Capital Wired

Keeps You Updated

Friday, April 16, 2021
Log in
  • Headlines
  • Business
  • Health
  • Tech & Science
  • Sports
  • World
  • US
  • Latest News
    • How To Make Your Own Home-Brewed Morphine
    • Using Mouthwash Too Often Puts You at Risk of Obesity and Diabetes
    • Walmart to Solve its Supply Chain Issues and Further Cut Down on Costs
    • The World’s Most Expensive Christmas Decorations
    • Netflix Hopes to Balance Data Limit With Great Video Quality
    • Joji Morishita says Japan Will Resume Whaling
    • The Most Beloved Plastic Surgeries Among Americans
    • Skype for Web Allows Non-Users to Take Part In Its Online Chats

Pages

  • About Capital Wired
  • Contact Us
  • Privacy Policy GDPR
  • Reprint & Licensing
  • Staff
  • Terms of Use

Recent Posts

  • Here’s Why Your Brain Keeps Worrying about Everything June 29, 2018
  • Don’t Throw That Sunscreen after Summer Is Up June 29, 2018
  • Analysts: Currency War between U.S. and China Might Be Looming June 28, 2018
  • Starbucks Rival The Coffee Bean & Tea Leaf Opening 100 Shops June 27, 2018
  • Study Finds We Are Alone in the Universe June 26, 2018
  • Restaurant Owner Not Sorry for Booting Sarah Sanders June 26, 2018
  • Beware of the Hidden Salt in Your Food! June 25, 2018

FDA’s Advisory Committee Approves Actavis (ACT) Anti-Biotic

December 6, 2014 By Germaine Hicks 2 Comments

Email, RSS Follow

fda-actavis-antibiotic

Recently, Actavis plc (Nyse:act) declared that its trail anti-biotic, ceftazidime-avibactam, has been prescribed by the US Food & Drug Administration’s (FDA) Anti-Infective Drugs Advisory Committee, for treating intricate intra-abdominal diseases (cIAI) and convoluted urinary tract diseases (cUTI) brought on by drug resistant bacteria.

Actavis is co-creating the medication with Astrazeneca plc (ADR) (Nyse:azn). According to the terms of the agreement, Actavis possesses the privileges of the medication in North America, though Astrazeneca holds the rights for it in other nations.

The advisory group’s verdict was focused around the drug’s guaranteeing Phase II clinical trials, which have built its worth and safety for treating hospital patients with cIAI or cUTI, when limited or no alternating treatment is accessible.

Though, the anti-biotic was not able to get the board of trustees’ sanction for treating patients with hospital-acquired bacterial pneumonia (HABP), ventilator-acquired bacterial pneumonia (VABP), and bacteremia. The panel was not persuaded of ceftazidime-avibactam’s efficiency focused around the clinical trials information accommodated for these signs. The advisory group was also cynical about controlling the anti-biotics to patients with renal impairment.

The committee’s proposal is not obligatory on the FDA, which has a definitive power in settling on a final decision for the drug’s endorsement. Though, the FDA does consider the Committee’s proposal and typically gives comparative options; it is predictable to make its decision with respect to Actavis’ ceftazidime-avibactam New Drug Application (NDA) in the first quarter of next year.

In March a year ago, the medication got qualified infectious disease product (QIDP) status from the FDA, which makes it entitled for FDA’s fast track program and 5 years marketing uniqueness. The project facilitates the improvement and administrative methodology of medications created to treat life-threatening ailments, for which none or just a couple of affirmed medicines are accessible.

In August, Actavis declared positive results from the drug’s Phase III trials, Reclaim-1 and Reclaim-2. The trials looked at ceftazidime-avibactam’s adequacy and safety with the medication meropenem, in patients with cIAIs. The results demonstrated the medication met the aim of non-inferior treatment in comparison with meropenem.

The suggestion for the medication by the Advisory Committee is uplifting news for Actavis, as it can build its incomes by advertising its medications for the suggested signs, if FDA supports the medication. There are around 300,000 cases of cIAI reported every year.

