May 2021: Rx Product News
This month's featured products include dapagliflozin, naloxone hydrochloride spray, and short ragweed pollen allergen extract.
Manufactured by AstraZeneca
The FDA has approved dapagliflozin for the treatment of chronic kidney disease in patients at risk, either with or without type 2 diabetes. The approval follows the priority review designation granted by the FDA earlier in 2021 and is based on positive results from the Dapa-CKD phase 3 trial (NCT03036150). It is not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or individuals who require, or have a recent history of, immunosuppressive therapy for kidney disease.
For more information: astrazeneca-us.com
Naloxone Hydrochloride Nasal Spray (Kloxxado)
Manufactured by Hikma Pharmaceuticals
The FDA has approved an 8-mg dose of naloxone hydrochloride nasal spray for the emergency treatment of known or suspected opioid overdose in adult and pediatric patients. This is a higher dose than in the previously approved products (2-mg and 4-mg dosages). The product is an opioid antagonist that reverses the effects of opioids, including hypotension, respiratory depression, and sedation. If administered quickly, it can usually reverse effects within minutes.
For more information: hikma.com
Short Ragweed Pollen Allergen Extract (Ragwitek)
Manufactured by ALK
ALK's short ragweed pollen allergen extract has received FDA approval for the treatment of patients aged 5 to 65 years with short ragweed pollen-induced allergic rhinitis. The product was first launched in the United States for adult use in 2014. Ragweed pollen is a common cause of seasonal allergies, with ragweed pollen occurring between August and November across the United States. The allergen is indicated as an immunotherapy for the treatment of allergic rhinitis caused by short ragweed pollen, either with or without conjunctivitis, and confirmed by a positive skin test or in vitro testing for pollen-specific IgE antibodies.
For more information: alk.net
Mirabegron Extended-Release Tablets (Myrbetriq)
Manufactured by Astellas Pharma US, Inc
Mirabegron extended-release tablets and granules have received FDA approval to treat children 3 years and older who have neurogenic detrusor overactivity, a bladder dysfunction that results from congenital conditions, such as spina bifida or other diseases, as well as injury in the nervous system. The bladder dysfunction causes overactivity in the bladder wall muscle, which normally relaxes to allow storage of urine. The efficacy of mirabegron tablets and granules for pediatric populations was established in a study of 86 patients, which found improvements in participants' maximum cystometric capacity, number of detrusor contractions, and volume of urine held until first detrusor contraction, as well as the number of daily urine leakage episodes after 24 weeks of treatment.
For more information: myrbetriq.com