6 New Drug Approvals Pharmacy Techs Should Know

Learn about the new drugs and expanded indications approved by the FDA in June 2016.

1. Byvalson

The FDA approved Allergan’s nebivolol and valsartan (Byvalson) on June 7, 2016. It’s the first and only fixed-dose combination of a beta blocker and angiotensin receptor blocker to receive FDA approval, and it’s indicated for the treatment of hypertension.

The drug is contraindicated in pregnant women, as its use could potentially cause injury or death to the fetus.

Allergan plans to launch Bylvason as a 5 mg/80 mg tablet in the second half of 2016.

2. Epclusa

The FDA granted approval to Gilead Sciences’ sofosbuvir and velpatasvir (Epclusa) on June 28, 2016. The drug is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) both with and without cirrhosis, and it can also be used in combination with ribavirin in patients with moderate to severe cirrhosis.

Epclusa is notable for being the first and only HCV treatment approved to treat all 6 major genotypes of the disease.

Adverse events associated with the use of Epclusa include headache and fatigue. Additionally, the drug shouldn’t be used alongside amiodarone, as serious slowing of the heart rate and cases requiring pacemaker intervention have been reported when amiodarone is used with sofosbuvir in combination with another HCV direct-acting antiviral.

3. GoNitro

The FDA approved Espero Pharmaceuticals’ nitroglycerin sublingual powder (GoNitro) on June 14, 2016.

GoNitro is indicated for the acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. The drug is currently the only FDA-approved short-acting nitrate in a stabilized crystal granule form.

The most common side effects reported by trial participants treated with GoNitro include headache, dizziness, and paresthesia. Nausea, vomiting, and weakness have also been observed in some patients. Additionally, the drug isn’t recommended for patients who are taking sildenafil, avanafil, or other PDE-5 inhibitors.

Espero plans to launch GoNitro in single-dose, 400-mcg packages during the second half of 2016.

4. Rayaldee

The FDA granted approval to OPKO Health’s calcifediol (Rayaldee) extended-release tablets on June 21, 2016.

Rayaldee is indicated for the treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease who are vitamin D deficient. However, it isn’t intended for use in patients with stage 5 chronic kidney disease.

Adverse events associated with the use of Rayaldee include hypercalcemia, anemia, nasopharyngitis, and increased blood creatinine.

5. Vaxchora

The FDA approved PaxVax’s Vaxchora on June 11, 2016. The single-dose oral, live attenuated cholera vaccine is indicated for the prevention of cholera caused by serogroup 01 in adults aged 18 to 64 years who are traveling to cholera-affected areas. It’s currently the only immunization to receive FDA approval for cholera prevention.

The vaccine comes in a single oral liquid dose of around 3 fluid ounces and should be taken at least 10 days prior to travel. Adverse events associated with the administration of Vaxchora include tiredness, headache, abdominal pain, nausea, vomiting, lack of appetite, and diarrhea.

6. Zinbryta

In early June, the FDA approved Biogen and AbbVie’s daclizumab (Zinbryta) for the treatment for adults with relapsing forms of multiple sclerosis (MS).

Zinbryta is a long-acting injection that is self-administered by the patient every month. It should generally be used only in patients who don’t respond well to 2 or more MS drugs.

Adverse effects reported by trial participants treated with Zinbryta include cold symptoms, upper respiratory tract infection, rash, influenza, and dermatitis, depression, rash, and increased alanine aminotransferase.

Zinbryta was approved with a boxed warning alerting patients and providers to an associated risk of severe liver injury, as well as conditions like noninfectious colitis, skin reactions, and enlargement of the lymph nodes. The drug is available only through the Risk Evaluation and Mitigation Strategy program.