Availability: Juvisync is available in tablets of 100 mg sitagliptin/10 mg simvastatin, 100 mg sitagliptin/20 mg simvastatin, and 100 mg sitagliptin/40 mg simvastatin.
Drug labeling changes
Product: Tapentadol extended release (Nucynta ER)
(800) JANSSEN (526-7736)
Reason for label change: Nucynta ER (a drug in the class known as opiate analgesics) was approved in 2011 to treat moderate to severe chronic pain that necessitates constant pain management. The FDA has approved it this year specifically to treat pain from diabetic peripheral neuropathy (nerve damage in the feet, legs, and hands). Nucynta ER is taken twice daily and is available in 50-, 100-, 150-, 200-, and 250-mg tablets.
Product: Exenatide (Byetta)
Reason for label change: The FDA has approved the use of Byetta in combination with insulin glargine (Lantus, a long-acting insulin).
Product: Insulin detemir (rDNA origin) injection (Levemir)
Manufacturer: Novo Nordisk
Reason for label change: The FDA has approved Levemir for use by pregnant women with diabetes after the results of a clinical trial indicated that the drug did not increase the risk of harm to the fetus.
Product: Ranibizumab injection (Lucentis)
Manufacturer: Genentech USA, Inc.
(866) LUCENTIS (582-3684)
Reason for label change: The FDA has approved Lucentis for use in treating diabetic macular edema (swelling of the central part of the retina in the eye). Lucentis had already been approved for the treatment of age-related macular degeneration.
Product: Linagliptin (Tradjenta)
Manufacturer: Boehringer Ingelheim
Reason for label change: The FDA has approved Tradjenta for use in combination with insulin by people with Type 2 diabetes, and for use by people with Type 2 diabetes who also have severe, chronic kidney problems.