Mylan N.V. (Nasdaq: MYL) today announced the U.S. launch of Paliperidone Extended-Release Tablets 1.5 mg, 3 mg, 6 mg and 9 mg, the generic version of Janssen's Invega®. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the treatment of schizophrenia in adults and adolescents (12 – 17 years of age) in addition to schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressants in adults.
Paliperidone Extended-Release Tablets 1.5 mg, 3 mg, 6 mg and 9 mg, had U.S. sales of approximately $606.2 million for the 12 months ending June 30, 2015, according to IMS Health.
Currently, Mylan has 260 ANDAs pending FDA approval representing $98.7 billion in annual brand sales, according to IMS Health. Fifty of these pending ANDAs are potential first-to-file opportunities, representing $33.4 billion in annual brand sales, for the 12 months ending December 31, 2014, according to IMS Health.
SOURCE Mylan N.V.