Takeda Pharmaceuticals America, Inc
The FDA has approved Kazano (alogliptin and metformin HCl)—a dipeptidyl-peptidase-4 inhibitor and biguanide combination product—as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (DM). Kazano is not indicated for treatment of type 1 DM or diabetic ketoacidosis. The starting dose should be individualized to the patient, but a maximum recommended daily dose of 25 mg alogliptin and 2000 mg metformin HCl should not be exceeded.
Tablets (mg alogliptin/mg metformin HCl): 12.5/500, 12.5/1000
For More Information: www.takeda.us/products/default.aspx
Marketed by: ViiV Healthcare
The FDA has approved Tivicay (dolutegravir), an HIV-1 integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for treating HIV-1 infection in adults and children 12 years and older and weighing at least 88 lb (40 kg). The recommended dose in treatment-naïve or treatment-experienced INSTI-naïve adults is 50 mg once daily. For pediatric dosing, see the prescribing information. Tivicay may be taken without regard to meals.
Tablets: 50 mg
For More Information: www.viivhealthcare.com/our-medicines/tivicay.aspx
Ceptaris Therapeutics, Inc
The FDA has approved Valchlor (mechlorethamine), an alkylating drug indicated for the topical treatment of stages IA and IB mycosis fungoides–type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy. The recommended dose is once-daily application of a thin film to affected areas of the skin. Valchlor is for topical dermatologic use only.
Gel: 0.016% w/w of mechlorethamine (equivalent to 0.02% mechlorethamine HCl) in 60-g tubes
For More Information: www.valchlor.com
The FDA has approved Mirvaso (brimonidine) topical gel, 0.33%, an alpha-adrenergic agonist for the topical treatment of persistent (nontransient) facial erythema of rosacea in adults 18 years or older. The recommended dose is application of a pea-size amount once daily to each of 5 areas of the face (ie, forehead, chin, nose, and each cheek) while avoiding the eyes and lips. Hands should be washed immediately after application.
Gel, 0.33%: each gram contains 5 mg of brimonidine tartrate
For More Information: www.mirvaso.com