The company secured final approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for this product, which is indicated to treat ADHD as monotherapy and as adjunctive therapy to stimulant medications.
According to IMS Health, Guanfacine extended-release tablets had US sales of $804.9m for the 12 months ending 31 March 2015.
Around 271 of Mylan ANDAs that represent $106bn in annual sales are still awaiting clearances from the FDA, with 47 of them being potential first-to-file opportunities, signifying $32bn in annual brand sales, for the year ending 31 December 2014.
Mylan offers a portfolio of more than 1,400 generic medications. The company provides a range of antiretroviral therapies to around 40% of HIV/AIDS patients in developing countries. It currently markets products in about 145 countries.