FDA Approves Aveva Drug Delivery Systems To Market Clonidine TDS

Par Pharmaceutical has announced that its licensing partner, Aveva Drug Delivery Systems, has received final approval from FDA 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 0.1mg/day, 0.2mg/day and 0.3mg/day strengths. Par will begin shipping clonidine TDS to the trade in the near future.

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.

Paul Campanelli, president of generic division at Par, 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.

Wallace Reams, president and chief operating officer of Aveva Drug Delivery Systems, said: We appreciate Par’s support and commitment throughout the development effort and the extended approval process of this important first generic product.