Par Pharmaceutical Companies has announced that its licensing partner, Aveva Drug Delivery Systems, has received final approval from the US Food and Drug Administration for its abbreviated new drug application for a clonidine transdermal system.
Clonidine TDS is a generic version of Boehringer Ingelheim’s Catapres TTS® and is the first generic seven-day patch indicated in the treatment of hypertension. Clonidine TDS is available in 0.1 mg/day, 0.2 mg/day and 0.3 mg/day strengths. Annual US sales of Catapres TTS were approximately $297 million, according to IMS Health data. Par will begin shipping clonidine TDS to the trade in the near future.
Paul V. Campanelli, president of Par’s generic division, said, “We are very pleased to have received this critical approval. Par and Aveva have been working together tirelessly to bring this important product to market.”
“We appreciate Par’s support and commitment throughout the development effort and the extended approval process of this important first generic product,” stated Wallace Reams, president and chief operating officer of Aveva Drug Delivery Systems.
Under the terms of its agreement with Aveva, Par has exclusive rights to market, sell and distribute Aveva’s clonidine TDS in the US. The product will be manufactured by Aveva, and the companies will share profits from the sales of the product.
Important information about clonidine TDS
The clonidine transdermal system is indicated in the treatment of hypertension. It may be employed alone or concomitantly with other anti-hypertensive agents. The clonidine transdermal system should not be used in patients with known hypersensitivity to clonidine or to any other component of the transdermal system.