USFDA approves Intravenous therapy for hearing loss

This was Fennec's third attempt to secure approval for the intravenous treatment.

174
USFDA Approval
USFDA Approval

Last Updated on October 9, 2024 by The Health Master

The U.S. Food and Drug Administration (USFDA) has approved Fennec Pharmaceuticals Inc’s intravenous therapy to prevent chemotherapy-induced hearing loss in children, according to the health regulator’s website.

The approval, posted on the regulator’s website late Tuesday, for Pedmark allows it to be used to reduce the risk of ototoxicity in children aged over one month who have undergone chemotherapy using the drug cisplatin.

Cisplatin is used in treating a range of cancers in children such as liver, bone and brain cancer, but can cause permanent hearing loss.

Pedmark is now the only approved therapy to prevent cisplatin-induced hearing loss in the United States, with most patients opting for either cochlear implants or hearing aids.

The company’s shares closed nearly 16% higher on Tuesday.

This was Fennec’s third attempt to secure approval for the intravenous treatment.

The FDA had twice declined to approve the therapy citing some deficiencies at the company’s manufacturing facility.

According to Fennec, nearly 10,000 children in the U.S. and Europe receive chemotherapy with cisplatin or similar drugs each year, and the incidence of hearing loss depends on the duration and dosage of the therapy.

USFDA approves Terlipressin for injection to treat Kidney function

USFDA gives tentative approval for Sugammadex Injection

USFDA gives approval for Lenalidomide capsules

USFDA gives final approval for Cariprazine capsules

USFDA gives approval for this cancer drug

USFDA approves Venlafaxine, Pregabalin extended release tablets

Panel asks Govt to bring essential Medical Devices under NLEM

Govt constitutes committee to regulate Pharma Marketing Practices

NPPA extends ceiling price fixation on orthopaedic Knee Implants

USFDA regulator resumes surprise inspections of pharma units in India

After raids in Pune, FDA cancels production license of Johnson and ohnson’s baby powder unit

USFDA issues Form 483 to Indoco with zero observation

NPPA fixes Retail Prices of 37 Formulations: September 2022

High Court: Marketing Companies will have a right to the Trademark

Drug alert: 45 out of 1330 samples declared as NSQ in August 2022

Latest Notifications regarding Pharmaceuticals

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos by The Health Master, click on the below YouTube icon:

YouTube Icon

For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:

YouTube Icon

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos on consumer awareness, click on the below YouTube icon:

YouTube Icon
Telegram
WhatsApp
Facebook
LinkedIn
YouTube Icon
Google-news