Once-Daily Antidepressant Now Available in the US

Pam Harrison

October 10, 2012

October 10, 2012 — Forfivo XL (Edgemont Pharmaceuticals), a new extended-release formulation of bupropion hydrochloride, has recently become available in the United States for the treatment of major depressive disorders.

Edgemont Pharmaceuticals announced that Forfivo XL is now available in a 450-mg-dose single tablet for the treatment of major depressive disorder. The drug was approved by the US Food and Drug Administration in November 2011.

According to the company, it is the only extended-release bupropion product that is available as a once-daily, 450-mg-dose tablet.

The announcement comes shortly after the FDA announced that Budeprion XL 300 mg, one of several generic formulations of extended-release bupropion hydrochloride, was not therapeutically equivalent to Wellbutrin XL 300 mg, the brand-name extended-release formulation,.

"Until now, most patients in the US requiring a 450-mg dose of bupropion have been taking multiple tablets to achieve their dose requirement," Douglas Saltel, president and CEO of Edgemont Pharmaceuticals, in Austin, Texas, said in a press release.

"We are very pleased to be able to simplify the dosing regimen for these patients."

Full prescribing information is available at www.forfivoxl.com.

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