Email, RSS Follow

Germaine Hicks

Germaine is an avid sports fan and as such, he decided on his current career path with the idea in mind that he would never, ever miss a Yankee game. Until now, he managed to make good on that promise. As you’ve probably guessed, he’s our go-to sports guy.

Filed Under: Health Tagged With: ACT, Actavis, Advisory Committee, antibiotic, Astrazeneca plc (ADR), bacteremia, ceftazidime-avibactam, cIAI, cUTI, fda, hospital-acquired bacterial pneumonia (HABP), meropenem, ventilator-acquired bacterial pneumonia (VABP)

Subscribe to Blog via Email

Enter your email address to subscribe to this blog and receive notifications of new posts by email.

Recent Articles

dc logo on black galaxy background

Ava DuVernay to Direct DC’s New Gods Adaptation

March 16, 2018 By Rebecca McGhee Leave a Comment

leonardo davinci's signature in black

Is DaVinci’s Record Breaking Painting Authentic?

November 20, 2017 By Rebecca McGhee Leave a Comment

stephen hawking

Stephen Hawking Makes Gloomy Prediction For Earth In A 100 Years

May 7, 2017 By Deborah Nielsen Leave a Comment

"Dwayne Johnson not dead"

Dwayne Johnson Died this Week or Not

January 19, 2016 By Jason Leathers 3 Comments

There Are At Least Three More Seasons of Game of Thrones To Go

July 31, 2015 By Rebecca McGhee Leave a Comment

Homelessness Soars in L.A., Officials Pledge to House Everybody by 2016

May 12, 2015 By Brian Galloway Leave a Comment

FBI Releases National Report on Slain Police Officers, Figures are Alarming

May 12, 2015 By Rebecca McGhee Leave a Comment

New York Nuclear Plant Partially Shut Down due to Hudson Oil Slick

May 11, 2015 By Jason Leathers 2 Comments

Obama Draws Heat from Democrats over Asia Trade Deal

May 9, 2015 By Rebecca McGhee Leave a Comment

Florida Governor Changes Stance on Obamacare Once More, Budget on Hold

May 9, 2015 By Brian Galloway Leave a Comment

Secret Service to add an Extra Layer of Spikes to White House Fence

May 8, 2015 By Chen Lai Leave a Comment

Police Arrested Suspect in death of Student who tried to Sell Car on Craigslist

May 8, 2015 By Deborah Nielsen 1 Comment

AccuWeather.com: 2015 Atlantic Tropical Storm Season is Officially Open

May 7, 2015 By Deborah Nielsen Leave a Comment

Illinois Student Found Dead after Trying to Sell his Car on Craigslist

May 7, 2015 By Deborah Nielsen 2 Comments

Related Articles

  • Woman drinking coffee

    Here’s Why Your Brain Keeps Worrying about Everything

    Jun 29, 2018
  • Expiry date on sunscreen bottle

    Don’t Throw That Sunscreen after Summer Is Up

    Jun 29, 2018
  • U.S. President Donald Trump smiling

    Analysts: Currency War between U.S. and China Might Be Looming

    Jun 28, 2018
  • Kitchen salt

    Beware of the Hidden Salt in Your Food!

    Jun 25, 2018
  • Giant Hogweed

    Blindness-Causing Toxic Weed Spotted for the First Time in VA

    Jun 22, 2018
  • Pot leaves

    Pot Users More Sensitive to Pain (Study)

    Jun 22, 2018
  • Fasting diet

    16:8 Diet Can Help You Lose Weight without Hassle (Study)

    Jun 19, 2018
  • Mother and toddler

    Helicopter Parents Can Wreak Havoc on Kids’ Emotional Health, Study

    Jun 19, 2018
  • Young woman getting a tan

    Vitamin D Deficiency Tied to Higher Colon Cancer Risk

    Jun 15, 2018
  • Kitchen towels

    Kitchen Towels Are Breeding Grounds for Disease-Causing Bacteria, Study

    Jun 13, 2018

Categories

  • Business
  • Headlines
  • Health
  • Sports
  • Tech & Science
  • US
  • World

Copyright © 2021 capitalwired.com

About · Privacy Policy · Terms of Use · Contact