4 New FDA Approvals Pharmacy Techs Should Know


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

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

1. Amrix

The FDA recently approved a new administration method for Teva’s extended-release cyclobenzaprine hydrochloride (Amrix). The skeletal muscle relaxant indicated for the relief of muscle spasm associated with painful musculoskeletal conditions can now be sprinkled onto a tablespoon of applesauce and swallowed immediately without chewing.

The agency noted that this new administration method should only be used by patients able to reliably swallow applesauce without chewing. Additionally, other foods should not be substituted for applesauce, as they have not been tested for use.

The most common adverse events associated with the use of Amrix include dry mouth, dizziness, fatigue, nausea, dyspepsia, and constipation. The drug’s use is contraindicated in patients taking monoamine oxidase inhibitors, as well as those with arrhythmias, heart block or conduction disturbances, or congestive heart failure. It also should not be taken during the acute recovery phase of myocardial infarction.

2. CyPass Micro-Stent

On August 3, 2016, the FDA approved Alcon’s CyPass Micro-Stent, a micro-invasive surgical device indicated for patients with mild to moderate primary open-angle glaucoma in conjunction with cataract surgery.

The most common side effects associated with the device’s use include best-corrected visual acuity loss, anterior chamber cell and flare, worsening of visual field mean deviation by 2.5 or more decibels, intraocular pressure (IOP) increase, and corneal edema.

Following the FDA’s decision, Alcon CEO Mike Ball stated that CyPass Micro-Stent “will provide a less-invasive means of lowering IOP than traditional glaucoma surgery.” He also expressed hope that device would lower patients’ dependence on topical glaucoma medication.

3. Oseltamivir Phosphate

In preparation for the 2016-2017 flu season, the FDA approved Natco Pharma’s oseltamivir phosphate on August 4, 2016. This generic version of Roche’s Tamiflu is indicated for the treatment of influenza types A and B in patients 2 weeks and older who have had flu symptoms for no more than 48 hours. It can also be used to prevent flu in patients 1 year and older.

The FDA emphasized that Tamiflu and its generic are not replacements for an annual flu shot. The agency also noted that the drug does not treat or prevent illness caused by infections other than the influenza, or prevent bacterial infections that may occur with the flu.

Further research is needed to establish oseltamivir phosphate’s effectiveness in patients who start treatment after 2 days of developing symptoms or in those with weakened immune systems.

Natco Pharma’s generic version of Tamiflu will be available in 30 mg, 45 mg, and 75 mg oral capsules.

4. Qbrelis

The FDA recently approved Silvergate Pharmaceuticals’ lisinopril oral solution (Qbrelis) for the treatment of hypertension in adults and children 6 years and older. The angiotensin-converting enzyme inhibitor is also indicated for the reduction of signs and symptoms of systolic heart failure, as well as the for the reduction of mortality in hemodynamically stable patients within 24 hours of acute myocardial infarction.

The first lisinopril oral solution to receive the agency’s nod, Qbrelis allows for the use of weight-based dosing in children 6 years and older. The drug is also a boon to patients who have difficulty swallowing tablets.

Adverse events associated with the use of Qbrelis include headache, dizziness, and cough in hypotension patients, chest pain in trial participants with systolic heart failure, and renal dysfunction in those with acute myocardial infarction. The drug was approved with a boxed warning alerting patients and providers to a risk of fetal toxicity.

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