FDA Actions in Brief February 2013


Recent FDA Approvals (through February 2013) related to (Ado-trastuzumab, Kadcyla, Genentech, Everolimus, Zortress, Novartis, Adapalene, benzoyl peroxide, Epiquo, Galderma, pomalidomide, Pomalyst, Celgene, alogliptin, Nesina, Takeda Pharmaceuticals, Kazano, Oseni, imatinib, Gleevec, mesalamine, Delzicol, Warner Chilcott, mipomersen sodium, Kynamro, Genzyme, Isis Pharmaceuticals, Merck, Oxutrol for Women, glycerol phenylbutyrate, Ravicti, Hyperion Therapeutics, pneumococcal 13-valent Conjugate Vaccine, Prevnar 13, Pfizer


Ado-trastuzumab emtansine (Kadcyla, Genentech, a member of the Roche Group) was approved for patients with HER2-positive, metastatic breast cancer.

Everolimus (Zortress, Novartis) was approved to prevent organ rejection in adult liver transplant patients.

Adapalene 0.1%/benzoyl peroxide 2.5% (Epiduo, Galderma) was approved to treat acne in children aged 9 and older.

Pomalidomide (Pomalyst, Celgene) was approved to treat patients who have received at least 2 prior therapies including lenalidomide and bortezomib and have demonstrated disease progression on or within 60 days of completion of the last therapy.

Alogliptin (Nesina, Takeda Pharmaceuticals), alogliptin and metformin hydrochloride (Kazano, Takeda Pharmaceuticals), and alogliptin and pioglitazone (Oseni, Takeda Pharmaceuticals) were approved for use with diet and exercise to improve blood sugar control in adults with type 2 diabetes.

Imatinib (Gleevec, Novartis) was approved for the treatment of children newly diagnosed with Philadelphia chromosome positive acute lymphoblastic leukemia.

Mesalamine (Delzicol, Warner Chilcott) 400-mg delayed-release capsules were approved for the treatment of ulcerative colitis.

Mipomersen sodium (Kynamro, Genzyme and Isis Pharmaceuticals) once-a-week injection as an addition to lipid-lowering medications and diet was approved to treat patients with homozygous familial hypercholesterolemia.

Over-the-counter Oxytrol for Women (Merck) was appoved for treatment of overactive bladder in women aged 18 years and older.

Glycerol phenylbutyrate (Ravicti, Hyperion Therapeutics) was approved for the chronic management of some urea cycle disorders in patients aged 2 years and older.

Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein] (Prevnar 13, Pfizer) was approved for use in older children and adolescents aged 6 years through 17 years for active immunization for the prevention of invasive disease caused by the 13 Streptococcus pneumoniae serotypes contained in the vaccine. For this age group, Prevnar 13 is administered as a 1-time dose to patients who have never received Prevnar 13.

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