November 30, 2015
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Mylan releases generic FazaClo orally disintegrating tablets
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Mylan recently announced the launch of clozapine orally disintegrating tablets, the generic version of Jazz Pharmaceuticals’ FazaClo, according to a company press release.
Mylan received final FDA-approval for its Abbreviated New Drug Application for 25-mg and 100-mg clozapine tablets, which are indicated for patients with schizophrenia who fail to respond to standard antipsychotic treatment.
As of Sept. 30, 25-mg and 100-mg doses of clozapine orally disintegrating tablets had U.S. sales of approximately $51.1 million for the past 12 months, according to IMS Health.
Further, IMS Health reported that Mylan currently has 272 Abbreviated New Drug Applications pending FDA approval, representing $101.8 billion in annual brand sales.