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What's New on the FDA Drugs Site
May 1, 2017

• Drug Approval Packages
  
  • DUPIXENT Injection
  • Xadago (safinamide) Tablets
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Safety Podcast: FDA approves label changes for use of general anesthetic and sedation drugs in young children
• FDA Drug Shortages
  • Asparaginase Erwinia Chrysanthemi (Erwinaze) (Updated - Currently in Shortage)
• National Drug Code Directory
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

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New and Generic Drug Approvals

May 1, 2017

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Imfinzi BLA #761069	Durvalumab	Injectable; Injection	ORIG-1	Astrazeneca Uk Ltd	Type 1 - New Molecular Entity	Approved

Showing 1 to 1 of 1 entries

April 28, 2017

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Advil Allergy and Congestion Relief NDA #022113	Chlorpheniramine Maleate; Ibuprofen; Phenylephrine Hydrochloride	Tablet; Oral	SUPPL-1	Pfizer	Efficacy	Approved
Alunbrig NDA #208772	Brigatinib	Tablet; Oral	ORIG-1	Ariad	Type 1 - New Molecular Entity	Approved
Atovaquone ANDA #207833	Atovaquone	Suspension; Oral	ORIG-1	Paddock Llc		Approved
Azelastine Hydrochloride and Fluticasone Propionate ANDA #207712	Azelastine Hydrochloride; Fluticasone Propionate	Spray, Metered; Nasal	ORIG-1	Apotex Inc		Approved
Brisdelle NDA #204516	Paroxetine Mesylate	Capsule; Oral	SUPPL-5	Sebela Ireland Ltd	Labeling	Approved
Bupropion Hydrochloride ANDA #090941	Bupropion Hydrochloride	Tablet, Extended Release; Oral	SUPPL-9	Mylan	Labeling	Approved
Bupropion Hydrochloride ANDA #090941	Bupropion Hydrochloride	Tablet, Extended Release; Oral	SUPPL-10	Mylan	Labeling	Approved
Clobetasol Propionate ANDA #207218	Clobetasol Propionate	Spray; Topical	ORIG-1	Akorn		Approved
Epi E Z Pen Jr NDA #019430	Epinephrine	Injectable; Intramuscular	SUPPL-67	Mylan Speciality Lp	Labeling	Approved
Epipen E Z Pen NDA #019430	Epinephrine	Injectable; Intramuscular	SUPPL-67	Mylan Speciality Lp	Labeling	Approved
Epipen Jr. NDA #019430	Epinephrine	Injectable; Intramuscular, Subcutaneous	SUPPL-67	Mylan Speciality Lp	Labeling	Approved
Epipen NDA #019430	Epinephrine	Injectable; Intramuscular, Subcutaneous	SUPPL-67	Mylan Speciality Lp	Labeling	Approved
Ethinyl Estradiol; Levonorgestrel ANDA #206201	Ethinyl Estradiol; Levonorgestrel	Tablet; Oral	ORIG-1	Mayne Pharma Inc		Tentative Approval
Fingolimod ANDA #207979	Fingolimod	Capsule; Oral	ORIG-1	Biocon Limited		Tentative Approval
Forteo NDA #021318	Teriparatide Recombinant Human	Injectable; Subcutaneous	SUPPL-51	Lilly	REMS	Approved
Humira BLA #125057	Adalimumab	Syringe	SUPPL-402	Abbvie Inc	Manufacturing (CMC)	Approved
Humira BLA #125057	Adalimumab	Vial	SUPPL-402	Abbvie Inc	Manufacturing (CMC)	Approved
Lo Simpesse ANDA #206852	Ethinyl Estradiol; Levonorgestrel	Tablet; Oral	ORIG-1	Aurobindo Pharma Ltd		Approved
Lorazepam ANDA #200542	Lorazepam	Injectable; Injection	ORIG-1	Sagent Agila	Not Applicable	Approved
Meperidine Hydrochloride ANDA #040110	Meperidine Hydrochloride	Tablet; Oral	SUPPL-5	West-Ward Pharms Int	Labeling	Approved
Meperidine Hydrochloride ANDA #088744	Meperidine Hydrochloride	Syrup; Oral	SUPPL-26	West-Ward Pharms Int	Labeling	Approved
Norethindrone and Ethinyl Estradiol ANDA #206864	Ethinyl Estradiol; Norethindrone	Tablet; Oral-28	ORIG-1	Accord Hlthcare		Approved
Oxazepam ANDA #070683	Oxazepam	Tablet; Oral	SUPPL-13	Sun Pharm Inds	Labeling	Approved
Ravicti NDA #203284	Glycerol Phenylbutyrate	Liquid; Oral	SUPPL-5	Horizon Theraps Inc	Efficacy	Approved
Rydapt NDA #207997	Midostaurin	Capsule; Oral	ORIG-1	Novartis Pharms Corp	Type 1 - New Molecular Entity	Approved
Rydapt NDA #207997	Midostaurin	Capsule; Oral	ORIG-2	Novartis Pharms Corp	Type 1 - New Molecular Entity	Approved
Tymlos NDA #208743	Abaloparatide	Injectable; Subcutaneous	ORIG-1	Radius Health Inc	Type 1 - New Molecular Entity and Type 4 - New Combination	Approved
Xalkori NDA #202570	Crizotinib	Capsule; Oral	SUPPL-19

