Lannett's treatment for opioid addiction OK'd by FDA | FDA fast-tracks Windtree's respiratory treatment for premature infants | Puma's NDA for breast cancer treatment under FDA review
September 21, 2016
FDLI SmartBrief
News for the food and drug law community
Drugs & Biologics
Lannett's treatment for opioid addiction OK'd by FDA
The FDA has approved Lannett's buprenorphine and naloxone sublingual tablets as a treatment for opioid dependence. The drug is a generic version of Suboxone Sublingual Tablets and will be available in 2 mg/0.5 mg and 8 mg/2 mg dosage strengths.
Seeking Alpha (free registration) (9/20) 
FDA fast-tracks Windtree's respiratory treatment for premature infants
Windtree Therapeutics' Aerosurf, or lucinactant for inhalation, has received fast-track designation from the FDA as a treatment for respiratory distress syndrome in premature infants. The drug is in a Phase IIb trial of premature infants with a gestational age of 26 to 32 weeks. (9/20) 
Puma's NDA for breast cancer treatment under FDA review
The FDA has accepted for review Puma Biotechnology's new-drug application for PB272, or oral neratinib, as a treatment for early-stage HER2-amplified breast cancer patients who received prior treatment with Roche Holding's Herceptin, or trastuzumab. A decision from the agency is expected by July 21 of next year.
BioCentury (9/20) 
FDA to review TherapeuticsMD's NDA for dyspareunia drug
TherapeuticsMD's new-drug application for Yuvvexy, or 17 beta-estradiol, has been accepted for review by the FDA for the treatment of dyspareunia in postmenopausal women. The agency's target action date for the NDA is May 7, 2017. (9/20) 
How ERP can help simplify manufacturing
Digital technologies are increasingly becoming integrated into the manufacturing landscape, driving the need for simpler ways to access information to support decision making. Read this whitepaper.
Global Focus
BMS' Opdivo under EMA review as bladder cancer treatment
Bristol-Myers Squibb's type II variation application for Opdivo, or nivolumab, has been validated by the European Medicines Agency. BMS is seeking expanded approval for the drug as a treatment for locally advanced unresectable or metastatic urothelial carcinoma in patients who experienced disease progression after platinum-based chemotherapy.
OncLive (9/20) 
EMA panel backs Janssen's Crohn's disease drug
The European Medicines Agency's Committee for Medicinal Products for Human Use has endorsed the approval of Janssen's Stelara, or ustekinumab, an interleukin-12/23 inhibitor. The treatment is recommended for moderate to severe active Crohn's disease in adults who are intolerant to, no longer respond to or did not have an adequate response to a tumor necrosis factor alpha antagonist or conventional therapy, or for those who cannot take such treatments because of medical contraindications.
PharmaTimes (U.K.) (9/20) 
White paper: Create effective enterprise training programs
The top two learning priorities for companies are product training and compliance. Are your teams — your internal workforce and your external partners— prepared to do this? If not, how much money is this costing you?
Read the whitepaper now
Food & Dietary Supplements
Meat products in Wash. recalled due to mislabeling
About 82 pounds of beef flank steak, hot Italian sausage and ground lamb products are being recalled by Colville, Wash.-based Gallo Meats after the Department of Agriculture's Food Safety and Inspection Service found that the products were uninspected but had the USDA mark of inspection applied to their packages. The recalled products, which were packed in 12- to 16-ounce Cryovac packages, were sold in Washington state, bear the establishment number "EST. 09334" inside the USDA mark of inspection and were produced between April 20 and July 27, 2016. (9/20),  The Statesman-Examiner (Colville, Wash.) (9/20) 
Medical Devices
Boston Scientific's next-gen aortic valve system wins EU approval
European regulators have granted Boston Scientific CE mark approval for its Lotus Edge transcatheter aortic valve system, which is designed for use in patients with severe aortic stenosis who have a high risk for surgical valve replacement. The system, which builds on the company's Lotus Valve System, features the Adaptive Seal technology for minimizing leaking and comes with a more flexible and narrower catheter for facilitating delivery.
FDAnews (9/20), (9/20) 
EU OKs ViewRay's next-gen MRI-guided radiation therapy system
European regulators have given ViewRay CE mark approval for its MRIdian Linac technology, an advanced linear, accelerator-based, MRI-guided radiation therapy system that is based on the company's first-generation MRIdian system. The system uses cobalt with linear accelerator technology and is available in the US for nonclinical research use.
FDAnews (9/20) 
FDLI Items
Introduction to Drug Law and Regulation Course, Oct. 19-20, Union, N.J.
FDLI Drug Law and Regulation
The course addresses the FDA's Safety and Innovation Act, Risk Evaluation & Mitigation Strategy (REMS), patent and exclusivity issues, Rx to OTC switches, Good Manufacturing Practices (GMP), advertising and promotion, compliance, and enforcement.  Learn more.
One week away! Advertising & 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. View the agenda.
Learn more about FDLI:
About FDLI | Join FDLI | Conferences | Publications
powered by
Attorney - Food and Drug Associate
Scientist - Chemist - Food and Drug
Scientist - Toxicologist - Food and Drug
Do what you feel in your heart to be right, for you'll be criticized anyway.
Eleanor Roosevelt,
first lady, diplomat and activist
Sign Up
SmartBrief offers 200+ newsletters
Learn more about the SmartBrief audience
Subscriber Tools:
Contact Us:
Advertising  -  Meryl Harold
P: 202.407.7828
Jobs Contact  -
Editor  -  Lisa Gough
Mailing Address:
SmartBrief, Inc.®, 555 11th ST NW, Suite 600, Washington, DC 20004
© 1999-2016 SmartBrief, Inc.®
Privacy policy |  Legal Information