FDA Approves Generic Metformin Hydrochloride Extended-Release Tablets

Officials with the FDA have approved Glenmark Pharmaceuticals’ Metformin Hydrochloride Extended-Release Tablets USP, 500 mg and 1000 mg, the generic equivalent of Glumetza® Extended-Release Tablets, 500 mg and 1000 mg (Salix Pharmaceuticals).¹

Metformin hydrochloride extended-release tablets are indicated to for improving glycemic control in patients with type 2 diabetes mellitus, as an adjunct to diet and exercise.²

Glumetza was approved by the FDA in 1995. According to Salix, the recommended starting dose of the drug is 500 mg orally, once daily with the evening meal, and is increased by 500 mg every 1-2 weeks, up to a maximum of 2000 mg.²

In clinical trials, >5% of those studied reported hypoglycemia, diarrhea, and nausea. Salix also includes a boxed warning on its product for metformin-associated lactic acidosis, including fatal cases.²

REFERENCES

• Glenmark Pharmaceuticals receives ANDA approval for Metformin Hydrochloride Extended-Release Tablets USP, 500 mg and 1000 mg [news release]. Mumbai, India; November 26, 2019: Glenmark Pharmaceuticals. [email]. Accessed November 26, 2019.
• Glumetza [prescribing information] Bridgewater, NJ; Salix Pharmaceuticals: August, 2019.