Medical Product Guide» FDA applications

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.

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.

New style of breast implant close to the FDA approval

admin — Mon, 21 Sep 2009 05:32:37 +0000

“410B,” a new style of breast implant, could reduce healing time and ease pain. Although it is not yet approved by the FDA, the plastic surgeon who created it calls it the “most studied breast implant ever.” Also known as the ‘Gummy Bear Implant,’ the product is the only implant in history that stimulated the development of techniques that let people recover in 24 hours and go out for dinner on the night of surgery, Plastic Surgeon John Tebbetts said proudly.

Cimzia gets FDA nod for Crohn's Disease

Jim Marino — Thu, 07 Aug 2008 18:24:07 +0000

The FDA has approved UCB Corp’s Cimzia® (certolizumab pegol) for the treatment of Crohn’s Disease (CD). The company aims to make the drug, which is a new, promising option for patients suffering from moderate to severe Crohn’s Disease, available in the U.S. in the next few days. Cimzia is the first and only pegylated anti-TNF? (anti-tumor necrosis factor-?). The excessive production of TNF? has been associated with a wide variety of diseases.

FDA approves iFix Interference Screw System

Jim Marino — Fri, 29 Feb 2008 17:03:33 +0000

Cayenne Medical Inc. has received FDA clearance for the iFix(TM) Interference Screw System for use in bone-tendon-bone ACL reconstruction procedures. These are the first FDA approved screws to hit the market that are made from polyetheretherketone (PEEK) plastic, which is radiolucent and highly biocompatible and has superior biomechanical strength. PEEK is a completely bio-inert material and, hence, screws made from this material do not result in foreign body reactions in patients.

Noninvasive treatment for depression passes test

Jim Marino — Thu, 21 Feb 2008 21:27:38 +0000

Israel-based Brainsway Ltd. reported positive results from the final stage of testing its noninvasive Transcranial Magnetic Stimulation (TMS) treatment for depression. TMS is a noninvasive technique for applying brief magnetic pulses to the brain. The company said that it had obtained satisfactory results from its first efficacy test on 64 patients. Brainsway now intends to file for an application for CE Mark certification from the EU and subsequently aim for an FDA approval.

FDA delays Requip approval

Jim Marino — Wed, 06 Feb 2008 19:35:19 +0000

The FDA has delayed the final approval of GlaxoSmithKline Plc’s Requip XL. The drug is a once-a-day oral treatment for Parkinson’s disease, a progressive neurological disorder that slows body movement. The delay affects SkyePharma Plc, since it uses the company’s slow release technology. The FDA is expected to announce a decision on the drug’s approval in the second quarter of this year.

Taro gets FDA nod for Flo-Pred

Jim Marino — Tue, 29 Jan 2008 17:54:17 +0000

Taro Pharmaceutical Industries Ltd. has received FDA approval for its NDA (New Drug Application) for Flo-Pred (prednisolone acetate oral suspension) in its NonSpil liquid drug delivery system. Flo-Pred is an anti-inflammatory agent used in the treatment of asthma, certain allergic and dermatologic conditions as well as various other indications. Taro expects to launch the product later this year. Adverse reactions common to corticosteroids include fluid retention, high blood pressure, high blood sugar, mood swings and weight gain.

Johnson & Johnson submits NDA for tapentadol

Jim Marino — Fri, 25 Jan 2008 15:46:43 +0000

Johnson & Johnson Pharmaceutical Research & Development has submitted an NDA (New Drug Application) for its tapentadol hydrochloride immediate release (IR) tablets to the FDA. Tapentadol is an investigational oral analgesic for treating moderate to severe acute pain. Clinical studies show that tapentadol has efficacy comparable to strong opioids. Over 25 million Americans suffer from acute pain every year, according to the American Pain Foundation.