U.S.A.'s interesting latest news

What's New on the FDA Drugs Site

June 9, 2017

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Shortages
  • Disopyramide Phosphate (Norpace) Capsules (Updated - Currently in Shortage)
  • Epirubicin Hydrochloride Injection (New - Discontinuation)
• FDA requests removal of Opana ER for risks related to abuse
• Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (updated)
• Pediatric Exclusivity Granted (updated)
• National Drug Code Directory: Download the New NDC Express Mobile Application
• Wholesale Distributor and Third-Party Logistics Providers Reporting(updated) 

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New and Generic Drug Approvals

June 9, 2017

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Memantine Hydrochloride ANDA #205784	Memantine Hydrochloride	Capsule, Extended Release; Oral	ORIG-1	Anchen Pharms		Approved

June 8, 2017

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Lo/Ovral-28  NDA #017802	Ethinyl Estradiol; Norgestrel	Tablet; Oral-28	SUPPL-29	Wyeth Pharms	Labeling	Approved
Mirena  NDA #021225	Levonorgestrel	Intrauterine Device; Intrauterine	SUPPL-38	Bayer Hlthcare	Efficacy	Approved
Truvada  NDA #021752	Emtricitabine; Tenofovir Disoproxil Fumarate	Tablet; Oral	SUPPL-52	Gilead	REMS	Approved
Clonidine Hydrochloride  ANDA #071783	Clonidine Hydrochloride	Tablet; Oral	SUPPL-17	Chartwell Molecules	Labeling	Approved
Clonidine Hydrochloride  ANDA #071784	Clonidine Hydrochloride	Tablet; Oral	SUPPL-17	Chartwell Molecules	Labeling	Approved
Clonidine Hydrochloride  ANDA #071785	Clonidine Hydrochloride	Tablet; Oral	SUPPL-19	Chartwell Molecules	Labeling	Approved
Gabapentin  ANDA #076403	Gabapentin	Solution; Oral	SUPPL-2	Acella Pharms Llc	Labeling	Approved
Scandonest Plain  ANDA #088387	Mepivacaine Hydrochloride	Injectable; Injection	SUPPL-35	Deproco	Manufacturing (CMC)	Approved
Scandonest Plain  ANDA #088387	Mepivacaine Hydrochloride	Injectable; Injection	SUPPL-35	Deproco	Manufacturing (CMC)	Approved
Diltiazem Hydrochloride  ANDA #203023	Diltiazem Hydrochloride	Capsule, Extended Release; Oral	ORIG-1	Sun Pharm Inds Ltd		Approved
Asenapine  ANDA #206098	Asenapine	Tablet; Sublingual	ORIG-1	Alembic Pharms Ltd		Tentative Approval
Nystatin  ANDA #208581	Nystatin	Powder; Topical	ORIG-1	Nesher Pharms		Approved
Cigensa Norethindrone Acetate;Ethinyl Estradiol; Ethinyl Estradiol;Ferrous Fumarate  ANDA #209014	Cigensa Norethindrone Acetate;Ethinyl Estradiol; Ethinyl Estradiol;Ferrous Fumarate	Tablet; Oral	ORIG-1	Aurobindo Pharma Ltd		Tentative Approval
Siliq  BLA #761032	Brodalumab	Injectable; Injection	SUPPL-1	Valeant Luxembourg	REMS	Approved

  

CC Kitchens Announces Recall of Limited Number of Salad and Slaw Kits Containing Leafy Greens Due to Possible Health Risk

06/12/2017 01:11 PM EDT

CC Kitchens is recalling a limited number of salad and slaw kits due to a possible health risk from Listeria. No contamination has been reported to have occurred on any product, nor have any illnesses been reported to date in association with the recall. Rather, the recall was initiated by the processor of certain leafy greens in an abundance of caution due to instances of positive test results for the presence of Listeria being identified by the processor during environmental testing of portions of their facility.

For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.You are subscribed to Recalls, Market Withdrawals and Safety Alerts for U.S. Food & Drug Administration (FDA).

This information has recently been updated and is now available.

