Generic Product News: April 2022

Pharmacy Times, April 2022, Volume 88, Issue 4

This month's generic product new features dexmethylphenidate, colchicine, and clarithromycin.

Dexmethylphenidate Capsules

Marketed by Camber

Compare To: Focalin

Camber has launched dexmethylphenidate capsulesin 5-, 10-, 15-, 20-, 25-, 30-, 35-, and 40-mg strengths, with all strengths available in 100-count bottles. The FDA has approved the extended-release capsules for the treatment of attention-deficit/hyperactivity disorder (ADHD). Dexmethylphenidate is a central nervous system stimulant. The drug aims to decrease hyperactivity and impulsiveness and increase attention for individuals with ADHD. Adverse events (AEs) can include anxiety, dry mouth, dyspepsia, headaches, and pharyngolaryngeal pain. For children aged 6 to 17 years, AEs can include anxiety, decreased appetite, dyspepsia, and headaches.

FOR MORE INFORMATION:

camberpharma.com

Colchicine Tablets

Marketed by Aurobindo Pharma

Compare To: Colcrys

The FDA has approved an abbreviated new drug application for Aurobindo Pharma’s colchicine tablets. The 0.6-mg tablets are a generic equivalent to the reference listed drug, Colcrys, by Takeda Pharmaceuticals. The FDA indicated the generic drug for the treatment of familial Mediterranean fever (FMF) in individuals 4 years or older. According to the National Institutes of Health, FMF is characterized by recurrent episodes of inflammation in the abdomen, chest, or joints, often accompanied by fever, headaches, and rash. Occasionally, inflammation can occur in other parts of the body, such as the heart and membranes around the brain and spinal cord.

FOR MORE INFORMATION:

aurobindousa.com

Vigabatrin Tablets

Marketed by Zydus

Compare To: Sabril

Zydus has received final approval to market vigabatrin tablets at the 500- mg strength as a generic for Sabril tablets. Vigabatrin is indicated to treat infantile spasms in children between aged 1 month and 2 years old. It is also indicated for use in combination with other medications to treat seizure disorders like epilepsy. The drug has helped decrease the number of seizures in adults and children who have not been able to control their seizures with other treatments. Vigabatrin is an anticonvulsant that works by stopping the breakdown of a naturally calming substance in the brain called gamma-aminobutyric acid.

FOR MORE INFORMATION:

zyduscadila.com

Clarithromycin

Marketed by Alembic Pharmaceuticals

Compare To: Biaxin Filmtab

The FDA has approved an abbreviated new drug application for clarithromycin tablets from Alembic Pharmaceuticals in the 250- and 500-mg strengths. The tablets are a generic for Biaxin Filmtab in the same strengths from AbbVie. Clarithromycin tablets are a macrolide antimicrobial indicated for mild to moderate infections caused by acute exacerbation of chronic bronchitis in adults. Additionally, they are indicated for acute maxillary sinusitis, community-acquired pneumonia, pharyngitis, tonsillitis, uncomplicated skin and skin structured infections, and other infections. The estimated market size for the tablets is $11 million for 12 months, according to a company statement.

FOR MORE INFORMATION:

alembicpharmaceuticals.com