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Shilpa Medicare Ltd receives US FDA tentative approval for Apremilast Tablets, 10 Mg, 20 Mg, And 30 Mg

Posted On: 2021-03-04 22:35:24 (Time Zone: Arizona, USA)


Shilpa Medicare Ltd has received U.S Food and Drug Administration tentative approval for its ANDA, Apremilast Tablets, 10 mg, 20 mg, and 30 mg dated 04 Mar 2021. The ANDA was filed as 'First to File' submission on NCE -1 date to seek eligibility for 180 days exclusivity.

Apremilast Tablets, 10 mg, 20 mg, and 30 mg is a generic equivalent of reference listed drug (RLD) OTEZLA of Celgene used in the treatment of 'psoriatic arthritis' as recommended in the label approved by FDA.

According to IQVIA MAT Q2 2020 data, the US market for Apremilast Tablets, 10 mg, 20 mg, and 30 mg is approximately US $2.4 billion.

Shares of SHILPA MEDICARE LTD. was last trading in BSE at Rs.385 as compared to the previous close of Rs. 369. The total number of shares traded during the day was 75357 in over 2791 trades.

The stock hit an intraday high of Rs. 392.75 and intraday low of 368. The net turnover during the day was Rs. 28848373.


Source: Equity Bulls

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