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Zydus gets FDA approval for skin, heart and acid reflux generics Posted 15/02/2019

Zydus Cadila has received final approval from the US Food and Drug Administration (FDA) to market betamethasone dipropionate cream, 0.05%, a generic version of Diprolene® AF, and generic amlodipine and atorvastatin tablets (Caduet®). It has also received tentative FDA approval to market generic esomeprazole magnesium delayed-release capsules (Nexium®). This brings the total approvals of the Zydus group to 247, and it has so far filed over 330 abbreviated new drug applications (ANDAs) since the filing process commenced in the 2003‒2004 financial year.

Betamethasone dipropionate cream is a strong corticosteroid used to treat corticosteroid-responsive dermatoses by relieving the inflammation and pruritus that often occurs with these conditions.

Amlodipine and atorvastatin tablets have been approved in the strengths of 2.5 mg/10 mg, 2.5 mg/20 mg, 2.5 mg/40 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 5 mg/80 mg, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg. These tablets combine two active ingredients, amlodipine besylate (a calcium channel blocker) and atorvastatin calcium (an HMG CoA-reductase inhibitor). Amlodipine is used to treat hypertension and coronary artery disease. It works by lowering blood pressure to reduce the risk of cardiovascular events, primarily myocardial infarctions and strokes. Atorvastatin is used as an adjunct therapy to diet in the prevention of cardiovascular disease and hyperlipidaemia.

Esomeprazole is a proton pump inhibitor that reduces the amount of acid secreted by the stomach. It is used to reduce the risk of gastric ulcers, and in the treatment of gastroesophageal reflux disease and pathological hypersecretory conditions, including Zollinger-Ellison syndrome. It is also used to eradicate Helicobacter pylori to reduce the risk of duodenal ulcer recurrence.

These recently approved products will all be manufactured at Zydus’ manufacturing facilities in Ahmedabad, India.

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