Marksans Pharma gets USFDA’s final approval for Famotidine Tablets
10th Mar 2023

Marksans Pharma has received final approval from US Food & Drugs Administration (USFDA) for its Abbreviated New Drug Application (ANDA) of Famotidine Tablets USP, 10 mg and 20 mg for over-the-counter (OTC) use. The product is bioequivalent to the reference listed drug (RLD), Pepcid AC tablets, a registered trademark of Johnson & Johnson Consumer Inc. which has sales of over $200 million in the US market.

Marksans' OTC Famotidine Tablets USP, 10 mg and 20 mg, are acid reducers which used to treat conditions where reduction of stomach acid is needed, such as acid indigestion, occasional heartburn, or sour stomach from eating or drinking certain foods or beverages.

Marksans Pharma together with its subsidiaries operates as an integrated international pharmaceutical company. The company’s business is distribution of pharmaceutical products.