Mylan Launches Generic FazaClo

Mylan has announced the US launch of clozapine orally disintegrating tablets, 25 mg and 100 mg, the generic version of Jazz Pharmaceutical’s FazaClo.

Mylan recently received final approval from the FDA for its abbreviated new drug application (ANDA) for the tablets, which can be used to treat patients with schizophrenia who fail to respond to standard antipsychotic treatment.

Jazz Pharmaceutical’s product had US sales of $51 million for the fiscal year ending on September 30, 2015, according to IMS Health.

The FDA recently extended the pharmacy certification deadline for the clozapine risk evaluation and mitigation strategy (REMS) program due to implementation challenges. The deadline had been set for December 14, 2015, for pharmacists. The FDA has not yet stated the new deadline.

Adverse effects associated with clozapine include increased heart rate, low blood pressure, constipation, dizziness, and increased salivation.

Mylan has 272 pending ANDAs with the FDA, according to IMS Health. These ANDAs represent approximately $101 billion in potential annual sales.