Unichem gets USFDA approval for ranolazine ER tablets, 500 mg and 1000 mg

The U.S. Food and Drug Administration (FDA) has granted Unichem Laboratories Ltd. approval for the production and sale of Ranolazine Extended-Release Tablets, 500 mg and 1000 mg.

The agency’s nod of approval paves the way for Unichem to begin marketing the tablets, which are indicated for the treatment of chronic angina, a type of chest pain caused by reduced blood flow to the heart.

Ranolazine, the active ingredient in the tablets, works by increasing the availability of intracellular energy, allowing the heart to get the fuel it needs to reduce the frequency and severity of angina.

In granting its approval, the FDA noted that Unichem’s tablets had been evaluated through a rigorous review process that included a randomized, double-blind, placebo-controlled clinical trial. This trial demonstrated that, compared to a placebo, patients taking the tablets had an average reduction in the frequency of angina attacks of nearly 40%.

Unichem’s tablets also showed greater efficacy in treating angina than an immediate-release version of ranolazine.

The FDA determined that these tablets offer patients with chronic angina an effective, safe, and convenient treatment option.

The agency cautioned, however, that ranolazine can cause increases in the levels of certain liver enzymes, which can indicate liver injury. Patients taking the tablets should have their liver enzymes monitored regularly.

In granting Unichem’s request for approval, the FDA has opened the door for those suffering from chronic angina to access a medication that can provide them with the relief they need.