The FDA has approved Invokana (canagliflozin) tablets, a first-in-class drug indicated as an adjunct to diet and exercise for glycemic control in adults with type 2 diabetes mellitus. Invokana is a sodium-glucose co-trans- porter 2 (SGLT2) inhibitor. The recommended starting dose is 100 mg taken orally once daily prior to the first meal of the day. Invokana is not indicated for the treatment of type 1 diabetes or diabetic ketoacidosis.
Tablets: 100 and 300 mg
For More Information: www.invokanahcp.com
Otsuka Pharmaceutical Co, Ltd and H. Lundbeck A/S
The FDA has approved Abilify Maintena (aripiprazole), an atypical antipsychotic indicated for the treatment of schizophrenia. Abilify Maintena is available as a lyophilized powder for reconstitution as an extended-release injectable suspension. It is to be administered by intramuscular injection to the gluteal muscle by a health care professional. The recommended starting and maintenance dose is 400 mg administered monthly as a single injection.
Lyophilized powder for reconstitution in a vial: 300 mg and 400 mg
For More Information: www.abilifymaintena.com/hcp
Ilaris (canakinumab), an interleukin 1-ß blocker, has received FDA approval for a new indication, the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients 2 years and older. The recommended dosage for treatment of SJIA is 4 mg/kg (with a maximum of 300 mg) for patients with a body weight greater than or equal to 7.5 kg, administered subcutaneously every 4 weeks.
Lyophilized powder for reconstitution in a single-use vial: 180 mg
For More Information: www.ilaris.com
Janssen Biotech, Inc
The FDA has approved Simponi (golimumab) for a new indication as a treatment for adults with moderate to severe ulcerative colitis who have had inadequate response or have been intolerant to prior treatment or who require continuous steroid therapy. The recommended dose is 200 mg administered by subcutaneous injection at week 0, followed by 100 mg at week 2, and then 100 mg every 4 weeks.
Single-dose prefilled SmartJect autoinjector: 50 mg/0.5 mL, 100 mg/1 mL; single-dose prefilled syringe: 50 mg/0.5 mL, 100 mg/1 mL
For More Information: www.simponi.com