The company’s marketing partner, Alvogen, received ANDA approval from USFDA for Nitroglycerin Sublingual Tablets USP, 0.3 mg, 0.4 mg, and 0.6 mg
Drug firm Natco Pharma announced that its marketing partner, Alvogen, has received final ANDA nod from USFDA for chest pain tablets.
“The company is pleased to announce that its marketing partner Alvogen has received the final approval of Abbreviated New Drug Application (ANDA) from the United States Food and Drug Administration (FDA) for Nitroglycerin Sublingual Tablets USP, 0.3 mg, 0.4 mg, and 0.6 mg,” Natco Pharma said in a BSE filing.
Nitroglycerin sublingual tablets are used to treat episodes of angina (chest pain) in people who have coronary artery disease (narrowing of the blood vessels that supply blood to the heart), it stated.
Pfizer Pharmaceuticals, the company said, markets this drug under its brand Nitrostat Sublingual Tablets in the same strengths mentioned above. As per IQVIA data, Nitroglycerin Sublingual Tablets had total annual sales of around USD 77.3 million in the US market, for the year ending 2018, the company said. Shares of Natco Pharma were trading 0.57 per cent lower at Rs 530.30 apiece on the BSE.