FDA approves generic Comtan tablets for Parkinson's

June 29, 2015

FDA has approved Aurobindo’s entacapone tablets USP, 200 mg, the generic equivalent to Novartis’ Comtan tablets 200 mg.

FDA has approved Aurobindo’s entacapone tablets USP, 200 mg, the generic equivalent to Novartis’ Comtan tablets 200 mg.

Entacapone is a commonly used drug in the treatment of Parkinson’s disease, especially in moderate to advanced stages.

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Dr Hung“Taken with carbidopa/levodopa either as a separate pill or in combination, entacapone is effective in reducing ‘off’ time that can occur at later stages of disease,” Albert Hung, MD, director of the MGH National Parkinson Foundation Center of Excellence and assistant professor of neurology at Harvard Medical School, told FormularyWatch.

“Some patients may have difficulty obtaining entacapone due to cost; this approval will be a helpful step if it makes the medication more readily available, especially to those with less insurance coverage,” Dr Hung said.

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Formulary managers will need to consider whether to carry combined carbidopa/levodopa/entacapone (currently branded as Stalevo), which offers convenience to taking the medications separately, versus requiring separate prescriptions for generic carbidopa/levodopa and entacapone, according to Dr Hung.

“As entacapone is already clinically available and used regularly, this approval may not affect prescribing patterns as much as it will the way the formularies and pharmacies fill the prescription,” he said. “If this new generic formulation is equally effective to the current forms, the use is likely to depend more on pharmacy/insurance choices than on neurologists/physicians.”

Entacapone has an estimated market size of $59 million for the 12 months ending April 2015 according to IMS.

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