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FDA recently announced these approvals:
• Schwartz Bioscience's Neupro (rotigotine transdermal system), a skin patch designed to treat symptoms of early Parkinson's disease. The agency said rotigotine is a drug not previously approved in the U.S. Neupro is the first transdermal patch for treating Parkinson's disease symptoms.
Neupro's effectiveness was demonstrated in one fixed-dose response study and two flexible-dose studies involving 1,154 patients with Parkinson's disease who were not taking other Parkinson's medications. The most common side effects included skin reactions at the patch site, dizziness, nausea, vomiting, drowsiness, and insomnia. FDA said most of the side effects are typical of this drug class. Other potential safety concerns include sudden onset of sleep while engaged in routine activities such as driving or operating machinery, hallucinations, and decreased blood pressure on standing up.
• FDA has cleared for marketing the first respirators that can help reduce a user's exposure to airborne germs during a public health medical emergency such as an influenza pandemic. The two 3M filtering facepiece respirators will be available to the general public without a prescription.
The agency said the devices also are certified by the National Institute for Occupational Safety and Health (NIOSH) as N95 filtering facepiece respirators for use in occupational settings in accordance with an appropriate respiratory protection program. An N95 filtering facepiece respirator is a type of face mask that fits tightly over the nose and mouth. It is made of fibrous material that is designed to filter out at least 95% of very small airborne particles. The filter and a proper fit determine the product's effectiveness.
Many companies make N95 respirators for workplaces, including healthcare settings, but 3M's are the first to receive FDA clearance for use by the public during public health medical emergencies to reduce exposure to airborne germs. FDA is requiring those who want to market respirators for use during public health medical emergencies to assure that they are certified by NIOSH to provide adequate filtration without hampering people's ability to breathe. Companies also must conduct fit assessment testing, conduct biocompatibility testing to reduce the chance for allergic skin reaction, and provide instructions that will enable wearers to achieve a protective fit and use the devices properly.
3M evaluated fit characteristics in healthy adults to determine that a user could achieve a protective fit following the label instructions. The company measured how many airborne test particles were able to get inside the respirator through small leaks between the edges of the respirator and the wearer's face.