• Investing
  • Stock
Round Table Thoughts
  • Economy
  • Editor’s Pick
Home Economy FDA declines approval for Amneal Pharmaceuticals’ Parkinson’s drug
Economy

FDA declines approval for Amneal Pharmaceuticals’ Parkinson’s drug

by July 4, 2023
by July 4, 2023 0 comment
Share
0
FacebookTwitterPinterestWhatsapp

The U.S. Food and Drug Administration (FDA) has declined to approve Amneal Pharmaceuticals’ drug for Parkinson’s disease due to inadequate safety data on the treatment to help control symptoms in patients for a longer duration, the company said on Monday.

Shares of Amneal Pharmaceuticals fell 13.1% to $2.7 in choppy after-market trading.

The FDA in a complete response letter said while the company established the safety of one ingredient, levodopa, based on some studies, it was not able to adequately establish safety for the other ingredient, carbidopa.

The health regulator has requested additional information on the safety of the drug, while it did not identify any efficacy or manufacturing issues with the drug.

Amneal’s drug is a new formulation of carbidopa-levodopa, the standard of care for Parkinson’s, and is designed in a way that allows it to remain in a certain area of the small intestine for a longer period, helping in its consistent absorption.

The company said it will work closely with the health regulator to address the issues and plans to meet with the agency.

The health regulator’s decision is a potential hurdle to the company, which has been looking to grow its portfolio of branded drugs, expecting over $500 million in revenues from its specialty business by 2027.

The drugmaker said the decision does not impact its 2023 financial forecast as it did not include the revenue from the drug.

Amneal currently has another Parkinson’s drug, Rytary, which was approved in 2015 in the market but had been struggling to gain a foothold in the treatment space, with only 4% of patients using it.

Parkinson’s is a brain disorder that causes unintended or uncontrollable movements and is the second most-deadly neurodegenerative disease after Alzheimer’s. There is no cure for Parkinson’s currently, but medicines and other therapies can help relieve symptoms.

<!–>

This post appeared first on FOX NEWS

–>

You Might Also Like
  • Oklahoma board approves nation’s first taxpayer-funded religious school
  • White House ‘grateful’ to Mexico for agreeing to help with feared post-Title 42 migrant surge
  • Ticketmaster’s day in Congress met with bipartisan ‘bad blood’ and more Taylor Swift puns from senators
  • Defiant fisherman tells Chinese coast guard to ‘go away’ from disputed territory amid rising tensions
Share
0
FacebookTwitterPinterestWhatsapp

previous post
Williamson torches DNC’s ‘outrageous’ support for Biden in 2024 Dem primary
next post
Georgia universities spent millions on DEI efforts prior to state budget cuts: Report

You may also like

2024 Watch: Tim Scott laying out $8 million to run...

August 17, 2023

St. Louis mayor’s gun control stance questioned after private texts...

July 12, 2023

Biden quietly places unconfirmed labor secretary in presidential line of...

October 19, 2023

Ohio Republican lawmakers push for revised school voucher program

June 2, 2023

Trump’s loan proposal for Ukraine aid may be common ground...

April 16, 2024

Tech Regulations: The EU regulates, the US steps back

October 8, 2024

Dogecoin and Shiba Inu: Doge continues on the positive side

September 13, 2024

Hunter Biden’s daughter with ex-stripper will receive some of his...

June 30, 2023

Dem lawmakers struggle to deal with fallout of Biden debate...

June 28, 2024

Israel-Hamas war: Five American aid workers leave Gaza for Egypt...

November 2, 2023

    Stay updated with the latest news, exclusive offers, and special promotions. Sign up now and be the first to know! As a member, you'll receive curated content, insider tips, and invitations to exclusive events. Don't miss out on being part of something special.


    By opting in you agree to receive emails from us and our affiliates. Your information is secure and your privacy is protected.

    Recent Posts

    • Week Ahead: NIFTY Stays In A Defined Range; Moving Past This Level Crucial For Resumption Of Upmove

      May 31, 2025
    • Breakouts, Momentum & Moving Averages: 10 Must-See Stock Charts Right Now

      May 31, 2025
    • Leadership Rotation Could Confirm Corrective Phase

      May 30, 2025
    • Run Your Stock Portfolio Like a Pro Sports Team

      May 30, 2025
    • U.S. foreign tax bill sends jitters across Wall Street

      May 30, 2025

    Popular Posts

    • 1

      Trump-era China sanctions ended by Biden may be...

      June 27, 2024 2,765 views
    • 2

      Walz’s honeymoon with China gets fresh scrutiny as...

      August 9, 2024 2,472 views
    • 3

      Biden appointee played key role in recruiting Chinese...

      June 25, 2024 2,451 views
    • 4

      Shein’s global ambitions leaves some cybersecurity experts fearful...

      July 10, 2024 2,432 views
    • 5

      Harris VP pick spent years promoting research facility...

      August 29, 2024 2,309 views

    Categories

    • Economy (7,009)
    • Editor's Pick (2,106)
    • Investing (538)
    • Stock (2,582)

    Popular Posts

    • 1

      Trump-era China sanctions ended by Biden may be revived under new House GOP bill

      June 27, 2024
    • 2

      Walz’s honeymoon with China gets fresh scrutiny as Harris camp blasts ‘lying’ critics

      August 9, 2024
    • 3

      Biden appointee played key role in recruiting Chinese businesses to Delaware: ‘Longtime friends’

      June 25, 2024
    • 4

      Shein’s global ambitions leaves some cybersecurity experts fearful of Chinese spy threats

      July 10, 2024
    • 5

      Harris VP pick spent years promoting research facility that collaborated with ‘Chinese military company’

      August 29, 2024

    Latest News

    • Week Ahead: NIFTY Stays In A Defined Range; Moving Past...

      May 31, 2025
    • Breakouts, Momentum & Moving Averages: 10 Must-See Stock Charts Right...

      May 31, 2025
    • Leadership Rotation Could Confirm Corrective Phase

      May 30, 2025

    Categories

    • Economy (7,009)
    • Editor's Pick (2,106)
    • Investing (538)
    • Stock (2,582)

    Disclaimer: RoundTableThoughts.com, its managers, its employees, and assigns (collectively “The Company”) do not make any guarantee or warranty about what is advertised above. Information provided by this website is for research purposes only and should not be considered as personalized financial advice. The Company is not affiliated with, nor does it receive compensation from, any specific security. The Company is not registered or licensed by any governing body in any jurisdiction to give investing advice or provide investment recommendation. Any investments recommended here should be taken into consideration only after consulting with your investment advisor and after reviewing the prospectus or financial statements of the company.

    Copyright © 2024 RoundTableThoughts.com. All Rights Reserved.

    Round Table Thoughts
    • Investing
    • Stock
    Round Table Thoughts
    • Economy
    • Editor’s Pick

    Read alsox

    Alabama Gov. Kay Ivey sworn in...

    January 16, 2023

    SEE IT: Biden continues building taxpayer-funded...

    January 16, 2023

    Special Counsel Jack Smith asks SCOTUS...

    February 15, 2024
    Sign In

    Keep me signed in until I sign out

    Forgot your password?

    Password Recovery

    A new password will be emailed to you.

    Have received a new password? Login here