Marksans Pharma Limited hereby announces that it has received final approval from US Food & Drugs Administration 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.
“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”, says Mr. Mark Saldanha, Managing Director of Marksans Pharma Limited.
