FDA Approves Generic Depression Drug


Mylan launches desvenlafaxine extended-release tablets.

Last week, Mylan received FDA approval for desvenlafaxine extended-release tablets in 50-mg and 100-mg doses, which is a generic for Pfizer’s Pristiq tablets.

The FDA approved the abbreviated new drug application for desvenlafaxine to treat major depressive disorder, according to a press release.

An IMS Health report indicated that desvenlafaxine extended-release tablets had sales of $853 million for 2016. Launching the generic version of the drug will likely increase costs even further and improve patient access to pharmacotherapy for depression.

Since 2008, Pristiq has been prescribed to more than 2.5 million patients to treat depression. Clinical trials showed that Pristiq 50-mg improved patients’ ability to function at work, socially, and at home, according to Pfizer.

Common adverse events include nausea, dizziness, insomnia, hyperhidrosis, constipation, somnolence, decreased appetite, anxiety, and male sexual function disorders. Patients may also increase the risk of suicidal thinking and behavior in children, adolescents, and young adults.

Generic desvenlafaxine extended-release will likely increase access to drugs proven to improve depression symptoms. Due to lower costs, patients may be more likely to seek treatment with a generic, compared with the branded products.

A recent study found that while antidepressant use has increased in the country, healthcare professionals are still concerned that many adults with depression are not receiving adequate treatment. In some cases, adults receive treatment that does not match the severity of their disease or cannot afford their medications, which can result in non-adherence and disease progression.

This latest FDA approval has the potential to greatly improve treatment for patients with major depressive disorder.

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