Sun Pharmaceutical Industries Limited, announced that it has received final approval from US FDA for its Abbreviated New Drug Application (ANDA) for generic Mesalamine Extended Release Capsules, 500 mg.
The generic product approval is based on Pentasa® Extended Release Capsules, 500mg as a reference product. As per March 2022 IQVIA Health data, Pentasa® Extended Release Capsules, 500mg had annualized sales of approximately US$ 213 million in USA.
Shares of Sun Pharmaceutical Industries NSE 4.26 % jumped 4.3 per cent in early trade on Friday after the drugmaker said that it received final approval from the US health regulator for Mesalamine extended release capsules, in the American market.
Sun Pharmaceutical’s scrip rose to a high of Rs 886.60 as against Rs 850.15 at the previous close on the BSE.