Marksans Pharma gets FDA final approval for Famotidine Tablets

Marksans Pharma said that it has been granted final approval for the over-the-counter (OTC) use of Famotidine Tablets USP, 10 mg and 20 mg from the US Food and Drugs Administration (FDA).

Famotidine Tablets is bioequivalent to Pepcid AC tablets, said the India-based pharma company.

The reference listed drug (RLD) is owned by Johnson & Johnson Consumer and is said to have sales of more than $200 million in the American market.

According to Marksans Pharma, its OTC Famotidine Tablets USP, 10 mg and 20 mg, are acid reducers intended for the treatment of conditions where reduction of stomach acid is required. The indicated conditions are acid indigestion, occasional heartburn, or sour stomach resulting from eating or drinking some foods or beverages.

Mark Saldanha — Marksans Pharma Managing Director said: “We are delighted to continue OTC gastro portfolio expansion for our customers and it will help us to fulfill an important therapy gap created in Antacids market due to Ranitidine withdrawal.”