Mylan Launches Generic Diabetes Drug

Mylan has launched metformin hydrochloride extended-release tablets, the generic version of Watson’s Fortamet, in 500 mg and 1000 mg doses. This generic product is indicated for use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Fortamet is designed to help type 2 diabetes patients manage hyperglycemia. The drug’s dosage regimen varies based on the effectiveness and tolerance of the patient. The maximum recommended daily dose is 2500 mg.

In a double-blind, randomized, active-controlled study with 680 patients, Fortamet was compared with immediate-release metformin, taken twice per day. Doses were adjusted within the first 6 weeks based on fasting plasma glucose levels. Eventually, 76 of the Fortamet participants and 49 of the immediate-release metformin participants withdrew from the study. A total of 18 of the Fortamet individuals withdrew due to a lack of efficacy.

Metformin carries a black box warning that claims a risk of potentially fatal complications linked to lactic acidosis, which may be caused by an accumulation of metformin. The condition is associated with hypothermia, hypotension and resistant bradyarrhythmias.

The most common adverse effects associated with Fortamet are headache, infection, diarrhea, nausea, dyspepsia, flatulence, rhinitis, accidental injury, and abdominal pain.