Marksans Pharma Ltd on Friday said it has received final approval from the US health regulator for its generic version of Famotidine tablets indicated for the treatment of acid indigestion and heartburn.
The approval granted by the US Food & Drugs Administration (USFDA) for the abbreviated new drug application (ANDA) of Famotidine tablets is for strengths of 10 mg and 20 mg for over-the-counter (OTC) use, Marksans Pharma said 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 which has sales of over USD 200 million in the US market, it added.
”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 the Antacids market due to Ranitidine withdrawal,” Marksans Pharma Managing Director Mark Saldanha said.
The company’s OTC Famotidine tablets are acid reducers, 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, it added.
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