USFDA: New and Generic Drug Approvals: 17 NOV 2014

New and Generic Drug Approvals

November 17, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Cutivatefluticasone propionateLotion;TopicalFougera PharmsManufacturing Change or Addition
Hepatamine 8%amino acidsInjectable;InjectionB BraunManufacturing Change or Addition
Nucyntatapentadol hydrochlorideSolution;OralJanssen PharmsLabeling Revision
Pegintronpeginterferon alfa-2bSyringeScheringLabeling Revision
Pegintronpeginterferon alfa-2bVialScheringLabeling Revision
Sylatronpeginterferon alfa-2bVialScheringLabeling Revision
Unasynampicillin sodium; sulbactam sodiumInjectable;InjectionPfizerLabeling Revision

USFDA: New and Generic Drug Approvals: 16 NOV 2014

New and Generic Drug Approvals

November 16, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Choline C-11choline c-11Injectable;IntravenousMcprfManufacturing Change or Addition
Fiorinal W/Codeineaspirin; butalbital; caffeine; codeine phosphateCapsule;OralWatson Labs IncManufacturing Change or Addition
Injectaferferric carboxymaltoseInjectable;IntravenousLuitpoldManufacturing Change or Addition
Morphine Sulfatemorphine sulfateSolution;Intramuscular, IntravenousBd RxManufacturing Change or Addition
Resectisol In Plastic ContainermannitolSolution;IrrigationB BraunManufacturing Change or Addition
Zytigaabiraterone acetateTablet;OralJanssen BiotechManufacturing Change or Addition

USFDA: New and Generic Drug Approvals: 15 NOV 2014

New and Generic Drug Approvals

November 15, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Ferric Citrateferric citrateTablet;OralKeryx BiopharmsLabeling Revision

USFDA: New and Generic Drug Approvals: 14 NOV 2014

New and Generic Drug Approvals

November 14, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
AndrogeltestosteroneGel, Metered;TransdermalAbbvieLabeling Revision
AndrogeltestosteroneGel;TransdermalAbbvieLabeling Revision
AvastinbevacizumabVial; IntravenousGenentechEfficacy Supplement with Clinical Data to Support
CampathalemtuzumabVial; IntravenousIlex PharmaceuticalsLabeling Revision
Flovent Hfafluticasone propionateAerosol, Metered;InhalationGlaxo Grp LtdLabeling Revision
FycompaperampanelTablet;OralEisai IncLabeling Revision
Obredonhydrococone bitartrate; guaifenesinSolution;OralSovereign Pharma LlcApproval
OmniscangadodiamideInjectable;InjectionGe HealthcareLabeling Revision
Precedexdexmedetomidine hydrochlorideInjectable;InjectionHospiraLabeling Revision
Precedexdexmedetomidine hydrochlorideInjectable;InjectionHospiraManufacturing Change or Addition
SovaldisofosbuvirTablet;OralGilead Sciences IncLabeling Revision
TaxoteredocetaxelInjectable;InjectionSanofi Aventis UsLabeling Revision
Tecfideradimethyl fumarateCapsule, Delayed Release;OralBiogen Idec IncLabeling Revision
Vyvanselisdexamfetamine dimesylateCapsule;OralShire DevelopmentLabeling Revision

Health Canada reviewing possible safety concerns with certain long-term antiplatelet (blood thinner) therapy; Benefits of treatment still outweigh potential risks


Health Canada is aware of and will be reviewing new evidence on the safety of long-term use of the prescription blood-thinners clopidogrel (Plavix) and prasugrel (Effient).
Clopidogrel and prasugrel reduce the risk of blood clots in patients who have had a heart attack, stroke or related blood clotting diseases. Dual antiplatelet therapy is the use of a blood thinner in combination with ASA (acetylsalicylic acid or Aspirin). It is commonly used following coronary stent implantation to reduce the risk of blood clots. Coronary stents are tiny tubes that are implanted in narrow or weak heart arteries to maintain blood flow to the heart.
It is important to note that Health Canada has not reached new conclusions or made recommendations regarding clopidogrel or prasugrel safety at this time. The benefits of clopidogrel and prasugrel in protecting against blood clots continue to outweigh their risks when used as directed.
The new evidence is from the Dual Antiplatelet Therapy (DAPT) Study, a large-scale, multi-national clinical trial that evaluated 12 versus 30 months of clopidogrel or prasugrel use with ASA, known as dual antiplatelet therapy. The study looked at how these drugs can prevent blood clots in patients with coronary stents. Its findings were recently published in the New England Journal of Medicine.
Health Canada is evaluating preliminary information from the study, which found that 30 months of dual antiplatelet therapy was beneficial in reducing blood clots and heart attacks relative to 12 months, but saw an increase in deaths due to non-cardiovascular causes in the 30-month group versus the 12-month group.
Health Canada will continue to evaluate the available information from this trial along with other information, and is aware of the recent communication issued by the U.S. Food and Drug Administration. Health Canada will take appropriate action based on the results of the review once it is complete, including communicating new safety information to health professionals and Canadians as necessary.
Patients with questions or concerns about their dual antiplatelet therapy should talk to their doctor.  Patients should not stop using clopidogrel and prasugrel unless on the advice of their healthcare professional. Stopping treatment may increase the risk of blood clots, which can be fatal.