Think Before You Ink: Are Tattoos Safe?

Are tattoos safe? Not always. More people are getting tattoos, and some have developed infections from contaminated inks, or had bad reactions to the inks themselves. The U.S. Food and Drug Administration (FDA) recommends asking these  important questions before getting a tattoo.

FDA Designates Medtronic Worldwide Voluntary Field Action on HVAD(TM) System Controllers and DC Adapters as Class I Recall

04/28/2017 03:59 PM EDT

Medtronic plc (NYSE: MDT) announced today that the U.S. Food and Drug Administration (FDA) has classified the company's recently initiated voluntary field action related to its HVAD(TM) System Controllers (serial numbers lower than CON300000) and DC Adapters (all serial numbers for product code 1435) as a Class I recall.

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

Drum roll please! The National Small Business Person of the Year is... During National Small Business Week, SBA has live events happening across the country. Here's the lineup for Monday, May 1: National Small Business Week Awards Live from Washington, DC Monday, May 1 12:30 pm-2:00 pm ET SBA Administrator Linda McMahon will announce the National Small Business Person of the Year, America's highest honor for a small business owner. One of the 56 state and territory winners will be crowned today live. Read more about the winners here [PDF]. SBA will also honor individuals in the following award categories: Exporter of the Year Small Business Prime Contractor of the Year Small Business Subcontractor of the Year 8(a) Graduate of the Year Dwight D. Eisenhower Awards for Excellence (for large prime contractors who use small businesses as suppliers and contractors) How you can participate: Watch the event live at www.sba.gov/nsbw and join the conversation on Twitter using the hashtag #SmallBusinessWeek. Vice President Mike Pence to address National Small Business Week award winners Monday, May 1 2:30 pm-3:30 pm ET Vice President Mike Pence will address the National Small Business Week award winners live from DC. He'll discuss the Trump Administration's priorities for the economy and the importance of celebrating entrepreneurship. There may also be a surprise guest, so tune in at 2:30 pm ET! How you can participate: Watch the event live at www.sba.gov/nsbw and join the conversation on Twitter using the hashtag #SmallBusinessWeek. It's not too late to register for our NSBW webinars... The U.S. Economic Outlook and Its Impact on Small Businesses Presented by Visa May 2, 2017 | 2:00-3:00 pm ET Register here 5 Fabulous Habits of Local Business Champions Presented by YP May 3, 2017 | 2:00-3:00 pm ET Register here Grow Your Business Online Presented by Google May 3, 2017 | 4:00-5:00 pm ET Register here The Future of Small Business Innovation Presented by Salesforce May 4, 2017 | 2:30-3:30 pm ET Register here How to Write Your Email Content in 15 Minutes or Less Presented by Constant Contact May 4, 2017 | 3:30-4:30 pm ET Register here Find the Hidden Money in America Presented by Chase May 4, 2017 | 5:00-6:00 pm ET Register here

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