On Wednesday, Zydus Lifesciences, formerly known as Cadila Healthcare, announced that the U.S. Food and Drug Administration (FDA) has approved its Nitroglycerin Sublingual tablets in the U.S. market, according to multiple sources.
The Indian pharma company has received approval from the U.S. drug regulatory body for Nitroglycerine Sublingual tablets in strengths of 0.3 mg, 0.4 mg and 0.6 mg.
Nitroglycerin Sublingual tablets belong to a family of drugs called nitrates. They are often used to prevent angina (chest pain) in people with a heart condition called coronary artery disease (CAD). Chest pain occurs when the heart muscle fails to get enough blood.
Nitrates work by relaxing and dilating blood vessels so blood can flow more easily to the heart. They will not relieve angina once it occurs.
Zydus will manufacture the drug in SEZ, Ahmedabad, India. It now has 329 approvals. The company has filed more than 400 Abbreviated New Drug Approvals (ANDAs) since it commenced the filing process in 2003-04.
Today, Zydus saw a 2.4% rise in share price in early trade after receiving FDA approval yesterday.
Recently, the company has executed an asset purchase agreement with a commercial-stage biopharmaceutical company, BridgeBio Pharma where the former’s US-based biopharmaceutical subsidiary Sentynl Therapeutics will acquire BridgeBio’s Nulibry (fosdenopterin) for Injection.
Nulibry is indicated to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A, a rare condition characterized by brain dysfunction (encephalopathy) that worsens over time. Babies with MoCD appear normal at birth but within a week, they have difficulty feeding and develop seizures that do not improve with treatment.