USFDA: New and Generic Drug Approvals: 13 NOV 2014

New and Generic Drug Approvals

November 13, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
ActemratocilizumabInjectable; InjectionGenentechLabeling Revision
Advair Diskus 100/50fluticasone propionate; salmeterol xinafoatePowder;InhalationGlaxo Grp LtdLabeling Revision
Advair Diskus 250/50fluticasone propionate; salmeterol xinafoatePowder;InhalationGlaxo Grp LtdLabeling Revision
Advair Diskus 500/50fluticasone propionate; salmeterol xinafoatePowder;InhalationGlaxo Grp LtdLabeling Revision
Advair Hfafluticasone propionate; salmeterol xinafoateAerosol, Metered;InhalationGlaxo Grp LtdLabeling Revision
Flovent Diskus 100fluticasone propionatePowder;InhalationGlaxo Grp LtdLabeling Revision
Flovent Diskus 250fluticasone propionatePowder;InhalationGlaxo Grp LtdLabeling Revision
Flovent Diskus 50fluticasone propionatePowder;InhalationGlaxo Grp LtdLabeling Revision
MycobutinrifabutinCapsule;OralPharmacia and UpjohnLabeling Revision
ZolmitriptanzolmitriptanTablet;OralSun Pharma GlobalApproval

USFDA CFSAN - FDA Published Updated Guidance for Industry on Food Facility Registration...

The Food and Drug Administration is announcing the availability of a guidance for industry entitled "Questions and Answers Regarding Food Facility Registration (Sixth Edition)."  The guidance includes one new  question and answer in addition to the questions and answers in the Fifth Edition of the guidance document, which is being added in light of an ongoing rulemaking under the FDA Food Safety Modernization Act (FSMA) that proposes to make certain changes to the definition of the term “farm” in 21 CFR 1.227.  
The new question and answer explains FDA’s policy regarding food facility registration for farms that also pack or hold raw agricultural commodities grown on a farm under different ownership and that would no longer be required to register if the proposed amendments to the “farm” definition are finalized as proposed in the rulemaking. Under this policy, as discussed in the guidance, FDA does not intend to prioritize enforcing the registration requirement for such establishments.  This policy is a less burdensome policy consistent with the public health.  FDA intends to make further updates to this guidance once certain FSMA rulemakings are final in order to make sure questions and answers, key terms, and definitions are consistent and accurate with regard to the registration of food facility requirements.
For more information:

MHRA : Company-led drug alert: Recivit Sublingual Tablets - Grünenthal Limited - CLDA (14)A/19...

Company-led recalls 18 November 2014

CLDA number: CLDA (14)A/19
MDR number: MDR 25-11/14
Company name: Grünenthal Limited
Product description: 
Recivit Sublingual Tablets:
133mcg                    PL 21727/0058
267mcg                    PL 21727/0059
400mcg                    PL 21727/0060
533mcg                    PL 21727/0061
800mcg                    PL 21727/0062
Batch number/ Expiry:
  • 133mcg: batch no 14628; exp 30/09/2016
  • 267mcg: batch no 14630; exp 31/10/2016
  • 400mcg: batch no 14632; exp 31/10/2016
  • 533mcg: batch no 15025; exp 31/10/2016
  • 800mcg: batch no 14636; exp 30/11/2016
Brief description of problem: 
Due to a manufacturing issue, there is a possibility that blisters from the above batches may contain missing and / or two tablets in a single blister cavity.
We understand that a very small number of packs from the affected batches have been distributed to the UK market.
Company contact for stock enquiries:
UDG customer service
Tel 01773 515171
Company contact for medical information enquiries:
Grünenthal Medical Information
Tel 0870 351 8960

