Famy Care has won final FDA approval for abbreviated new drug application (ANDA) of Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15mg/0.03mg, generic equivalent to Teva Branded Pharmaceutical Products' Nordette 28 tablets. Mylan ...
Tags: Medicine
EMD Serono, a subsidiary of Merck, and Pfizer have announced the FDA approval of Rebif Rebidose (interferon beta-1a) for the treatment of relapsing forms of multiple sclerosis (MS). Rebif Rebidose was designed as single-use auto-injector ...
The US Food and Drug Administration (FDA) has granted 510(k) approval to Alphatec Holdings' new products, Pegasus and ILLICO FS Facet Fixation systems. Pegasus, an anchored anterior cervical interbody device, offers single-step deployment ...
Tags: MIS Systems, Alphatec, FDA Approval, New Anterior Cervical Interbody
Digital Mass Flow Controllers (MFC’s), as typically used in the semiconductor, chemical processing, food and pharmaceutical industries, are designed to both measure and control the flow of various gases and liquids. Applications also ...
Tags: Digital Mass Flow Controller, chemical processing, gas, liquid
Abbott has obtained regulatory approval for its XIENCE Xpedition Everolimus Eluting Coronary Stent system,designed for improving coronary artery luminal diameter in patients with symptomatic heart disease due to de novo native coronary ...
Tags: Abbott, FDA, Drug Eluting System, XIENCE, symptomatic heart disease
The US Food and Drug Administration (FDA) has cleared Soft Tissue Regeneration's biodegradable scaffold for use in soft tissue augmentation and rotator cuff repair. The STR GRAFT scaffold, a patch, can be draped over the tendon, that sits ...
Tags: FDA, Soft Tissue Regeneration's, STR GRAFT scaffold, Medicine
Dune Medical Devices' MarginProbe system, designed for the detection of breast cancer, has obtained premarket approval (PMA) from the US Food and Drug Administration (FDA). The system is an intra-operative tissue assessment tool which ...
Tags: Dune Medical, FDA Approval, Breast Cancer Detection Device, Medicine
Delifish is voluntarily recalling cold smoked salmon products due to Listeria monocytogenes contamination, according to the US Food and Drug Administration (FDA). The products subject to recall, from lots 249 through 291, were ...
Tags: Delifish, recall, cold smoked salmon products, food safety
The US Food and Drug Administration (FDA) has approved Mylan Pharmaceuticals' abbreviated new drug applications (ANDA) for the generic equivalents to Merck's Maxalt MLT tablets and Maxalt tablets. Rizatriptan Benzoate orally ...
Tags: US, FDA, Mylan Pharmaceuticals, ANDA, Maxalt MLT tablets, Maxalt tablets
US FDA has approved Watson Pharmaceuticals' abbreviated new drug application (ANDA) for Oxycodone and Acetaminophen tablets, USP 7.5 mg/500 mg and 10 mg/650 mg. The tablets are the generic equivalent to Endo Pharmaceuticals' Percocet ...
Tags: US FDA, ANDA, Watson Pharmaceuticals, Oxycodone and Acetaminophen tablets
Bristol-Myers Squibb and Pfizer have announced the US FDA's approval for Eliquis (apixaban), used to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. In 2007, Pfizer and Bristol-Myers ...
Tags: US, FDA, Eliquis, patients, nonvalvular atrial fibrillation
Janssen Therapeutics has obtained accelerated approval from FDA for Sirturo (bedaquiline) tablets as part of combination therapy to treat adult patients with pulmonary multi-drug resistant tuberculosis (MDR-TB). The surrogate endpoint of ...
Tags: Janssen Therapeutics, accelerated approval, FDA, Sirturo tablets
Mylan's subsidiary Mylan Pharmaceuticals has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Phenytoin Chewable Tablets USP, 50 mg. Phenytoin is the generic ...
Tags: Mylan, Mylan Pharmaceuticals, US, FDA, ANDA, Phenytoin Chewable Tablets
US-based Bel-Ray has received NSF-H1 approval for No-Tox Food Grade Dry PTFE Spray used in 'clean industry' applications. The new multi-purpose, dry-film lubricant meets FDA requirements for incidental food contact and has been seen as ...
Tags: Bel Ray, Food Grade Dry PTFE Spray, food contact, food industry
The US FDA has approved Abbreviated New Drug Application (ANDA) for Breckenridge Pharmaceutical's rizatriptan benzoate tablets. Following the ANDA approval, the company has also annonunced the immediate launch of the tablets. ...
Tags: US FDA, ANDA, Breckenridge Pharmaceutical, rizatriptan benzoate tablets