Ranbaxy gets USFDA approval for Terazosin

Mumbai: Ranbaxy Pharmaceuticals (RPI), a wholly-owned subsidiary of Ranbaxy Laboratories (RLL), has received the final approval from the US Food and Drug Administration to manufacture and market Terazosin hydrochloride capsules (1, 2, 5 and 10 mgs).

Based on studies, the Ranbaxy formulation has been deemed to be bio-equivalent and therapeutically equivalent to the listed drug Hytrin T capsules by Abbott Laboratories. Terazosin hydrochloride capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). It is also indicated for the treatment of hypertension and can be used alone or in combination with other anti-hypertensive agents such as diuretics or beta-adrenergic blocking agents.

Sales in 2001 for Terazosin capsules, which consisted of the Abbott Lab brand of Hytrin along with five other generic players, aggregated $206.80 million. The approved Ranbaxy formulation is a result of the research and development efforts on the active pharmaceutical ingredient and on the bio-equivalent formulation, both developed at RLL.

It is planned to make the product available for marketing and distribution through the RPI commercial teams within the next 30 to 45 days for all classes of trade, including wholesalers, chain pharmacies and generic distributors that support the dispensing and therapeutic usage of this product.

Says RPI president and CEO Dipak Chattaraj: This product represents yet another addition to the expanding RPI product portfolio that consists not only of solid dosage forms but now includes an increasing number of value-added dosage forms. We see this as another way to distinguish and differentiate RPI from other generic formulators in the US.