Teva Pharmaceuticals USA, Inc. issued the following announcement on Jan. 28.
Teva Pharmaceuticals USA, Inc. an affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the Food and Drug Administration (FDA) has approved an autoinjector device for AJOVY® (fremanezumab-vfrm) injection.
“The approval of the AJOVY autoinjector is another important step forward for Teva and the migraine community,” said Brendan O’Grady, executive Vice President, North America Commercial, Teva. “AJOVY is the only FDA-approved anti-CGRP that offers the flexibility of quarterly (675 mg) or monthly (225 mg) dosing options, and we are pleased that patients and their healthcare providers will be able to decide if an autoinjector is the right administration option for their needs.”
The AJOVY autoinjector is expected to be available to patients in the coming months.
U.S. Important Safety Information about AJOVY® (fremanezumab-vfrm) injection
Contraindications: AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients.
Hypersensitivity Reactions: 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. If a hypersensitivity reaction occurs, consider discontinuing AJOVY and institute appropriate therapy.
Adverse Reactions: The most common adverse reactions (≥5% and greater than placebo) were injection site reactions.
Please click here for full U.S. Prescribing Information for AJOVY® (fremanezumab-vfrm) injection.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at www.tevapharm.com.
Original source can be found here.