Chewable Metformin One Step Closer to FDA Approval

The FDA has authorized an abbreviated new drug application, which means no further clinical trials are needed to demonstrate the safety or effectiveness of the product. Boston Therapeutics plans to market the new formulation of the generic drug metformin hydrochloride under the brand name Pazametm. The next step before moving on to final approval will be bio-equivalency studies in which the company will have to prove its product is at least as good as generic metformin. US Pharmacies filled 50 million prescriptions for the drug in one form or another in 2010. Boston Therapeutics News Release, Oct 2012