USFDA nod to Marksans Pharma Famotidine Tablets for OTC use
Mumbai: Marksans Pharma Limited has announced that the company 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.
Read also: Marksans Pharma to acquire 100 percent stake in Access Healthcare for Rs 27 crore
"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.
Read also: Marksans Pharma subsidiary gets UK MHRA okay for Fluoxetine 20mg/5ml Oral Solution
Marksans Pharma Limited headquartered at Mumbai, India is engaged in Research, Manufacturing & Marketing of generic pharmaceutical formulation in the global markets. The company's manufacturing facilities located in India, USA and UK are approved by several leading regulatory agencies including USFDA, UKMHRA and Australian TGA. The company's product portfolio spreads over major therapeutic segments of CVS, CNS, Antidiabetic, Pain Management, Gastroenterological and Antiallergies. The company is marketing these products globally.
