Marksans Pharma arm receives USFDA nod for acid reflux treatment drug

Marksans Pharma Ltd on Friday, August 8, said it has secured the final approval from the United States Food and Drug Administration (USFDA) for Omeprazole delayed-release tablets used for treating heartburn.The US health regulator has awarded a final approval to the pharmaceutical company’s wholly-owned subsidiary, Marksans Pharma Inc.’s Abbreviated New Drug Application (ANDA) for Omeprazole Delayed-Release Tablets in the dosage of 20mg (OTC).

The approved product is a bioequivalent to the reference listed drug (RLD), Prilosec Delayed-Release tablets of the same dosage, of the leading biopharmaceutical major AstraZeneca Pharmaceuticals LP, the company informed the stock exchanges in a filing.

The Omeprazole tablets are recommended in the treatment of heartburn, along with certain other conditions that are caused by too much acidity in the stomach, Marksans Pharma said. Omeprazole tablets are also used in the treatment of gastric and duodenal ulcers, erosive esophagitis and gastroesophageal reflux disease (GERD).Shares of Marksans Pharma Ltd rallied as much as 1.11% to hit an intraday high of ₹217.15 per piece on the BSE. However, the pharma stock pared some of its early gains to trade 0.28% lower at ₹214.15 apiece on the BSE at 11:42 AM.

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