Strides Pharma has said that its step-down wholly owned subsidiary, Strides Pharma Global Pte., Singapore, has received approval for celecoxib capsules, 100 mg, 200 mg, and 400 mg, from the United States Food & Drug Administration (FDA).
The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Celebrex capsules, 100 mg, 200 mg, and 400 mg, of Upjohn US 2 LLC.
The approval of celecoxib capsules strengthens Strides’ portfolio in the anti-inflammatory therapeutic segment. This approval complements the company’s existing products in the same therapy area and enhances its ability to serve a broader patient population with effective, affordable treatment options. Celecoxib is a selective COX-2 inhibitor used for the management of pain and inflammation associated with various conditions including osteoarthritis, rheumatoid arthritis, acute pain, and dysmenorrhea. celecoxib capsules, 100 mg, 200 mg, and 400 mg have a combined market size of ~US$ 116 million as per IMS.
The product will be manufactured at the company’s facility in Puducherry. Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) that works by reducing hormones that cause inflammation and pain in the body. It is commonly prescribed to manage symptoms of arthritis, pain, and other inflammatory conditions.