Mylan N.V. announced the U.S. launch of Clozapine Orally Disintegrating Tablets, 25 mg and 100 mg, the generic version of Jazz Pharmaceutical's FazaClo®. 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 used for the treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment.
Clozapine Orally Disintegrating Tablets, 25 mg and 100 mg, had U.S. sales of approximately $51.1 million for the 12 months ending Sept. 30, 2015, according to IMS Health.
Currently, Mylan has 272 ANDAs pending FDA approval representing $101.8 billion in annual brand sales, according to IMS Health. Fifty of these pending ANDAs are potential first-to-file opportunities, representing $36.1 billion in annual brand sales, for the 12 months ending June 30, 2015, according to IMS Health.
