FDA: FDA approvals March 7

March 6, 2014

FDA drug approvals for the week ending March 7

Testosterone undecanoate (Aveed, Endo International) injection was approved for the treatment of adult men with hypogonadism (commonly known as Low-T) that is associated with a deficiency or absence of the male hormone testosterone

Exenatide extended-release for injectable suspension (Bydureon Pen, AstraZeneca) 2 mg was approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

Hyaluronate acid injection (Monovisc, Anika Therapeutics) was approved for the treatment of pain and improve joint mobility in patients with osteoarthritis of the knee. It is the first FDA-approved single-injection product with HA from a non-animal source.

Metreleptin for injection (Myalept, Amylin Pharmaceuticals) was approved as replacement therapy to treat the complications of leptin deficiency, in addition to diet, in patients with congenital generalized or acquired generalized lipodystrophy.

Ivacaftor (Kalydeco, Vertex Pharmaceuticals) was approved for patients with cystic fibrosis aged 6 years and older who have 1 of 8 additional mutations in the cystic fibrosis transmembrane conductance regulator gene.

Droxidopa (Northera, Chelsea Therapeutics) was approved for the treatment of neurogenic orthostatic hypotension.

Elosulfase alfa (Vimizim, BioMarin Pharmaceuticals) was approved for the treatment of Mucopolysaccharidosis Type IV A (Morquio A syndrome).

Ibrutinib (Imbruvica, Pharmacyclics) was approved for the treatment of patients with chronic lymphocyctic leukemia who have received at least 1 previous therapy.