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news.Mylan Technologies, a subsidiary of Mylan, has obtained FDA's final approval for its abbreviated new drug application (ANDA) for Clonidine Transdermal System USP, 0.1mg/day, 0.2mg/day and 0.3mg/day, the generic version of Boehringer Ingelheim's Catapres-TTS(R), for hypertension treatment.
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Clonidine is a centrally acting alpha-agonist hypotensive agent. Mylan has stated that Clonidine stimulates alpha-adrenoreceptors in the brain stem.
The action results in reduced sympathetic outflow from the central nervous system and in decreases in peripheral resistance, renal vascular resistance, heart rate, and blood pressure.
Catapres-TTS is a transdermal system providing continuous systemic delivery of clonidine for 7 days at an approximately constant rate. Catapres-TTS transdermal therapeutic system is a multi-layered film, 0.2 mm thick, containing clonidine as the active agent.
Mylan is a generic and specialty pharmaceutical company and provides products to customers in more than 140 countries and territories. It has currently 132 ANDAs pending FDA approval.