Mylan Pharmaceuticals, the subsidiary of Mylan, has introduced Fenofibrate tablets, 48 mg and 145 mg. The company has received the final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application ...
Tags: Mylan, Generic Version
Eco-Cuisine, an establishment based in Boulder, Colorado, US, is recalling all lots of baking mix products as they have the potential to be contaminated with Salmonella. The recall was initiated as a result of notification by CHS Foods ...
Tags: Eco-Cuisine, Baking Mix Products
Health Canada has approved Life Technologies' applied biosystems 3500 Dx /3500 xL Dx Genetic Analyzers CS2 for diagnostic use. The 3500xL Dx is an automated 24 capillary Sanger Sequencer instrument while the 3500 Dx is an eight capillary ...
Tags: Health Canada, Genetic Analyzers
EnteroMedics is planning to submit the pre-PMA (Premarket Approval) application for its Maestro Rechargeable System's VBLOC vagal blocking therapy, based on the ReCharge Pivotal Trial, in the second quarter of 2013. The decision follows ...
Tags: Enteromedics, VBLOC Therapy
Acorda Therapeutics has obtained additional US patent for ampyra covering a range of dosage strengths. Ampyra, referred to as fampridine in some countries outside the US, is indicated for the treatment to improve walking in patients with ...
Switzerland-based specialty chemicals firm Clariant has unveiled a new perfluorooctanoic acid (PFOA)-free grease resistant additive, 'Cartaguard KHI' for safer food papers and board. The additive supports the trend toward eco-friendly ...
Tags: Clariant, Food Packaging Papers
The US Food and Drug Administration (FDA) has approved Thoratec's HeartMate II Pocket Controller, the safe face of the HeartMate II LVAD System. The Pocket Controller is lighter and compact than the previous LVAD system controllers, and ...
EXP Pharmaceutical Services, a US-based healthcare services provider, has entered into a strategic partnership with AnewMed, operating an FDA-Registered Establishment for the renewal of medical devices with expired packaging. The ...
The US FDA has approved Algeta's Xofigo (radium-223 dichloride) injection for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. Xofigo is the first ...
Swiss speciality chemicals company Clariant has introduced a new perfluorooctanoic acid (PFOA)-free grease resistant additive, 'Cartaguard KHI' for safer food papers and board. The additive makes paper grease resistant without releasing ...
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
In the year from September 8, 2011, to September 7, 2012, listeria monocytogenes in fresh cut onions, salmonella Braenderup in imported mangoes and undeclared milk in a nationally distributed snack bar sparked the most reports. A total of ...
Tags: FDA, Food Incident Update
With an abundance of "All Natural" claims on foods and beverages but no defined standard, The Food Journal has examined the impact of "All Natural" to manufacturers, government agencies, brand managers, retailers and consumers and if the ...
Tags: Consumer Skepticism, Label, Packaging
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
Roche Group member Genentech and Astellas Pharma US announced that the US Food and Drug Administration (FDA) has cleared Tarceva (erlotinib). The tablets are used for the initial treatment of people with metastatic non-small cell lung ...
Tags: FDA, Tarceva Tablets, Astellas Pharma