Sun Pharmaceutical Industries said it has received approval from US health regulator to market generic Clarinex tablets and Tiazac capsules, used in treating nasal allergies and hypertension, respectively, in the American market.
The Mumbai-based firm has received approval from US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) to market a generic version of Schering Plough's Clarinex tablets, Sun Pharma said in a statement. The company has received the approval for generic Clarinex tablets in the strength of 5 mg.
The tablets are indicated for allergic rhinitis or allergic inflammation of the nasal airways, it said. Allergic Rhinitis occurs when an allergen such as pollen or dust is inhaled by an individual with a sensitised immune system and triggers antibody production.
Clarinex tablets (5 mg) have annual sales of nearly $212 million in the US, it said. In a separate statement, the company said it has received approval from USFDA for generic Tiazac capsules used for treating high blood pressure.
The generic capsules contain Diltiazem Hydrochloride extended release in strength of 120 mg, 180 mg, 240 mg, 300 mg and 360 mg and are therapeutically equivalent to Biovail Corporation's Tiazac capsules, it said.
The capsules are indicated for the treatment of heart diseases including hypertension and also chronic stable angina. Diltiazem Hydrochloride capsules have annual sales of nearly USD 46 million in the US. Shares of Sun Pharma were trading at Rs 2,292 on Bombay Stock Exchange in the late afternoon trade, down 0.56 per cent from its previous close.
