Teva Launches Generic Version of Ranexa Extended-Release Tablets in the United States
30 May 2019 - - Israeli generic drug specialist Teva Pharmaceutical Industries Ltd., (NYSE: TEVA) (TASE: TEVA) has launched a generic version of Ranexa1 (ranolazine) Extended-Release Tablets, 500 mg and 1000 mg, in the US, the company said.

Ranolazine Extended-Release Tablets are indicated for the treatment of chronic angina.

With nearly 500 generic medicines available, Teva has the largest portfolio of FDA-approved generic products on the market and holds the leading position in first-to-file opportunities, with over 100 pending first-to-files in the US.

Currently, one in eight generic prescriptions dispensed in the US is filled with a Teva generic product.

Ranolazine Extended-Release Tablets has annual sales of nearly USD 938m in the US, according to IQVIA data as of February 2019.

Ranolazine Extended-Release Tablets are indicated for the treatment of chronic angina. Ranolazine Extended-Release Tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.

Ranolazine Extended-Release Tablets are contraindicated in patients taking strong inhibitors of CYP3A; patients taking inducers of CYP3A; and patients with liver cirrhosis.

Ranolazine blocks IKr and prolongs the QTc interval in a dose-related manner. Clinical experience in an acute coronary syndrome population did not show an increased risk of proarrhythmia or sudden death.

However, there is little experience with high doses (greater than 1,000 mg twice daily) or exposure, other QT-prolonging drugs, potassium channel variants resulting in a long QT interval, in patients with a family history of (or congenital) long QT syndrome, or in patients with known acquired QT interval prolongation.

Acute renal failure has been observed in some patients with severe renal impairment (creatinine clearance less than 30 mL/min) while taking Ranolazine Extended-Release Tablets.

In controlled clinical trials of angina patients, the most frequently reported treatment-emergent adverse reactions (greater than 4% and more common on Ranolazine Extended-Release Tablets than on placebo) were dizziness, headache, constipation, and nausea. Dizziness may be dose-related.