Dental lasers distributor Biolase has announced that the US Food and Drug Administration (FDA) has cleared NewTom Biolase VG3 digital panoramic, cephalometric, and tomographic extra-oral X-ray system. The VG3 is a complement to the ...
Tags: FDA, Panoramic Oral X-Ray System
The US FDA has approved Mylan Pharmaceuticals' abbreviated new drug application (ANDA) for Zolmitriptan tablets, 2.5mg and 5mg. The generic equivalent of IPR Pharmaceuticals' Zomig tablets is indicated for the acute treatment of migraine ...
Tags: FDA, Pharmaceuticals
The US FDA has approved Xofigo (radium Ra 223 dichloride) for the treatment of symptomatic late-stage (metastatic) castration-resistant prostate cancer spread to bones but not to other organs in men. The therapy is indicated for men whose ...
Sorin Group, a Netherlands-based company, has received US FDA approval for the launch the Smartview remote monitoring solution for patients with implanted cardiac rhythm management (CRM) devices. Using the secure SMARTVIEW remote ...
Tags: Sorin Group, Monitoring Solution
The US FDA has expanded the indication for the Medicines Company's Recothrom for use in children greater than or equal to one month of age. The recombinant topical thrombin is indicated to aid hemostasis whenever oozing blood and minor ...
Warner Chilcott has announced US FDA approval of norethindrone acetate and ethinyl estradiol chewable tablets and ferrous fumarate tablets, new oral contraceptive. The company expects to make the product available in early August 2013. ...
Masimo (MASI) has received the US FDA 510(k) clearance for its rainbow Acoustic Monitoring sensor, RAS-125c Acoustic Respiration Cloth Sensor for monitoring acoustic respiration rate (RRa) in pediatric patients. The RAS-125c Acoustic ...
Tags: Medicine, Monitoring Sensor
GlaxoSmithKline (GSK) has submitted a new drug application (NDA) to the US FDA for umeclidinium bromide (UMEC) monotherapy 62.5mcg to treat chronic obstructive pulmonary disease (COPD). The investigational once-daily UMEC, administered ...
Tags: GlaxoSmithKline, FDA Approval, chronic obstructive pulmonary disease
Omeros has filed an orphan drug application with the US FDA for OMS721, used to treat atypical hemolytic uremic syndrome (aHUS). OMS721 works by blocking the lectin pathway of the complement system while leaving intact the classical ...
Tags: Omeros, Orphan Drug, Medicine
The US FDA has granted final approval for Mylan Pharmaceuticals' abbreviated new drug application (ANDA) for Acyclovir Ointment USP, 5%. Acyclovir Ointment is the generic equivalent to Zovirax Ointment from Valeant International. Mylan ...
Tags: FDA, Acyclovir Ointment, Medicine
The US FDA has approved Teva Pharmaceutical Industries' new drug application (NDA) for Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) tablets as oral contraceptives. Quartette, designed as next generation of extended ...
Tags: Health, Medicine, oral contraceptives
Janssen Research & Development is seeking US FDA approval for the use of Simeprevir (TMC435) in combination with pegylated interferon and ribavirin to treat genotype 1 chronic hepatitis C in adults. The company submitted a new drug ...
Tags: Health, Medicine, pegylated interferon
The US FDA has accepted Merck's biologics license application (BLA) for an investigational allergy immunotherapy tablet (AIT), Timothy grass pollen (Phleum pratense). The application includes safety and efficacy data of the ...
Tags: FDA, Merck Bla, Allergy Immunotherapy Tablet
The US FDA has cleared Eisai's ACIPHEX Sprinkle (rabeprazole sodium) as 12-week gastroesophageal reflux disease (GERD) therapy for use in children between one to eleven years age. The approval was based on positive data from multicenter, ...
Tags: FDA, Disease Therapy for Children, Medicine
Quidel and Life Technologies have received 510(k) approval from US FDA to market the Quidel Molecular Direct C. difficile Assay with Life Technologies' QuantStudio Dx and 7500 Fast Dx Applied Biosystems Real-Time PCR Instruments. The ...
Tags: Quidel, Life Technologies, FDA Approval