Glenmark gets USFDA nod to market generic version of Otezla tablets
The company has received final approval from the US Food & Drug Administration (USFDA) for Apremilast tablets in strength of 10 mg, 20 mg and 30 mg, the Mumbai-based drug maker said in a statement.
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Glenmark Pharmaceuticals on Tuesday said it has received approval from the US health regulator to market a generic medication to treat psoriatic arthritis in the American market.
The company has received final approval from the US Food & Drug Administration (USFDA) for Apremilast tablets in strength of 10 mg, 20 mg and 30 mg, the Mumbai-based drug maker said in a statement.
The company's product is a generic version of Otezla tablets, it added.According to IQVIA sales data for the 12-month period ending August 2023, the Otezla tablets (10 mg, 20 mg, and 30 mg) achieved annual sales of around USD 3.7 billion.
Glenmark said its current portfolio consists of 188 products authorised for distribution in the US market marketplace and 50 abbreviated new drug applications (ANDAs) are pending approval with the USFDA.
Glenmark shares were trading 1.49 per cent up at Rs 809.40 apiece on the BSE.
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