Medical Product Guide» Company news

Solta Medical Announces FDA 510(k) Clearance Of Fraxel Re:store Dual Laser System For The Treatment Of Actinic Keratosis

Jim Marino — Fri, 24 Sep 2010 15:03:50 +0000

Solta Medical, Inc. has announced it has received FDA 510(k) clearance of its Fraxel re:store®Dual for the treatment of actinic keratosis (AKs). The Fraxel re:store Dual system takes the industry leading fractional laser technology to the next level by adding a novel 1927 nm wavelength, the first ever application of a Thulium laser in the aesthetics market. The Fraxel re:store Dual treatment provides superior results for the removal of AKs.

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RSB Spine, LLC, Announces Additional FDA Clearance For The InterPlate(R) L-Ti

Jim Marino — Tue, 14 Sep 2010 14:48:07 +0000

RSB Spine, LLC, announced that the InterPlate® L-Ti has been cleared for an additional product code (KWQ). The L-Ti was previously cleared as an interbody fusion device. RSB Spine Officers are excited about this new clearance. Because of the company’s Bridging Flush Fit™ design, they have always been of the opinion that the InterPlate L-Ti can function as an interbody fusion device and/or anterior lumbar plate. The new product code also simplifies coding for surgeons.

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Kalispell Regional Medical Center To Implement The SurgiCount Safety-Sponge(R) System

Jim Marino — Tue, 14 Sep 2010 14:41:51 +0000

SurgiCount Medical has announced that it has signed a contract with Kalispell Regional Medical Center to implement the SurgiCount Safety-Sponge® System, a proven solution to prevent one of the most common surgical errors, retained surgical sponges. The first hospital in the State of Montana to adopt the SurgiCount solution, Kalispell Regional Medical Center joins a prestigious list of over 50 user hospitals including 5 of U.S. News and World Report’s 2010-2011 Honor Roll Hospitals.

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Lorcaserin To Get FDA Approval

Jim Marino — Fri, 16 Jul 2010 09:14:32 +0000

A new diet pill, Lorcaserin, manufactured by Arena Pharmaceuticals has proven safe and is expected to obtain FDA approval. The now experimental diet pill has proven effective in a two year trial that included nearly 3200 participants. The only noted side effects were headaches and dizziness, according to a study in the New England Journal of Medicine.

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Mylan Receives FDA Approval For Nabumetone

Jim Marino — Fri, 16 Jul 2010 09:09:23 +0000

Mylan Inc. received the FDA approved for its generic version of the osteoarthritis and rheumatoid arthritis drug Nabumetone. The FDA approval allows Mylan to sell 500 milligram and 750 milligram tablets of Nabumetone. It is a nonsteroidal anti-inflammatory drug, which is a popular type of arthritis and inflammation treatment.

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FDA Approves Daytrana for ADHD

Jim Marino — Fri, 09 Jul 2010 19:19:32 +0000

The FDA has approved an expanded age range for a methylphenidate transdermal system (Daytrana; Shire, under license from Noven Pharmaceuticals, Inc) for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adolescents aged 13 to 17 years. Previously approved for use in children aged 6 to 12 years, the methylphenidate patch is indicated as an integral part of a total treatment program that may include psychological, educational, and social measures.

FDA reaffirms Shire exclusivity on attention-deficit-hyperactivity disorder drug

admin — Mon, 26 Oct 2009 15:38:51 +0000

The FDA has given Shire PLC reaffirmation on a prior decision to give the attention-deficit-hyperactivity disorder drug Vyvanse five years of market exclusivity. The drug was first approved in 2007 for children between 6 and 12 years old and then again in 2008 for adults. It has competition-free sales until February 23, 2012. GlaxoSmithKline’s sales force is helping in the promotion of the drug in the US.

MannKind awaiting FDA approval for its insulin powder and inhaler

admin — Mon, 12 Oct 2009 06:26:59 +0000

A small inhaler and insulin powder created by the MannKind Corporation is awaiting the FDA’s response for marketing purposes. After the FDA gives marketing approval for the insulin powder, called Afresa, patients can use a new, palm-size device that may let them discretely inhale a dose of insulin instead of using a needle. Afresa is inhaled into the lungs, where it dissolves and travels into the bloodstream.

Merck KGaA files for FDA approval for first oral MS drug

admin — Mon, 05 Oct 2009 06:55:03 +0000

Germany’s Merck KGaA filed for approval of its multiple sclerosis (MS) pill cladribine in the US in a bid to bring the first oral treatment against the debilitating disease to market. The company has submitted a New Drug Application (NDA) with the FDA two months after regulatory filing in Europe. The move follows a pivotal Phase III clinical trial, which showed in January that cladribine reduced the number of relapses per year in patients with some forms of MS by 58 percent compared with a placebo.

Salix Pharma gets FDA approval for Metozolv

admin — Tue, 29 Sep 2009 05:35:19 +0000

Salix Pharmaceuticals Ltd has received the FDA approval for the marketing of a fast-dissolving drug called Metozolv intended for treating diabetic gastroparesis and heartburn. The FDA’s approval covers 5 mg and 10 mg tablets of Metozolv ODT. The drug’s main ingredient, metoclopramide, has long been used to treat the two conditions in different forms. Diabetic gastroparesis is a condition in which the stomach takes too long to clear out food.