The US Food and Drug Administration (FDA) has granted 510(k) clearance to Medical Modeling's Virtual Surgical Planning (VSP) system product line. The products, which utilize the company's VSP system technology, include VSP Orthognathics ...
Tags: FDA, VSP system product line, US, approval
Tensys Medical's new continuous, non-invasive hemodynamic patient monitoring system has obtained 510(k) clearance from the US Food and Drug Administration (FDA). The TL-300 system, a member of T-Line family, is designed for use in ...
Tags: Hemodynamic Patient Monitor, FDA Approval, TL-300 system
Halt Medical has obtained $15m finance from American Capital to support the commercialization of its Acessa system, designed for treating uterine fibroids. Using a slender Handpiece, the CE-marked system delivers radiofrequency energy to ...
Tags: Halt Medical, American Capital, commercialization, Acessa system
US-based medical firm Wartrol has released its Wartrol Warts Relief Treatment in a new packaging for online purchase. The firm said the new treatment is an FDA approved product, which uses 100% natural formula to remove genital warts ...
Tags: Wartrol, Wartrol Warts Relief Treatment, packaging, online purchase
Gilead Sciences, a biopharmaceutical company, has submitted a new drug application (NDA) to the FDA for HIV integrase inhibitor elvitegravir for the treatment-experienced patients. The company provided 96-week data from a pivotal Phase ...
The US Food and Drug Administration (FDA) has approved Perrigo's abbreviated new drug application (ANDA) for calcium acetate capsules. The generic equivalent of Phoslo Gelcaps are used to treat hyperphosphatemia in patients with end stage ...
Tags: FDA, Perrigo ANDA, calcium acetate capsules
The FDA has approved Clinigen Healthcare's supplemental new drug application (sNDA) for Foscavir (foscarnet sodium), a treatment for HIV/AIDS-related cytomegalovirus (CMV) infections and herpes. Hospira will distribute Foscavir to US ...
XenoPort has received a US patent for, prodrugs of methyl hydrogen fumarate, pharmaceutical compositions thereof, and methods of use. The patent is directed to composition and formulations of the XP23829 compound and another patent ...
Tags: XenoPort, US patent, covering composition
Aurobindo Pharma has secured approval from the US FDA to manufacture and market nafcillin for injection USP, packed in 1g and 2g bottles as well as nafcillin for injection USP 10g bottle pharmacy bulk package. Nafcillin, is a sterile ...
Tags: Aurobindo Pharma, market nafcillin, injection USP, pharmacy bulk package
Depomed's lawsuits against Watson Laboratories and Par Pharmaceutical in relation to Abbreviated New Drug Applications (ANDAs) for Gralise (gabapentin) have been dismissed. The company said that both the companies no longer sought ...
Tags: Depomed, Watson Laboratories, Par Pharmaceutical, lawsuit
Aegerion Pharmaceuticals' Juxtapid (lomitapide) capsules has received US FDA approval to be used as an adjunct to a low-fat diet and other lipid-lowering treatments. Juxtapid, which is a supplement to fat reduction treatments also ...
Tags: Juxtapid, US, FDA, capsules, treatments
AMAG Pharmaceuticals has submitted a supplemental new drug application (sNDA) for intravenous (IV) use of Feraheme injection, to FDA. The company is seeking approval for the label expansion of Feraheme to include all iron deficiency ...
Tags: Feraheme Injection, AMAG, SNDA
Bombay High Court in India has said that lactic acid used in the making of Parle Kaccha Mango Bite is safe for consumption. The verdict was given based on the regulations under the Food Safety and Standards Act 2006, reported the ...
Tags: Bombay High Court, India, lactic acid, food industry
Sunland’s peanut butter plant in New Mexico, which has been linked to a salmonella outbreak in the US, has received a FDA approval to recommence operations at the plant. The plant can re-operate after developing a sanitation plan ...
Tags: peanut butter plant, peanut butter, Sunland, FDA
The US FDA has approved the use of Genentech's Tamiflu (oseltamivir phosphate) for the treatment of Influenza in infants aged two weeks and more. Tamiflu works by blocking the ability of the virus to replicate in the body thereby ...