USFDA Drug Safety : FDA reviews long-term antiplatelet therapy as preliminary trial data shows benefits but a higher risk of non-cardiovascular death

FDA is evaluating preliminary data from a clinical trial showing that treatment for 30 months with dual antiplatelet blood-thinning therapy decreased the risk of heart attacks and clot formation in stents, but there was an increased overall risk of death compared to 12 months of treatment. The clinical trial compared 30 months versus 12 months of treatment with dual antiplatelet therapy consisting of aspirin plus either clopidogrel (Plavix) or prasugrel (Effient), following implantation of drug-eluting coronary stents. These stents are small, medicine-coated tubes inserted into narrowed arteries in the heart to keep them open and maintain blood flow to the heart. Clopidogrel and prasugrel are important medicines used to prevent heart attacks, strokes, and other clot-related diseases.
FDA believes the benefits of clopidogrel (Plavix) and prasugrel (Effient) therapy continue to outweigh their potential risks when used for approved uses. Patients should not stop taking these drugs because doing so may result in an increased risk of heart attacks, blood clots, strokes, and other major cardiovascular problems. Health care professionals should not change the way they prescribe these drugs at this time.
The Dual Antiplatelet Therapy (DAPT) trial was published in the New England Journal of Medicine on November 16, 2014. FDA has not reviewed the trial results or reached any conclusions based on the findings from this clinical trial. We are communicating this safety information while we continue to evaluate the results from this trial and other available data. We will communicate our final conclusions and recommendations when our evaluation is complete.
For more information, please visit: Antiplatelet

Chaotic Labz Issues Voluntary Nationwide Recall of Mayhem Dietary Supplement Due to Undeclared Dexamethasone and Cyproheptadine

Chaotic Labz, Atkins, Arkansas, is voluntarily conducting a nationwide recall of Mayhem dietary supplement capsules, Lot #CLM061114 with an expiration date of 06/2016, to the user/consumer level. Mayhem’s intended use is as a bodybuilding supplement. FDA laboratory analysis found that Mayhem Dietary Supplement contains undeclared dexamethasone, a prescription corticosteroid commonly used to treat inflammatory conditions, and cyproheptadine, a prescription antihistamine used for seasonal allergy treatment, making this an unapproved drug.
Consumers are advised that corticosteroid use can impair a person’s ability to fight infections, cause high blood sugar levels, muscle injuries and psychiatric problems. When corticosteroids are taken for a prolonged period, or at high doses, they can suppress the adrenal gland and cause withdrawal symptoms with abrupt discontinuation. Antihistamines may cause drowsiness and affect mental alertness. In addition, these undeclared drug ingredients in Mayhem may cause serious side effects when combined with other medications. To date, Chaotic Labz has not received reports of these adverse effects related to this recall.
Mayhem is packaged in a clear bottle with yellow capsules associated with Lot #CLM061114 with an expiration date of 06/2016. The product can be identified by the brand known as Chaotic Labz and product name Mayhem, Appetite for Construction. This product was distributed nationwide to various Nutritional Supplement Retail Outlets and via the internet.
Chaotic Labz is notifying its distributors and customers by a formal recall notification and arranging for a return of all recalled products. Distribution of Mayhem will also be halted. Consumers, Distributors, and Retailers that have any of the recalled product should STOP USING and return immediately to the place of purchase. Contact your health care professional if you have experienced any adverse effects.
For more information CLICK HERE

Health Canada Recall Alert - Dangers of Swallowing Small Magnetic Parts from Mega Brands Magnetix Magnetic Building Sets


Health Canada is alerting the public to the danger to children of all ages posed by toys with small, powerful magnets or certain toys with small powerful magnetic parts. When more than one powerful magnet is swallowed in a short period of time, the magnets can attract one another while moving through the intestines. This can cause the intestines to twist, creating blockages or tearing of the intestinal walls. The results of swallowing small powerful magnets can be very serious and life-threatening. Swallowing incidents have often resulted in considerable damage to the gastrointestinal tissues and required emergency surgical treatment. For survivors, there can be serious lifelong health problems.
Health Canada recently received an incident report involving a three year old child who swallowed two magnetic parts (2.7 cm long rods) from a Mega Brands Magnetix Magnetic Building Set. The child received swift medical attention and sustained no injury.