United Pet Group Voluntary Recalls Multiple Brands of Rawhide Chew Products for Dogs Due to Possible Chemical Contamination

06/10/2017 04:41 PM EDT

United Pet Group, a division of Spectrum Brands, Inc. is voluntarily recalling multiple brands of packages of rawhide dog chew products that were distributed to retail outlets and sold online in the U.S. The recall involves the brands and products described below.

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

Slade Gorton Co. Inc. Issues Allergy Alert On Undeclared Milk

06/12/2017 01:21 PM EDT

Slade Gorton, Boston, MA is recalling the following products because they may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

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

June 12, 2017

We began sending all of the following cases from the Nebraska Service Center to the Lockbox:

• N-600K, Application for Citizenship and Issuance of Certificate Under Section 322 (Military applications only)
• N-400, Application for Naturalization (Military applications only)

https://www.uscis.gov/workload-transfers

Tyson Foods Inc. Recalls Ready-To-Eat Breaded Chicken Products Due to Misbranding and Undeclared Allergens

Tyson Foods Inc., is recalling approximately 2.5 million pounds of ready-to-eat breaded chicken products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced. The products could contain milk, a known allergen, which is not declared on the product label. Products Recalled: The RTE breaded chicken items were produced and packaged on various dates from Aug. 17, 2016 through Jan.14, 2017. The following products are subject to recall: [View Labels (PDF). To see the full list of affected products, visit the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) website. Consumer Questions: Consumers with questions about this recall can contact Christina Self, Supervisor-Consumer Relations, at (866) 328-3156. Media with questions about the recall can contact, Caroline Ahn, Communications Manager, at (312) 614-6047. Consumers with food safety questions can "Ask Karen," the FSIS virtual representative available 24 hours a day at AskKaren.gov or via smartphone at m.askkaren.gov. The toll-free USDA Meat and Poultry Hotline 1-888-MPHotline (1-888-674-6854) is available in English and Spanish and can be reached from 10 AM to 6 PM (ET) Monday through Friday. Recorded food safety messages are available 24 hours a day. The online Electronic Consumer Complaint Monitoring System can be accessed 24 hours a day at: https://www.fsis.usda.gov/reportproblem. When was the last time you’ve revisited your workplace safety plan? Not only is it the law, but it also can ensure that you and your employees are always safe. In honor of National Safety Month, we would like to highlight four resources that will help you identify unsafe behaviors, create opportunities for improvement and help you (and your employees) make well-informed safety decisions on a daily basis. >Read more Call for Comments on NAFTA Modernization and Economic Impact Panel Participants The Office of the United States Trade Representative (USTR) is seeking public comments on matters relevant to the modernization of NAFTA in order to inform development of U.S. negotiating positions. Small businesses may participate by commenting on how NAFTA has impacted their businesses. Submit written comments or written notification of intent to testify along with a summary of your testimony here by June 12. Savings Plans For Small Businesses This self-paced training exercise will give you an overview of savings plans and strategies for your small business. Learn about the contingency and long-term savings, tax breaks, retirement savings and much more. School’s Out for Summer...But Not Your Small Business Whether you’re more excited about firing up the grill, relaxing on the beach or being more active, the warm summer months can provide challenges for your small business — especially if you’re based at home. It doesn’t take much for a seasonal change to derail your focus. Maybe your kids are home from school, or a seasonal slump has left you feeling distracted. Sometimes a little extra sunshine is a distraction enough. But the arrival of the lazy, hazy days of summer doesn’t mean you can forget about your small business goals. Here’s how to stay focused when you’re working at home this summer. Starting a High-Tech Business? You May be Eligible for Government Funding Looking to start or grow your high-tech entrepreneurial venture? Need financing to help fund research and development (R&D) efforts and realize your business potential? The U.S. federal government can help! In fact, annually, nearly 5,000 small businesses receive over $2.5 billion in federal government grants and contracts to help them carry out the R&D necessary to develop and bring high-tech products to market through the Small Business Innovation Research Program (SBIR). SBIR, affectionately known as America’s Seed Fund, is the largest source of non-dilutive, early stage seed capital in the world.