6 New FDA Approvals Pharmacy Techs Should Know


Learn about the new products and expanded indications approved by the FDA in July 2016.

Learn about the new products and expanded indications approved by the FDA in July 2016.

1. Absorb GT1 Bioresorbable Vascular Scaffold System

The FDA approved Abbott Vascular’s Absorb GT1 Bioresorbable Vascular Scaffold System on July 5, 2016.

The first coronary artery disease stent that is designed to be absorbed by a patient’s body, the Absorb GT1 BVS is inserted in a patient’s artery during angioplasty and releases everolimus to limit the growth of scar tissue. The device is then gradually absorbed over approximately 3 years, leaving behind only 4 small platinum markers to indicate where the tube was inserted.

Adverse events linked to the insertion or use of the Absorb GT1 BVS include allergic reactions to the device materials or medications used in the procedure, infection or irritation at the catheter insertion site, internal bleeding, the development of abnormal connections between arteries and veins, embolism, or other potentially fatal coronary artery complications that may require medical intervention.

2. Adlyxin

The FDA approved Sanofi’s lixisenatide (Adlyxin) on July 27, 2016. It’s a glucagon-like peptide-1 receptor agonist indicated for the improvement of glycemic control, in conjunction with diet and exercise, in adults with type 2 diabetes.

The drug will be available in a disposable prefilled injectable pen in a single dose of 20 μg. Patients will also receive a disposable prefilled pen in a single dose of 10 μg that should be used once daily for the first 14 days.

The most common side effects reported by trial participants treated with Adlyxin include nausea, vomiting, headache, diarrhea, dizziness, and severe hypersensitivity reactions. Patients treated with both Adlyxin and other antidiabetic drugs, such as sulfonylurea and/or basal insulin, may also experience hypoglycemia. In addition, severe hypersensitivity reactions, including anaphylaxis, were reported in clinical trials.

3. Namzaric XR

The FDA has expanded the label of Allergan’s extended-release memantine hydrochloride and donepezil hydrochloride (Namzaric XR). With this new approval, patients with moderate to severe Alzheimer’s disease who are stabilized on 10 mg of donepezil hydrochloride (Aricept) are able to start combination therapy directly with Namzaric XR.

Allergan also announced that Namzaric XR will now be available in 4 dosage strengths, with the manufacturer planning to launch the new strengths in September 2016.

The most common adverse effects associated with the use of Namzaric XR include headache, diarrhea, and dizziness. Patients may also experience nausea and vomiting for up to 3 weeks.

4. Syndros

The FDA approved Insys Therapeutics’ cannabinoid dronabinol oral solution (Syndros) on July 5, 2016.

Syndros is indicated for the treatment of anorexia in patients with AIDS, as well as the treatment of nausea and vomiting in cancer patients undergoing chemotherapy who have no adequately responded to traditional antiemetic treatments.

The most common adverse effects associated with the drug’s use include dizziness, drowsiness, and nausea. Trial participants treated with Syndros have also reported side effects such as abdominal pain, restlessness, itching eyes, cough, and diarrhea.

Insys plans to launch Syndros in the second half of 2016.

5. Synjardy

The FDA expanded the indication of Boehringer Ingelheim’s empagliflozin and metformin hydrochloride (Synjardy) on July 19, 2016.

It was initially approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. With this latest FDA decision, the drug can now be used in treatment-naïve adults.

The most common side events associated with the use of Synjardy include nausea, vomit, and tiredness. The drug’s use is also linked to an increased risk of lactic acidosis, a potentially lethal build-up of lactic acid in the blood.

6. Xiidra

The FDA approved Shire’s lifitegrast ophthalmic 5% solution (Xiidra) on July 13, 2016.

The twice-daily eye drop solution is indicated for the treatment of both the signs and symptoms of dry eye disease in adults. It’s the first prescription product to receive the FDA’s approval for this purpose.

Adverse events reported by trial participants treated with Xiidra include eye irritation, discomfort or blurred vision when the drops are applied to the eyes, and dysgeusia. Patients who wear contact lenses should remove them before instilling the solution and wait at least 15 minutes before placing the lenses back into the eyes.

Shire plans to launch Xiidra in the United States in the third quarter of 2016.

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