Jubilant Life Science’s arm receives USFDA approvals for 4 Dosage Formulations

20 Sep 2012 Evaluate

Jubilant Life Sciences’ US subsidiary - Jubilant Cadista Pharmaceuticals Inc. has received approvals from the U.S. Food and Drug Administration (US FDA) for Escitalopram Tablets USP, 5mg, 10mg and 20mg, Olanzapine Orally Disintegrating Tablet 5mg, 10mg, 15 mg and 20mg, Losartan Potassium Tablets USP, 25 mg, 50mg and 100 mg and Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg, 100 mg/12.5 mg and 100 mg/25 mg.

Escitalopram is used for acute treatment of generalized anxiety disorder and acute and maintenance treatment of major depressive disorders with its branded version LEXAPRO enjoying a market size of about $ 2.7 Billion.

Olanzapine ODT is a bioequivalent generic version of ZYPREXA ZYDIS Orally Disintegrating Tablets indicated for the treatment of schizophrenia and for the short term treatment of acute manic or mixed episodes associated with Bipolar I disorder.

Losartan Potassium is a potent, highly specific angiotensin receptor blocker (ARB).It is desirable for an effective treatment of hypertension and also lowers the chance of stroke in patients with high blood pressure and heart problem called left ventricular hypertrophy.

Losartan Potassium and Hydrochlorothiazide Tablets is a combination of ARB and a diuretic.  Annual sales for the branded drug HYZAAR is approximately $ 670 Million. Jubilant has already launched generic versions of both in Europe and the two filings are awaiting approval in few other markets.

Escitalopram and Olanzapine ODT would be manufactured in Jubilant’s dosage formulations facility at Roorkee, India. Losartan Potassium and its variant would be manufactured at the facility in Maryland,USA.

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