4 New FDA Approvals to Know from June 2017

Learn about the new products and expanded indications approved by the FDA in June 2017.

1. Baxdela

The FDA approved Melinta Therapeutics’ delafloxacin (Baxdela) on June 19, 2017.¹

Baxdela is indicated to treat adults with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible bacteria. The drug, a fluoroquinolone that exhibits activity against both gram-positive and gram-negative pathogens, will be available as both a 450-mg tablet and a bioequivalent 300-mg IV dose.

Like other fluoroquinolones, Baxdela carries a risk of adverse events such as tendinitis, peripheral neuropathy, and central nervous system effects. Other side effects associated with the drug’s use include nausea, vomiting, diarrhea, and headache.

2. Cotempla XR-ODT

The FDA approved Neos Therapeutics’ methylphenidate extended-release orally disintegrating tablets (Cotempla XR-ODT) on June 19, 2017.²

Cotempla XR-ODT is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in patients aged 6-17 years. It is the first orally disintegrating extended-release methylphenidate product to receive the FDA’s nod.

Adverse events associated with the drug’s use include decreased appetite, difficulty sleeping, nausea, vomiting, indigestion, stomach pain, weight loss, anxiety, dizziness, irritability, mood swings, increased heart rate, and increased blood pressure.

Neos plans to launch Cotempla XR-ODT in child-resistant blister packs during the fall of 2017.

3. Mydayis

The FDA approved Shire’s mixed salts of a single-entity amphetamine product (Mydayis) on June 20, 2017.³

Mydayis, a product consisting of 3 different types of drug-releasing beads, is indicated for the once-daily treatment of ADHD in patients aged 13 years and older.

Adverse events reported by trial participants treated with the drug include difficulty sleeping, decreased appetite, dry mouth, increased heart rate, anxiety, nausea, irritability, and weight loss.

Shire plans to launch the Mydayis during the third quarter of 2017.

4. Rituxan Hycela

The FDA approved Genentech’s rituximab and hyaluronidase human (Rituxan Hycela) on June 22, 2017.⁴

Rituxan Hycela is indicated for the treatment of follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), and chronic lymphocytic leukemia (CLL) in adults. The drug, a subcutaneous injection, includes the same monoclonal antibody as intravenous rituximab (Rituxan) in combination with hyaluronidase human, an enzyme that helps to deliver rituximab under the skin.

Adverse events associated with the use of Rituxan Hycela in patients with FL include infection, low white blood cell count, nausea, constipation, cough, and fatigue. Side effects reported by trial participants with DLBCL include infection, low white blood cell count, hair loss, nausea, and low red blood cell count. Adverse events observed in patients with CLL include infection, low white blood cell count, nausea, low platelet count, fever, vomiting, and injection site redness.

References

• Melinta Therapeutics announces US FDA Approval of Baxdela for acute bacterial skin and skin structure infections [news release]. Melinta’s website. http://melinta.com/melinta-therapeutics-announces-u-s-fda-approval-baxdela-delafloxacin-acute-bacterial-skin-skin-structure-infections-absssi. Accessed June 19, 2017.
• Neos Therapeutics announces FDA approval of Cotempla XR-ODT (methylphenidate) extended-release orally disintegrating tablets for the treatment of ADHD in patients 6 to 17 years old [news release]. Neos’ website. http://investors.neostx.com/phoenix.zhtml?c=254075&p=RssLanding&cat=news&id=2281776. Accessed June 20, 2017.
• U.S. FDA Approves Mydayis (mixed salts of a single-entity amphetamine product) — A New Once-Daily Option for ADHD Symptom Control in Patients 13 Years and Older [news release]. Shire’s website. https://www.shire.com/newsroom/2017/june/w6x937. Accessed June 21, 2017.
• FDA Approves Rituxan Hycela (Rituximab and Hyaluronidase Human) for Subcutaneous Injection in Certain Blood Cancers [news release]. Genentech’s website. https://www.gene.com/media/press-releases/14670/2017-06-22/fda-approves-rituxan-hycela-rituximab-an. Accessed June 22, 2017.