Rx Product News: January 2022

Amphetamine (Dyanavel XR)

Manufactured by Tris Pharma

The FDA has approved Dyanavel XR, an amphetamine extended-release (ER), once- daily tablet for the treatment of individuals aged 6 years and older with attention- deficit/hyperactivity disorder (ADHD). In a clinical study of healthy individuals aged 6 years and older, the tablets were deemed to be bioequivalent to amphetamine ER oral suspension. The oral suspension appeared to improve ADHD symptoms as soon as 30 minutes after dosing.

FOR MORE INFORMATION:

trispharma.com

Repository Corticotropin Injection (Purified Cortrophin Gel)

Manufactured by ANI Pharmaceuticals

The repository corticotropin injection is for the treatment of chronic autoimmune disorders, including acute exacerbations of multiple sclerosis and rheumatoid arthritis. It can also help decrease excess urinary protein, due to nephrotic syndrome. The injection is an adrenocorticotropic hormone known as purified corticotropin.

FOR MORE INFORMATION:

anipharmaceuticals.com

Pilocarpine HCI Ophthalmic Solution (Vuity)

Manufactured by AbbVie

The FDA has approved pilocarpine HCI ophthalmic solution 1.25% for the treatment of presbyopia, or age- related blurry near vision, in adults. It is the first and only FDA-approved eye drop for this condition, according to AbbVie. Improvements to near vision in low light conditions without loss of distance vision were seen as early as 15 minutes and lasted through 6 hours. There were no serious adverse events recorded in the clinical trial.

FOR MORE INFORMATION:

abbvie.com

Asciminib (Scemblix)

Manufactured by Novartis

Asciminib was approved for the treatment of individuals with Philadelphia chromosome (Ph)-positive chronic myeloid leukemia (CML) in chronic phase who were administered 2 or more tyrosine kinase inhibitors. It was also approved for use in individuals with Ph-positive CML in chronic phase with a T315I mutation. The clinical trials showed that asciminib had a molecular response rate of 25% at the 24-week mark.

FOR MORE INFORMATION:

novartis.com