Marksans Pharma bags USFDA nod for Acetaminophen, Ibuprofen Tablets

Mumbai: Marksans Pharma Ltd., a provider of consumer self-care products, has announced that it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application ("ANDA") for Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg, over the counter ("OTC") bioequivalent of Advil Dual Action Tablets 250 mg/125 mg.

The Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC) are bioequivalent to the reference listed drug (RLD), Advil Dual Action of GlaxoSmithKline Consumer Healthcare Holdings (US) LLC.

Advil Dual Action was first available as an over-the-counter drug in 2020.

The pivotal approval, Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg provides relief for multiple pain-related symptoms by combining two powerful ingredients indicated for OTC pain relief, ibuprofen and acetaminophen. Ibuprofen works through the body targeting pain at the source while Acetaminophen blocks pain signal to the brain. The innovation takes these two powerful pain fighting ingredients and combines them into one tablet to offer fast, strong pain relief. The company plans to launch the product immediately.

Commenting on the approval, Mark Saldanha, Managing Director of the Company said, "We are committed to expanding our portfolio in OTC Pain Management, this approval further demonstrates our regulatory and manufacturing capabilities and our strength to follow a focused growth approach. We will continue to work diligently towards sustaining this momentum in the coming quarters."

Read also: USFDA nod to Marksans Pharma Famotidine Tablets for OTC use

Read also: Marksans Pharma concludes acquisition of Tevapharm India's Goa manufacturing site