5 FDA Drug Approvals to Know from Last Month
Review the new products and expanded indications approved by the FDA in January 2017.
Learn about the new products and expanded indications approved by the FDA in January 2017.
The FDA approved Teva’s fluticasone propionate and salmeterol inhalation powder (AirDuo RespiClick) on January 30, 2017.
AirDuo RespiClick, a corticosteroid and long-acting beta2-adrenergic agonist, is indicated for the twice-daily treatment of asthma in patients aged 12 years and older. The drug is delivered via Teva’s RespiClick breath-activated, multi-dose dry powder inhaler.
The most common adverse effects reported by trial participants treated with AirDuo RespiClick include nasopharyngitis, headache, cough, oral candidiasis, and back pain.
Teva plans to launch the inhaler in 55/14 mcg, 113/14 mcg, and 232/14 mcg strengths later this year.
2. Arymo ER
The FDA approved Egalet Coroporation’s extended-release morphine sulfate tablets (Arymo ER) on January 9, 2017.
Arymo ER is indicated for the management of pain in patients who require long-term opioid treatment and for whom other options may be inadequate.
The drug utilizes Egalet's abuse-deterrent Guardian technology, making it difficult to manipulate via cutting, crushing, grinding, or breaking.
Egalet plans to launch Arymo ER in 15 mg, 30 mg, and 60 mg strengths in the first quarter of 2017.
The FDA expanded the indication of Pharmacyclics and Janssen’s ibrutinib (Imbruvica) on January 19, 2017, allowing the drug to be used to treat marginal zone lymphoma in patients who require systemic therapy or who have received at least 1 anti-CD20-based therapy.
Imbruvica was initially approved in November 2013 for the treatment of mantle cell lymphoma. The drug’s label later grew to include the treatment of chronic lymphocytic leukemia, Waldenström’s macroglobulinemia, and small lymphocytic lymphoma.
Adverse events associated with the use of Imbruvica include thrombocytopenia, fatigue, anemia, diarrhea, bruising, musculoskeletal pain, and nausea.
The FDA approved Allergan’s oxymetazoline cream, 1% (Rhofade) on January 19, 2017.
Rhofade is indicated for the once-daily topical treatment of facial redness associated with rosacea in adults.
Adverse events reported by trial participants treated with Rhofade include application site dermatitis, application site pruritus, application site erythema, application site pain, and worsening inflammatory lesions.
Allergan plans to launch Rhofade in the United States in May 2017.
The FDA expanded the indication of AstraZeneca’s 80/4.5 mcg budesonide and formoterol fumarate dihydrate inhalation aerosol (Symbicort) on January 30, 2017.
Previously approved for the treatment of asthma in patients aged 12 and older, Symbicort 80/4.5 can now be used for this purpose in patients as young as 6 years old. A 160/4.5 version of the inhaler, indicated for the treatment of asthma in patients aged 12 years and older and for the treatment of chronic obstructive pulmonary disease (COPD) in adults, is also available.
Adverse events associated with the use of Symbicort include upper respiratory tract infections, pharyngitis, headaches, and rhinitis.