FDA Approves Hypertension Generics

8 February 2010 (Last Updated February 8th, 2010 18:30)

The US Food and Drug Administration (FDA) has granted approval for two hypertension generics, Lupin's generic amlodipine/benazepril capsules and labetalol hydrochloride (HCl) injection produced by Sagent. Lupin's amlodipine/benazepril capsules are the AB-rated generic equivalent of Novart

The US Food and Drug Administration (FDA) has granted approval for two hypertension generics, Lupin’s generic amlodipine/benazepril capsules and labetalol hydrochloride (HCl) injection produced by Sagent.

Lupin’s amlodipine/benazepril capsules are the AB-rated generic equivalent of Novartis’ Lotrel capsules and will be available in 2.5mg/10mg, 5mg/10mg, 5mg/20mg and 10mg/20mg capsules. Commercial shipments have already begun.

Lupin Pharmaceuticals president and CEO Vinita Gupta said that this is a significant approval and it broadens the company’s growing portfolio of cardiovascular medications.

Sagent Pharmaceuticals’ labetalol HCl injection will be available in two vial sizes – 100mg per 20mL and 200mg per 40mL, multi-dose vials.

The labetalol HCl injection is the generic equivalent of Prometheus Laboratories’ Trandate (labetalol HCl) injection. Labetalol HCl injection is an adrenergic receptor-blocking agent that has selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions used to control blood pressure in severe hypertension.