearance from the U.S. Food and Drug Administration. The Unitract range is designed to allow operators to control the speed of passive needle retraction directly from the patient's body into the barrel of the syringe where it is locked in place.
InfraReDx, a medical device company, has received 510k clearance from the US Food and Drug Administration, or FDA, to market the LipiScan IVUS coronary imaging system.
Pyng Medical, a Canada-based medical device company, has received 510 clearance from the US Food and Drug Administration, or FDA, to market the FASTx sternal intraosseous device.
SQI Diagnostics Inc., a medical systems automation company focused on evolving laboratory-based biomarker testing, announced today that the United States Food and Drug Administration has received the Company's 510 submission seeking marketing clearance in the U.S. for SQI's IgX PLEX Celiac Assay and automated SQiDworks Diagnostics Platform.
Unilife, a US-based medical device company, has announced that its Unitract Tuberculin, or TB, syringe has received 510k market clearance from the US Food and Drug Administration, or FDA. According to the company, the Unitract TB syringe is a variant of the Unitract 1ml insulin syringe for which Unilife secured FDA clearance earlier in 2010.
DES PLAINES, Ill., Sept. 1 Abbott announced today it has received approval from the U.S. Food and Drug Administration to market the Abbott RealTime HBV assay for measuring viral load or the amount of hepatitis B virus in a patient's blood.
MORRISTOWN, N.J., Sept. 1 /PRNewswire/ Actavis has received approval from the U.S. Food & Drug Administration to market Atomoxetine HCl capsules for the treatment of attention deficit/hyperactivity disorder. Actavis intends to market Atomoxetine HCl in 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg strengths.
Allergan, a healthcare company, has announced that the FDA has approved Lumigan 0.01% as a first-line therapy indicated for the reduction of elevated intraocular pressure, or IOP, in patients with open-angle glaucoma or ocular hypertension.
The U.S. Food and Drug Administration today approved ella tablets for emergency contraception. ella is a progesterone agonist/antagonist whose likely main effect is to inhibit or delay ovulation. An FDA Advisory Committee for Reproductive Health Drugs discussed ella in June, 2010. The safety and efficacy of ella were demonstrated in two Phase III c
BURLINGTON, Mass., Sept. 1 InfraReDx, Inc., a medical device company developing intelligent cardiovascular diagnostic imaging technologies, today announced that it has received 510 clearance from the United States Food and Drug Administration to market the LipiScan IVUS Coronary Imaging System.
Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration has accepted, for filing and review, the Biologics License Application for ipilimumab for the treatment of adult patients with advanced melanoma who have been previously treated. Ipilimumab is Bristol-Myers Squibb's second drug under priority review by the FDA this ye
Drug delivery products company pSivida Corp stated on Tuesday that the US Food and Drug Administration has granted Priority Review status for the company's New Drug Application filed for Iluvien for the treatment diabetic macular edema. The notification was granted to the company's licensee, Alimera Sciences.
09/01/10 Pyng Medical Corp. announces today that it has received 510 clearance from the US FDA to market the FASTx? Sternal Intraosseous Device. The FASTx? Sternal Intraosseous Device is indicated for use in establishing a sternal intraosseous access route in adult and adolescent patients that require vascular administration of drugs or fluids
Quidel, a provider of diagnostic testing solutions, has received 510 clearance from the FDA for the sale of Quidel's RapidVue hCG test, a lateral flow pregnancy immunoassay for the qualitative detection of human chorionic gonadotropin, or hCG. The three-minute RapidVue hCG test is CLIA-waived for use with urine samples.
MonoSol Rx, a specialty pharmaceutical company, has announced that its partner, Reckitt Benckiser Pharmaceuticals, a wholly-owned subsidiary of Reckitt Benckiser Group, has received approval from the FDA to market Suboxone sublingual film for the treatment of opioid dependence.
Sun Pharmaceutical Industries, a speciality pharmaceutical company, has announced that the FDA has granted its subsidiary an approval for its abbreviated new drug application to market a generic version of Strattera, atomoxetine hydrochloride capsules.
LEWISBERRY, Pa., Sept. 1 Unilife Corporation, today announced that its Unitract Tuberculin Syringe has received 510 market clearance from the U.S. Food and Drug Administration. . The Unitract TB syringe is a variant of the Unitract 1mL Insulin Syringe for which Unilife secured FDA clearance earlier this year.
