PP_1170x120_10-25-21

FDA gives OK to new Aurobindo generics

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DAYTON, N.J. — Aurobindo Pharma Ltd. has received approval from the Food and Drug Administration for gemfibrozil tablets, omeprazole delayed-release capsules and telmisartan tablets.

The company said Monday that its gemfibrozil tablets (600 mg) are a generic version of Lopid tablets from Pfizer Inc. The medication is indicated as an adjunctive therapy to diet for the treatment of adults with very high elevations of serum triglyceride levels (types IV and V hyperlipidemia) and for reducing the risk of developing coronary heart disease in type IIb patients.

Gemfibrozil tablets totaled U.S. sales of about $35.1 million for the 12 months through the end of July, according to IMS Health data cited by Aurobindo.

Aurobindo announced FDA approval of the omeprazole delayed-release capsules and telmisartan tablets last week.

The omeprazole delayed-release capsules were approved in dosages of 10 mg, 20 mg and 40 mg are bioequivalent to AstraZeneca’s Prilosec delayed-release capsules. The drug is used for the treatment of duodenal and gastric ulcers and gastroesophageal reflux disease (GERD), among other indications. The product has an estimated market size of $422.8 million for the 12 months through July, based on IMS Health figures.

Aurobindo’s telmisartan tablets — approved in strengths of 20 mg, 40 mg and 80 mg — are a generic version of Micardis tablets from Boehringer Ingelheim. Telmisartan is an angiotensin 2 receptor blocker for the treatment of hypertension and cardiovascular risk reduction. Aurobindo said the medication had total sales of $92.2 million for the 12 months ended in July, according to IMS Health data.


ECRM-08-202222

Adheris Health

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Adheris Health