Marksans Pharma Ltd announced on Friday that it has received final approval from the US Food and Drug Administration for its generic version of Famotidine tablets, which are used to treat acid indigestion and heartburn. The US Food and Drug Administration (USFDA) approved the abbreviated new drug application (ANDA) for Famotidine tablets in strengths of 10 mg and 20 mg for over-the-counter (OTC) use, according to Marksans Pharma in a regulatory filing.
The product is bioequivalent to the reference-listed drug (RLD), Pepcid AC tablets, a registered trademark of Johnson & Johnson Consumer Inc with over USD 200 million in sales in the US market, according to the company.
“We are excited to continue expanding our OTC gastro portfolio for our customers, and it will assist us in filling an important therapy gap created in the Antacids market due to Ranitidine withdrawal,” Marksans Pharma Managing Director Mark Saldanha said. The company’s over-the-counter Famotidine tablets are acid reducers used to treat conditions requiring stomach acid reduction, such as acid indigestion, occasional heartburn, or sour stomach caused by eating or drinking certain foods or beverages, it added.