Mumbai-based Sun Pharmaceutical Industries announced that it received approval from the US Food and Drug Administration to market generic versions of Clarinex tablets and Tiazac capsules. The FDA approval will allow Sun Pharmaceuticals to market the generic drugs in the US.
Clarinex tablets, which are made by Schering Plough, are used to treat allergic rhinitis or allergic inflammation in the nasal airways. Such allergic inflammation typically occurs when allergens-such as pollen or dust-are inhaled by individuals with sensitised immune systems, subsequently triggering antibody production. Sun Pharmaceutical's generic version will have a strength of 5mg. Clarinex tablets rack up annual sales worth almost $212 million in the US alone.
Tiazac capsules, which are made by Biovail Corporation, are used for treating heart diseases such as hypertension and chronic stable angina. The Sun Pharmaceutical generic will have an extended release strength of 120mg,
180mg, 240mg, 300mg and 360mg. Tiazac contains Diltiazem Hydrochloride, which has annual sales valuing almost $46 million in the US market.
The generic medicines will have the same therapeutic effect as the original, brand medicines, the company said.
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