Last Updated on December 31, 2023 by The Health Master
Bengaluru: The U.S. Food and Drug Administration (USFDA) 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 per cent to $2.7 in choppy after-market trading.
The USFDA 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.
Next 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 per cent 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.
USFDA declines to approve this Hormone Disorder therapy
USFDA declines to approve this Lung Cancer drug
USFDA declines to approve expanded use of this Antipsychotic drug
USFDA declines to approve this Urinary Tract Infection Drug
USFDA declines to approve this Anti-seizure drug
USFDA declines to authorise this viral skin disease treatment
USFDA gives tentative nod for Dolutegravir tablets for oral suspension
USFDA issues Form 483 with one observation to Gland Pharma: Hyderabad
USFDA approves 1st OTC Daily Oral Contraceptive
Drug recall: Dronabinol Capsules, Ziprasidone HCL Capsules recalled due to this reason
Pharma Companies challenge Govt’s Ban on Pre-1988 FDCs
India Pharma Industry is leading market for USFDA Authorizations
USFDA issues Form 483 to Lupin with 2 observations: Nagpur
USFDA issues EIR to Lupin for Pithampur unit-2
USFDA gives nod for Sevelamer HCL tablets
Govt to establish recruitment Rules for Medical Device Officers
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon: