Industry Briefs

Zydus Recalls 35 Lots of Venlafaxine

Last month Zydus Pharmaceuticals voluntary recalled 35 lots of its antidepressant venlafaxine HCl ER 75 mg and 150 mg capsules—a generic version of Effexor XR. The recall includes all 30- , 90- , and 1,000- count bottles with expiration dates from September 2017 to December 2017.

The recall was issued after tests revealed the medication has marginally higher dissolution rates than normal at different time points, which the company said poses a minimal risk to patients.

Zydus recommends that anyone with the affected lots discontinue the use, dispensing, and distribution of the product immediately.

FDA Advisory Panel Recommends Approval of Psoriasis Drug, But With Black-Box Warning

Valeant Pharmaceuticals announced last month that a Food and Drug Administration (FDA) advisory panel recommended the approval of brodalumab for the treatment of moderate to severe plaque psoriasis despite several reports of suicidal ideation and behaviors by patients taking the medication.

Evidence presented to the panel shows 18 of the approximately 4,500 patients enrolled in clinical trials of the medication reported suicidal thoughts, eight patients attempted suicide, and six died by suicide.

While all of the 18 committee members voted in favor of the FDA’s approval of the medication, 14 also voted that additional risk-management options for suicidal ideation be implemented, FierceBiotechreports. ■