Par Pharmaceutical Companies, Inc has begun shipping all four strengths of amlodipine and valsartan tablets, the generic version of Novartis’ Exforge.
Par received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application for amlodipine and valsartan and was granted 180 days of marketing exclusivity. Amlodipine and valsartan is indicated for the treatment of hypertension, to lower blood pressure in patients not adequately controlled on monotherapy and as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
Amlodipine and valsartan tablets contain amlodipine besylate equivalent to 5 mg or 10 mg of amlodipine free-base with valsartan 160 mg or 320 mg providing for the following available combinations: 5 mg/160 mg, 10 mg/160 mg, 5 mg/320 mg, and 10 mg/320 mg strengths. According to IMS Health data, annual US sales of Exforge are approximately $422 million.
Amlodipine and valsartan tablets are contraindicated in patients with known hypersensitivity to any component and should not be coadministered with Aliskiren in patients with diabetes. A black box warning is associated with this product regarding fetal toxicity. Refer to full prescribing information for complete boxed warning.
Par Pharmaceutical Companies, Inc. is a privately held, US-based specialty pharmaceutical company that develops, manufactures and markets high barrier-to-entry generic drugs and niche, innovative proprietary pharmaceuticals through its wholly-owned subsidiary’s.