FDA orphan designation granted to Selten's pulmonary arterial hypertension drug | GSK's asthma drug wins FDA panel's backing for use in adults | FDA gives tentative approval to Aurobindo's generic seizure treatment

March 20, 2015
FDLI SmartBrief
News for the food and drug law community

Drugs & Biologics
FDA orphan designation granted to Selten's pulmonary arterial hypertension drug
The FDA granted orphan drug status to Selten Pharma's experimental drug SPI-026, or tacrolimus, as a treatment for pulmonary arterial hypertension. The firm said animal studies show the drug holds promise in reversing the effects of PAH by activating the bone morphogenetic protein receptor type II pathway. Pharmaceutical Business Review Online (3/19) Share: Email
GSK's asthma drug wins FDA panel's backing for use in adults
An FDA advisory panel voted 16-4 Thursday to endorse the approval of GlaxoSmithKline's chronic obstructive pulmonary disease drug Breo Ellipta for adult asthma patients. The panel did not recommend the medication for use in patients ages 12 to 17 and suggested conducting a large safety trial in adolescents and adults. A final decision from the FDA is expected by April 30. Reuters (3/19) Share: Email
FDA gives tentative approval to Aurobindo's generic seizure treatment
Aurobindo Pharma obtained tentative FDA approval for its Lacosamide pills in four strengths to treat partial-onset seizures in people who are 17 and older and are diagnosed with epilepsy. The pills are a generic version of Vimpat, developed by USB. The Economic Times (India)/Press Trust of India (3/19) Share: Email
Amicus to file for accelerated approval of Fabry disease drug
Amicus Therapeutics will seek accelerated FDA approval for its experimental Fabry disease drug migalastat in the second half of 2015 and will request approval from European regulators in the second quarter. The decision comes after a late-stage trial yielded positive results in treating the disease. The Washington Times/The Associated Press (3/19) Share: Email
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EU approves bone screw system from Silver Bullet
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Giant Eagle cookies pulled from supermarkets over undeclared milk
Giant Eagle is pulling its Giant Eagle-brand seasonal cutout cookies from Giant Eagle and Market District supermarkets in West Virginia, Maryland, Ohio and Pennsylvania because they may contain milk not declared on the label. The cookies were sold individually, as well as in 2-, 10- and 12-count packages. Food Poisoning Bulletin (3/19) Share: Email
Undeclared milk prompts StoneRidge to pull pork tenderloin
About 31,851 pounds of StoneRidge Roasted Garlic Pork Tenderloin are being pulled by StoneRidge Wholesale Division of Wisconsin because of misbranding and milk not declared on the label. Affected products are 1- to 2-pound vacuum-sealed packages that were produced from March 2, 2014, to March 16, 2015, with "use or freeze by" dates until April 30, 2015. Food Poisoning Bulletin (3/19) Share: Email
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Medical Devices
GOP senators include medical device tax repeal in budget proposal
A budget proposal that includes language to repeal the 2.3% excise tax on medical devices was introduced Wednesday by Republicans in the U.S. Senate. The medical device tax "has harmed health care innovation, stifled job creation and burdened the delivery of quality patient care," said Sen. Orrin Hatch, R-Utah. "It is time to end this tax so that more resources can be devoted to health care innovation." MassDevice.com (Boston) (3/19) Share: Email
FDA clears advanced PAD testing technology from Semler
A next-generation system developed by Semler Scientific for peripheral artery disease testing has received 510(k) clearance from the FDA. The Oregon medtech firm said the device, to be launched later this year, offers efficient access to data from electronic medical record systems. FDAnews (3/19) Share: Email
FDA labels Medtronic's sheath recall as Class I
A recall involving Medtronic's FlexCath Select Steerable Sheath has been categorized by the FDA as Class I. The company issued a voluntary recall after reports of debris coming from the Model 990065 sheath's hemostasis valve. Medtronic said there were no reports of death or serious injury. FDAnews (3/19) Share: Email
FDLI Items
Explore the Annual Conference sessions relevant to YOU!
The new interactive FDLI Annual Conference website lets you explore sessions based on your interests and industry. It's as easy as 1,2,3! Click on your industry, view a customized agenda and register. At our biggest conference of the year, we want to make it convenient for our attendees to find their relevant content. Enjoy the new look and experience! Share: Email
Save the date for our next Introductory Medical Device Law and Regulation Course
Whether you are new to the medical device industry or a seasoned regulatory affairs/legal professional, you can benefit from this two-day interactive program! Experts will thoroughly review essential concepts involving current medical device regulatory developments. Attending this training course can help you and your clients comply with FDA regulations, get products approved and help minimize regulatory problems. Mark your calendar -- this course will be held on June 16 and 17. Stay tuned for more details and check out all of FDLI's upcoming events! Share: Email
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