Products affected:

Mega Brands Magnetix Magnetic Building Sets, sold in Canada from 2006 to 2009.
887,000 units from over 100 different Magnetix sets were sold in Canada. They contained up to 350 plastic building pieces in an assortment of colours (primary) and finishes (metallic, translucent and glow in the dark). The building pieces included 2.54 cm triangles, cylinder rods, flexors and curves, as well as 1.25 cm diameter steel balls.
Due to numerous serious injuries requiring emergency medical treatment, and one fatality in the United States in 2005, Magnetix Magnetic Building Sets sold before April 2006 were recalled in Canada in 2007. For these toys the small, powerful magnets were prone to separate from their plastic parts. Both younger and older children were involved in swallowing incidents. Mega Brands redesigned their Magnetix magnetic building parts so that the small, powerful magnets were more securely attached. Building sets with these modified parts were sold in Canada from April 2006 to March 2009. Even though the small magnets were no longer detaching during play, many of the magnetic building parts in these sets were small enough to be swallowed by a child, as was the case in the recent incident where two rods were swallowed.
At the time these products were originally sold, they met the relevant requirements for safety; however, those requirements have evolved. Today, certain toys with powerful magnets are considered a serious danger to children of all ages. These toys have powerful magnetic parts that are small enough to be swallowed or have small, powerful magnets that separate from parts.

What you should do

Consumers should immediately and safely discard all Mega Brands Magnetix Magnetic Building Sets. They are also reminded to discard any older-style Magnetix magnetic toys that were recalled in 2007. The toys should be disposed of in normal household garbage in such a way that they cannot be used or re-sold. Please note that the Canada Consumer Product Safety Act prohibits recalled products from being redistributed, sold or even given away in Canada.

USFDA: New and Generic Drug Approvals: 05 NOV 2014

New and Generic Drug Approvals

November 5, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Cerdelga eliglustat tartrate Capsule;Oral Genzyme Corp Manufacturing Change or Addition
Cyramza ramucirumab Injectable;Injection Eli Lilly and Co Efficacy Supplement with Clinical Data to Support
Levoxyl levothyroxine sodium Tablet;Oral King Pharms R and D Manufacturing Change or Addition
Lopid gemfibrozil Capsule;Oral Pfizer Pharms Labeling Revision
Lopid gemfibrozil Tablet;Oral Pfizer Pharms Labeling Revision
Olysio simeprevir sodium Capsule;Oral Janssen Prods Efficacy Supplement with Clinical Data to Support
Pennsaid diclofenac sodium Solution;Topical Mallinckrodt Inc Labeling Revision
Protonix Iv pantoprazole sodium Injectable;Iv (Infusion) Wyeth Pharms Inc Manufacturing Change or Addition
Seasonale ethinyl estradiol; levonorgestrel Tablet;Oral Teva Branded Pharm Manufacturing Change or Addition
Zithromax azithromycin For Suspension;Oral Pfizer Manufacturing Change or Addition

Health Canada Product Withdrawal : Gra-MaxX Gold: Seized from "ShopForYou", Vancouver, B.C. due to serious safety risks

An unauthorized health product, Gra-MaxX Gold, was seized by Health Canada as it contains an undeclared drug: N-Ethyl Tadalafil. The product is used to treat erectile dysfunction. The product was tested by Health Canada and removed from sale from ShopForYou, Robson Street, Vancouver, B.C. This product may pose serious risks to the health of Canadians, especially individuals with heart problems.

Products affected

Gra-MaxX Gold.

What you should do

  • Consult with your doctor if you have used this product.
  • Read the label of the products you buy to verify that they have been assessed by Health Canada for safety, effectiveness and quality. Health products that have been authorized for sale by Health Canada will have an eight-digit Drug Identification Number (DIN), a Homeopathic Medicine Number (DIN-HM) or a Natural Product Number (NPN) on the label.
  • Report any adverse events to Health Canada.

    Who is affected

  • Consumers who have used or purchased Gra-MaxX Gold.


    Tadalafil should only be used under the supervision of a health care practitioner. Products containing tadalafil or its analogs should never be used by individuals taking any kind of nitrate drug (e.g. nitroglycerine) as it can cause potentially life-threatening low blood pressure.
    Individuals with heart problems including high blood pressure, a history of heart attack, stroke, abnormal heart beat or chest pain are at higher risk of cardiovascular side-effects if they engage in sexual activity, especially if they use tadalafil to help them achieve an erection. Other possible side-effects of using tadalafil include headache, facial flushing, indigestion, dizziness, abnormal vision and hearing loss.
    Caffeine was also found in the product and was not listed on the product label. Caffeine may pose health risks to people sensitive to its effects.