The Food and Drug Administration in the US has given its tentative approval to Lupin Limited for its Metformin Hydrochloride extended-release tablets, 500 mg and 1000 mg strengths.
The drug is an equivalent to Andrx Labs LLC's Fortamet® 500 mg and 1000 mg tablets that are administered to improve glycemic control in adults with type 2 diabetes mellitus. It needs to be in conjunction with diet and exercise.
AdvertisementAfter receiving the final approval from the FDA, Lupin expects its product to have 180 days of marketing exclusivity as it has been the first applicant.
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