Medical Product Guide

Dey Launches Needle-Protected EpiPen(R) (Epinephrine) Auto-Injector with Enhanced Features

Jim Marino — Mon, 09 Nov 2009 09:35:27 +0000

Dey Pharma, L.P., has launched a newly designed, patient-friendly EpiPen® Auto-Injector 0.3/0.15 mg. This next-generation EpiPen Auto-Injector maintains the simplicity, speed, safety and reliability of EpiPen Auto-Injector with several new, user-friendly features, including being the only auto-injector with needle-protection before and after use. Side effects may include an increase in heart rate, a stronger or irregular heartbeat, sweating, nausea and vomiting. If you have Parkinson’s disease, your symptoms may temporarily get worse.

Palomar to launch Anti-Aging Laser Device without JJDC

Jim Marino — Mon, 02 Nov 2009 09:16:44 +0000

Palomar Medical Technologies Inc. will go ahead with the commercialization of its FDA-cleared home-use laser device for treatment of periorbital wrinkles, despite the termination of its commercialization agreement with Johnson & Johnson. Palomar plans to launch the products during the second half of next year. With the agreement cancellation, JJCC avoids having to commit to the significant level of funding required to successfully launch a new product into the mass market.

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

Jim Marino — 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.

FDA asks companies to stop marketing codeine sulphate

Jim Marino — Mon, 19 Oct 2009 14:39:35 +0000

The FDA has directed Glenmark Generics Inc and three other manufacturers to stop marketing unapproved codeine sulphate tablets in the US market. The drug is an old narcotics product widely used to treat pain. These products, marketed in 30mg and 60mg form, lack FDA approval and the agency has no evidence that they are safe and effective.

MannKind awaiting FDA approval for its insulin powder and inhaler

Jim Marino — 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

Jim Marino — 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

Jim Marino — 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.

New style of breast implant close to the FDA approval

Jim Marino — 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.

Telavancin receives approval from the FDA

Jim Marino — Mon, 14 Sep 2009 04:54:23 +0000

Theravance Inc and partner Astella Pharma won the FDA approval for their superbug-fighting drug telavancin. The drug will hit the market in the fourth quarter as a treatment for adults with complicated skin and skin structure infections caused by methicillin-resistant Staphylococcus aureus, commonly known as the superbug MRSA and other Gram-positive bacteria. The drug is the first approved specifically to target MRSA, which currently is treated largely with the antibiotic vancomycin.

FDA approves INTUNIV

Jim Marino — Mon, 07 Sep 2009 07:50:23 +0000

Shire has received approval from the FDA for INTUNIV (guanfacine) Extended Release Tablets for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17 years. The once-daily INTUNIV drug is expected to be available in the US pharmacies by November and will come in four dosage strengths (1 mg, 2 mg, 3 mg, and 4 mg).