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U.S.FOOD AND DRUG ADMINISTRATION

What's New on the FDA Drugs Site

March 10, 2017

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• National Drug Code Directory
• Wholesale Distributor and Third-Party Logistics Providers Reporting(updated)

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New and Generic Drug Approvals

March 9, 2017

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Cefotan  NDA #050588	Cefotetan Disodium	Injectable; Injection	SUPPL-32	Teligent Pharma Inc	LABELING	Approved
Epanova  NDA #205060	Omega-3-Carboxylic Acids	Capsule; Oral	SUPPL-3	Astrazeneca Pharms	LABELING	Approved
Epanova  NDA #205060	Omega-3-Carboxylic Acids	Capsule; Oral	SUPPL-6	Astrazeneca Pharms	LABELING	Approved
Loperamide Hydrochloride NDA #021855	Loperamide Hydrochloride	Capsule; Oral	SUPPL-6	Bionpharma Inc	LABELING	Approved
Mefoxin  NDA #050517	Cefoxitin Sodium	Injectable; Injection	SUPPL-53	Mylan Institutional	LABELING	Approved
Promacta  NDA #022291	Eltrombopag Olamine	Tablet; Oral	SUPPL-17	Novartis Pharms Corp	LABELING	Approved
Promacta  NDA #207027	Eltrombopag Olamine	For Suspension; Oral	SUPPL-2	Novartis Pharms Corp	LABELING	Approved
Voriconazole  NDA #208562	Voriconazole	Injectable; Injection	ORIG-2	Xellia Pharms Aps	TYPE 5

Whole Foods Market Expands Vulto Creamery Recall Because of Public Health Risk

03/13/2017 02:27 PM EDT

In response to Vulto Creamery’s expanded recall of raw milk cheeses, Whole Foods Market is voluntarily expanding its recall to include Andes, Hamden and Walton Umber cheeses sold in eight stores in Massachusetts, New Jersey and New York. The cheeses have the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, pregnant women and others with weakened immune systems.

For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.

Don't Get Caught off Guard

Be prepared for seasonal storms that can affect your area: Make sure your emergency kit is up to date and easy to access. If your heat goes out, keep the doors closed off to rooms you are not using and close your blinds or curtains to keep in some heat. Never use a generator, grill, camp stove or other gasoline, propane, natural gas or charcoal burning device inside a home, garage, basement, crawlspace or any partially enclosed area. Learn how to shut off water valves and avoid burst pipes due to freezing conditions. If you are using a fireplace, make sure you use a screen and it is properly ventilated. Stay on top of weather changes in your area by checking the National Weather Service. Business Opportunity Scheme Operators Banned from Telemarketing and Selling Investment Opportunities; Will Return Millions to Consumers The operators of a telemarketing scheme charged with bilking millions of dollars from consumers, many of whom are seniors or military veterans on fixed income, will pay approximately $7.5 million in consumer redress under a settlement with the Federal Trade Commission. The stipulated final order also prohibits the defendants – who operated under names such as Building Money, Prime Cash, Wyze Money, and Titan Income – from telemarketing, marketing investment opportunities, and selling or otherwise benefiting from consumers’ personal information. In October 2016, the FTC filed a federal court complaint alleging that the defendants sold bogus online investment opportunities to people across the nation. The descriptions of the “opportunity” varied, but typically involved buying or investing in e-commerce related websites, or participating in a profit-sharing program involving credit card companies and e-commerce websites. The defendants got hefty payments from consumers – some exceeded $20,000. At the FTC’s request, a federal court halted the scheme and froze the defendants’ assets pending litigation. The FTC’s complaint names the scheme’s owners, Susan Rodriguez, Matthew Rodriguez and William “Matt” Whitley, and their companies, Advertising Strategies LLC, Internet Advertising Solutions LLC, Internet Resource Group Inc., Network Advertising Systems LLC, Network Professional Systems LLC and Network Solutions Group Inc. They are charged with violating the FTC Act and the Telemarketing Sales Rule, including calling numbers on the National Do Not Call Registry. The stipulated final order imposes a $25 million judgment, partially suspended upon the defendants’ surrender of assets. The full judgment will become due immediately if they have misrepresented their financial condition. The Commission vote approving the stipulated final order was 2-0. The U.S. District Court for the District of Arizona entered the order on March 8, 2017. NOTE: Stipulated final orders have the force of law when approved and signed by the District Court judge. To learn more, read the FTC’s information on Business Opportunity Scams and on Investment Risks. The Federal Trade Commission works to promote competition, and protect and educate consumers. You can learn more about consumer topics and file a consumer complaint online or by calling 1-877-FTC-HELP (382-4357).  Like the FTC on Facebook, follow us on Twitter, read our blogs and subscribe to press releases for the latest FTC news and resources.