Monica Holmberg, PharmD, BCPS

The FDA has expanded the indication of Merck's Isentress (raltegravir) to include pediatric patients.

The FDA has approved Vertex Pharmaceuticals, Inc's Kalydeco (ivacaftor) tablets for the treatment of cystic fibrosis in patients who are 6 years and older.

Amylin Pharmaceuticals, Inc's Bydureon (exentatide extended-release for injectable suspension) is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

Bristol-Myers Squibb's Sprycel (dasatinib) tablets were approved by the FDA for the treatment of adults with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase.

The FDA approved Eylea (aflibercept) injection for the treatment of neovascular age-related macular degeneration.

The FDA approved Lundbeck, Inc's Onfi (clobazam) as an adjunctive treatment for seizures associated with Lennox-Gastaut syndrome in patients that are 2 years and older.

Gilead Sciences, Inc's Complera received approval from the FDA for use as a complete regimen for the treatment of HIV-1 infection in treatment-naïve adults.

The FDA approved a new formulation of immediate-release oxycodone. Oxecta (oxycodone HCI), for the treatment of acute and chronic moderate to severe pain.

The FDA approved a subcutaneous formulation of Bristol-Myers Squibb's Orencia (abatacept) for the treatment of moderately to severely active rheumatoid arthritis in adults.

The FDA approved Genentech's Zelboraf (vermurafenib) for the treatment of unresectable or metastatic melanoma with BRAF V600E mutation.

The FDA approved Lazanda (fentanyl) nasal spray for the management of breakthrough pain in opioid-tolerant cancer patients 18 years or older.

The FDA appoved Gralise (gabapentin) for the management of postherpetic neuralgia in adult patients.

The FDA has granted accelerated approval to Seattle Genetics, Inc's Adcetris (brentuximab vedotin). Adcetris is indicated for the treatment of Hodgkin lymphoma (HL) after failure of autologous stem cell transplant (ASCT) or after failure of at least 2 prior multiagent chemotherapy regimens in patients who are not candidates for ASCT.

The FDA has granted acceleration approval for Adcetris (brentuximba vedotin) for the treatment of Hodgkin lymphoma.

The FDA approved Tradjenta (linagliptin) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

The FDA approved Duexis (ibuprofen and famotidine) tablets for the relief of the symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcer.

The recent approval pf Yervoy (ipilimumab) for intravenous infusion offers the first treatment approved for patients with late-stage skin cancer.

The FDA approved Krystexxa (pegloticase) Injection for the treatment of chronic gout in adult patients who are refractory to conventional therapy.

Eurand Pharmaceuticals' Zenpep (pancrelipase) Delayed-Release Capsules have been approved by the FDA for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.

The FDA recently approved Centocor Ortho Biotech's Stelara (ustekinumab)for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Astepro Nasal Spray 0.15% is the first nasal antihistamine to be available with once-daily dosing.