FDA grants expanded approval to Janssen's diabetes drug | Seqirus' influenza vaccine gains FDA approval | Novo Nordisk's diabetes drug obtains FDA panel support
May 25, 2016
FDLI SmartBrief
News for the food and drug law community
Drugs & Biologics
FDA grants expanded approval to Janssen's diabetes drug
Janssen won approval from the FDA for Invokamet, a fixed-dose combination of canagliflozin and metformin hydrochloride, as a first-line treatment for adult type 2 diabetes patients who are not receiving canagliflozin or metformin. Invokamet was previously approved to treat patients whose diabetes was not sufficiently managed with canagliflozin or metformin alone.
Medscape (free registration) (5/24) 
Seqirus' influenza vaccine gains FDA approval
Seqirus' Flucelvax Quadrivalent, a four-strain inactivated influenza vaccine, has been approved by the FDA. The cell culture-derived vaccine is indicated for patients who are at least 4 years old.
Drug Store News (5/24) 
Novo Nordisk's diabetes drug obtains FDA panel support
An FDA advisory panel unanimously endorsed the approval of Novo Nordisk's type 2 diabetes treatment iDegLira, a combination of insulin degludec and liraglutide. Results from clinical studies showed that the single-injection drug helped patients manage their blood glucose levels.
Reuters (5/25) 
Rosacea treatment from Allergan accepted for FDA review
Allergan's new-drug application for its oxymetazoline HCl cream has been accepted for review by the FDA as a treatment for rosacea-associated persistent facial erythema in adults. A decision from the agency is expected in the first half of 2017.
Seeking Alpha (free registration) (5/24) 
Purdue resolves patent claims against Egalet
Purdue Pharma agreed to dismiss patent infringement claims against Egalet's Oxaydo, or oxycodone HCl, which is indicated for use in managing acute and chronic pain that is moderate to severe. The settlement involved no further legal action or financial obligations.
American City Business Journals/Philadelphia (5/24),  PharmaBiz.com (India) (5/24) 
UCB's patent on Vimpat to be reviewed
The remaining patent on UCB's epilepsy drug Vimpat, which is scheduled to expire in March 2022, will be reviewed by the US Patent and Trademark Office. The USPTO agreed to the review after it found that Argentum Pharmaceuticals, the generic-drug-maker challenging UCB's patent, could prove that some of UCB's patent claims are "unpatentable." A decision could come in a year.
Reuters (5/24) 
How To Successfully Select An ERP System in Eight Simple Steps
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Global Focus
Indian drugmakers cited by Italian regulator over GMP issues
JP Laboratories' Maharashtra plant and Krebs Biochemicals & Industries' Andhra Pradesh facility in India were cited by the Italian Medicines Agency over multiple good manufacturing practice violations. The regulator advised European regulatory bodies to ban the use and importation of drugs manufactured in the facilities.
FDAnews (5/25) 
Food & Dietary Supplements
Salmonella concerns cause second recall of raw milk, cream products
The California Department of Food and Agriculture has issued its second recall involving Organic Pastures Dairy's raw milk and cream after detecting salmonella in follow-up product testing. The latest recall covers products with a code date of June 1, 2016.
KFSN-TV (Fresno, Calif.) (5/24) 
Medical Devices
FDA panel backs St. Jude Medical's cardiac implant
An FDA panel has voted in favor of approving St. Jude Medical's Amplatzer PFO Occluder, an implantable wire-mesh device designed for preventing recurring ischemic strokes in patients with patent foramen ovale and a history of at least one unexplained stroke. The panel found that the device is safe, that its benefits outweigh the risks of use and that it is effective for its intended use.
Star Tribune (Minneapolis-St. Paul, Minn.) (5/24) 
Interbody fusion device from Interventional Spine cleared by FDA
The FDA has given Interventional Spine clearance for its 8-degree Lumbar Lordotic Opticage Expandable Intervertebral Body Fusion Device, an addition to the company's Opticage Expandable Interbody Fusion product line. The device, which can be implanted using transforaminal, posterior or lateral methods, is indicated to be used with autogenous bone graft to treat degenerative disc disease at one or two contiguous levels from L2 to S1.
BeckersSpine.com (5/24),  FDAnews (5/25) 
FDLI Items
New to Food and Drug Law Group: Emerging Issues and Hot Topics in Food Packaging complimentary lunch discussion, June 18, Washington, D.C.
Regulatory focus on food packaging materials has become increasingly active over the past few years, and recent developments have shifted the way in which industry, nongovernmental organizations and the FDA approach compliance. This focus is affecting new product development, regulation of existing materials and continued use of legacy products. Please RSVP to Laura Brown, lab@fdli.org, by June 10.
Advertising and Promotion Conference, Sept. 27-28, Washington, D.C.
FDLI Advertising Conference
This annual event brings together the regulated industries and the regulators responsible for overseeing the advertising and promotion of prescription drugs, medical devices, biologics and animal drugs. Learn more.
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