Zydus receives final approval from USFDA to market drug used to relieve chest pain
Mar 09, 2022
By Shalini Bhardwaj
New Delhi [India], March 9 : Zydus Lifesciences Ltd. has received final approval from the United States Food and Drug Administration (USFDA) to market Nitroglycerin Sublingual tablets used to relieve chest pain in people who have certain heart conditions, said the pharmaceutical company on Wednesday.
As per the statement issued by the company, the tablets are in the strengths of 0.3 mg, 0.4mg and 0.6mg (US RLD: Nitrostat Sublingual Tablets).
"Nitroglycerin Sublingual tablets are used to relieve chest pain (angina) in people who have a certain heart condition (coronary artery disease)," said the company.
The company further said that the tablets may also be used before physical activities to help prevent chest pain. Nitroglycerin belongs to a class of drugs known as nitrates.
It stated that the drug will be manufactured at the group's formulation manufacturing facility at SEZ, Ahmedabad.
The group now has 329 approvals and has so far filed over 400 abbreviated new drug applications (ANDAs) since the commencement of the filing process in the financial year 2003-04, added the company statement.