FDA Approves Ajovy Injection Autoinjector
30 January 2020 - - The Food and Drug Administration has approved an autoinjector device for Ajovy (fremanezumab-vfrm) injection, Teva Pharmaceuticals USA, Inc. an affiliate of Israeli pharmaceutical company Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) (TASE: TEVA), said.

The Ajovy autoinjector is expected to be available to patients in the coming months.
US Important Safety Information about Ajovy (fremanezumab-vfrm) injection

Ajovy is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients.

Hypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria were reported with Ajovy in clinical trials.

Most reactions were mild to moderate, but some led to discontinuation or required corticosteroid treatment. Most reactions were reported from within hours to one month after administration.

The most common adverse reactions (≥5% and greater than placebo) were injection site reactions.

Teva Pharmaceutical is in generic and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area.