Express Pharma

Sun Pharma announces US FDA approval for generic Mesalamine Extended Release capsules

The generic product approval is based on Pentasa Extended Release Capsules, 500 mg as a reference product, the statement added

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Sun Pharma yesterday announced that it has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for generic Mesalamine Extended Release Capsules, 500 mg, a company statement said.

The generic product approval is based on Pentasa Extended Release Capsules, 500mg as a reference product, the statement added.

As per March 2022 IQVIA Health data, Pentasa Extended Release Capsules, 500 mg had annualised
sales of approximately $213 million in the US, concluded the statement.

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