Shilpa Medicare secures final US FDA nod for psoriatic arthritis drug
Shilpa Medicare revealed that Apremilast Tablets, 10 mg, 20 mg, and 30 mg is a generic equivalent of reference listed drug (RLD) OTEZLA of Celgene.
Shares of Shilpa Medicare gained over 10 percent on Tuesday, after the pharmaceutical company said on Monday that it received the United States Food and Drug Administration's (USFDA) final approval for its Abbreviated New Drug Application (ANDA), Apremilast Tablets, 10 mg, 20 mg, and 30 mg. Apremilast Tablets are used for the treatment of adult patients with active psoriatic arthritis.
The product is executed from a contract manufacturing site, the company said in a statement.
Shilpa Medicare revealed that Apremilast Tablets, 10 mg, 20 mg, and 30 mg is a generic equivalent of reference listed drug (RLD) OTEZLA of Celgene.
The US market for Apremilast Tablets, 10 mg, 20 mg, and 30 mg is approximately $3.55 billion, according to IQVIA MAT Q4 2022 data.
Last month, the Bengaluru-headquartered company received 2 observations by US FDA for its Unit 7 at Hyderabad. In February, the company’s Bengaluru facility Unit 6 registered with Ministry of Health, United Arab Emirates, which enabled the company to register products in UAE for commercialisation.
Shilpa Medicare revealed its Q3 earnings in February. The company reported a net loss of Rs 6.6 crore against a profit of Rs 9.6 crore in the same quarter last year. The company’s Earnings before interest, taxes, depreciation and amortization (EBITDA) also plummeted over 30 percent to Rs 31.3 crore against Rs 45.1 crore in the same quarter last year.
The shares of Shilpa Medicare were trading 10.5 percent higher on the BSE at Rs 257.7 apiece around 11am.
First Published: Apr 10, 2023 7:04 PM IST
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