USFDA approves Drug to treat Hyperactivity disorder

The most common adverse events were insomnia, dry mouth, headache, irritability, nausea, and dizziness.

82
USFDA
Picture: Pixabay

Last Updated on November 8, 2021 by The Health Master

The USFDA has approved amphetamine (Dyanavel XR, Tris Pharma) extended-release once daily tablet, for the treatment of individuals 6 years of age or older with attention-deficit hyperactivity disorder (ADHD).

“The approval of Dyanavel XR tablets, which use Tris’ LiquiXR technology platform, fills an important gap in Tris’ portfolio of ADHD products to fit the needs of a variety of patient types.

Dyanavel XR oral suspension and now Dyanavel XR tablets provide a unique pharmacokinetic profile and a broad range of dosing options for patients needing an amphetamine for their ADHD,” said James Hackworth, PhD, president of the Tris Pharma Branded Products Division, in a press release.

In a clinical study of healthy adults, Dyanavel XR tablets were deemed to be bioequivalent to amphetamine extended-release oral suspension.

The oral suspension demonstrated improvements of ADHD symptoms in children 6 to 12 years of age within an hour and lasted through 13 hours after once-daily dosing, according to Tris Pharma. In another study, the amphetamine oral suspension appeared to improve ADHD symptoms as soon as 30 minutes after dosing.

In a separate study, Dyanavel XR tablets demonstrated statistically significant improvements compared to placebo in mean Permanent Product Measure of Performance Total.

The most common adverse events were insomnia, dry mouth, headache, irritability, nausea, and dizziness.

Dyanavel XR tablets are expected to be available in pharmacies in the first quarter of 2022.

Reference

Tris Pharma announces USFDA approval of DYANAVEL XR (amphetamine) once-daily extended-release oral tablets, CII, for ADHD. Email. News release. November 5, 2021. Accessed November 5, 2021.

USFDA’s nod for Kerala’s local herb Manathakkali for Liver Cancer Treatment

USFDA nod for Cortrophin Gel to treat Autoimmune Disorders

Allergan gets USFDA nod for eye drop to treat blurry vision

Novartis gets USFDA approval for drug to treat Chronic Leukemia

Aurobindo Pharma gets USFDA nod for cancer treatment drug

USFDA approves drug for severe Itching in kidney disease patients

Latest on National Pharmaceutical Pricing Authority (NPPA)

Counselling for admission to MBBS courses to begin soon

USFDA’s nod for Kerala’s local herb Manathakkali for Liver Cancer Treatment

Govt not to impose anti-dumping duty on Vitamin C

Explained: What is oral antiviral drug Molnupiravir ?

Gujarat FDCA issues huge number of Product Permissions

Artificial Intelligence will be used to discover New Drugs: Google

Govt Job for Drug Inspector, Assistant Drug Inspector

Duties of Retail Chemists / Medical Store / Pharmacy

Latest Notifications regarding Pharmaceuticals

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

YouTube Icon
Telegram
WhatsApp
Facebook
LinkedIn
YouTube Icon
Google-news

Enter your email address:

Delivered by FeedBurner