USFDA gives approval for OTC Acetaminophen and Ibuprofen Tablets

Acetaminophen and Ibuprofen tablets are a type of medicine that can help relieve minor aches and pains caused by headaches, toothache

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USFDA Approval

Last Updated on July 18, 2023 by The Health Master

New Delhi: Granules India Limited made an announcement stating that the US Food Drug Administration (USFDA) has given its approval to the company’s Abbreviated New Drug Application (ANDA).

The application was filed by Granules Pharmaceuticals, Inc. (GPI), which is a subsidiary of Granules India Limited.

The approved drug is called Acetaminophen and Ibuprofen Tablets, with a strength of 250 mg/125 mg, and it can be purchased over the counter (OTC).

The USFDA has confirmed that this drug is equivalent to Advil® Dual Action with Acetaminophen Tablets, which is manufactured by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC.

Granules India Limited plans to launch this product through its division called Granules Consumer Health (GCH).

Acetaminophen and Ibuprofen tablets are a type of medicine that can help relieve minor aches and pains caused by:

  • Headaches,
  • Toothaches,
  • Backaches,
  • Menstrual cramps,
  • Muscle aches,
  • Minor arthritis pain.

The company has received a total of 59 approvals from the US Food Drug Administration (USFDA) for Abbreviated New Drug Applications (ANDAs). Out of these, 57 approvals are final and two are tentative.

Based on market data from IRI, a company that tracks sales in various outlets, the combined sales of the brand Advil Dual Action with Acetaminophen tablets and store-brand versions in the United States was around $70 million in the past year.

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