9 New FDA Approvals for Pharmacy Techs to Know


Learn about the new drugs and products approved by the FDA in December 2015.

Learn about the new drugs and products approved by the FDA in December 2015.

1. Basaglar

The FDA approved Eli Lilly and Company’s insulin glargine injection (Basaglar) on December 16, 2015.

This long-acting human insulin analog is indicated for the improvement of glycemic control in adult and pediatric patients with type 1 diabetes, as well as adults with type 2 diabetes.

Basaglar should be administered to patients once a day at the same time each day, with the dose dependent on each patient’s individual needs.

Adverse effects associated with the use of Basaglar include generalized skin reactions, itching at the injection site, rash, weight gain, and edema. Life-threatening allergic reactions have also been observed in patients treated with the drug.

2. Bendeka

On December 8, 2015, the FDA approved Teva Pharmaceuticals and Eagle Pharmaceuticals’ bendamustine hydrochloride injection (Bendeka) for the treatment of chronic lymphocytic leukemia.

The drug is also indicated for patients with indolent B-cell non-Hodgkin lymphoma that has progressed within 6 months of treatment with rituximab.

The most common adverse events associated with the use of Bendeka in patients with non-Hodgkin lymphoma include nausea, vomiting, fatigue, and constipation. Additionally, side effects observed in patients with chronic lymphocytic leukemia who were treated with the drug include nausea, vomiting, fatigue, and pyrexia.

Teva plans to launch Bendeka in the first quarter of 2016.

3. Bridion

The FDA approved Merck’s sugammadex (Bridion) injection on December 15, 2015.

It is approved for the reversal of neuromuscular blockade created by rocuronium bromide and vercuronium bromide, which are used to temporarily paralyze patients undergoing certain types of surgery.

“Bridion provides a new treatment option that may help patients recover sooner from medications used for intubation or ventilation during surgery,” said Sharon Hertz, director of the FDA’s Division of Anesthesia, Analgesia, and Addiction Products, in a press release announcing the agency’s decision. “This drug enables medical personnel to reverse the effects of neuromuscular blocking drugs and restore spontaneous breathing after surgery.”

Adverse events associated with the use of Bridion include anaphylaxis, vomiting, low blood pressure, pain, headache, and nausea.

4. LifeVest

On December 17, 2015, the FDA approved the use of the LifeVest wearable defibrillator for children at risk for sudden cardiac arrest who are ineligible for an implantable defibrillator.

Initially indicated exclusively for patients aged 18 years and older, LifeVest is one of only a few products able to automatically respond to heart abnormalities without the need for a second person.

The wearable defibrillator consists of an electrode belt and garment, and it weighs less than 2 pounds. Children must weigh at least 41 pounds and have a chest size of at least 26 inches in order to wear the device.

In a press release announcing the FDA’s decision, Vasum Peiris, chief medical officer of pediatrics and special populations in the agency’s Center for Devices and Radiological Health, noted that prior to this approval, many health care providers would be forced to use adult devices off-label without instructions for use in pediatric patients.

5. Otiprio

The FDA approved Otonomy’s ciprofloxacin otic suspension (Otiprio) on December 11, 2015.

The drug is indicated for the treatment of bilateral otitis media with effusion in pediatric patients who are undergoing tympanostomy tube placement. Notably, it is the first product to receive the agency’s nod for this purpose.

Otiprio is thermosensitive, maintaining a liquid state at or below room temperature before being intratympanically administered by a physician as a single 0.1-ml dose, causing it to solidify into a gel.

The most common adverse events associated with the use of Otiprio include nasopharyngitis, irritability, and rhinorrhea. The drug is also contraindicated in patients with a history of hypersensitivity to ciprofloxacin, other quinolones, or any of the drug’s components.

Otonomy plans to launch Otiprio in the first quarter of 2016.

6. QuilliChew ER

On December 7, 2015, the FDA approved Pfizer’s chewable formulation of methylphenidate hydrochloride (QuilliChew ER) for the treatment of attention-deficit/hyperactivity disorder (ADHD) in patients aged 6 years and older.

“As a physician, it is important to have treatment choices for patients with ADHD and their caregivers. QuilliChew ER extended-release chewable tablets give healthcare providers an additional treatment option to meet their patients’ needs,” stated Ann C. Childress, MD, the president of the Center for Psychiatry and Behavioral Medicine in Las Vegas, Nevada, in a press release following the announcement of the FDA’s decision.

QuilliChew ER is contraindicated in patients known to be hypersensitive to methylphenidate or other components of the drug, as well as in those who are currently taking monoamine oxidase inhibitors. Because the drug is a Schedule II controlled substance, patients who are prescribed the drug should be monitored for signs of abuse and dependence during therapy.

Pfizer plans to launch QuilliChew ER in 20-mg, 30-mg, and 40-mg dosage strengths during the first quarter of 2016.

7. Uptravi

The FDA approved Actelion’s selexipag (Uptravi) tablets for the treatment of pulmonary arterial hypertension in adults on December 21, 2015.

This oral IP prostacyclin receptor agonist works by relaxing muscles in the walls of blood vessels to dilate them, which decreases elevated pressure in the vessels supplying blood to the lungs.

Adverse effects associated with the use of Uptravi include headache, diarrhea, jaw pain, nausea, myalgia, vomiting, extremity pain, flushing, arthralgia, anemia, decreased appetite, and rash.

The drug was launched in the United States as 200-mcg, 400-mcg, 600-mcg, 800-mcg, 1000-mcg, 1200-mcg, 1400-mcg, and 1600-mcg dosage strengths on January 4, 2015.

8. Vistogard

On December 11, 2015, the FDA approved Wellstat Therapeutics’ uridine triacetate (Vistogard) for the emergency treatment of adults and children who receive an overdose of the chemotherapy drugs fluorouracil or capecitabine.

Vistogard can also been administered to patients who develop life-threatening toxicities within 4 days of receiving these cancer treatments.

The drug, which was previously given orphan designation by the FDA, works by preventing cell damage and cell death caused by fluorouracil.

Vistogard is not recommended for the treatment of non-emergency adverse reactions associated with fluorouracil or capecitabine, as it can diminish the efficacy of these chemotherapy drugs.

The most common adverse events associated with the use of Vistogard include diarrhea, vomiting, and nausea.

9. Zurampic

The FDA approved AstraZeneca’s lesinurad (Zurampic) on December 22, 2015.

Zurampic is indicated for the treatment of high blood uric acid levels associated with gout, when used in combination with a xanthine oxidase inhibitor.

The drug works by inhibiting the function of transporter proteins involved in uric acid reabsorption in the kidney, helping the kidney to excrete uric acid.

Adverse events associated with the use of Zurampic include headache, influenza, increased blood creatinine, and gastroesophageal reflux disease. The drug also carries a boxed warning concerning the risk for renal failure, which may occur when it is used in higher-than-approved doses and without a xanthine oxidase inhibitor.

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