FDA Approves Katerzia™, the First and Only Amlodipine Oral Suspension, 1 mg/mL, for Pediatric Patients 6 Years of Age and Older
“We are pleased to announce the FDA approval of Katerzia”, said Neal Muni, MD, MSPH, President and Chief Executive Officer of Azurity Pharmaceuticals. “The addition of Katerzia complements our existing pediatric hypertension portfolio and will strengthen the overall offering from Azurity. It is also our first product approval since CutisPharma and Silvergate Pharmaceuticals came together to make Azurity Pharmaceuticals, making this a truly exciting time.”
Katerzia offers a ready-to-use (simply shake) oral suspension for children 6 years of age and older that require or prefer an oral liquid option of amlodipine. Appropriate dosing for children is now simple, safe, and effective, while providing the assurance of quality as an FDA-approved product. Katerzia will be readily available through an extensive network of pharmacies and a qualified mail order service. For additional information on Katerzia, please email email@example.com.
About Azurity Pharmaceuticals
Azurity Pharmaceuticals is a privately-held, specialty pharmaceutical company formed by the acquisition of Silvergate Pharmaceuticals, Inc. by CutisPharma, Inc., in May 2019. Azurity focuses on the needs of patients requiring customized, user-friendly drug formulations, especially children and the elderly. Azurity’s products, including Epaned® (enalapril maleate) Oral Solution, Qbrelis® (lisinopril) Oral Solution, Xatmep® (methotrexate) Oral Solution, FIRVANQ® (vancomycin hydrochloride) for Oral Solution, and FIRST® Unitof-Use Compounding Kits, have benefited millions of patients who are unable to swallow conventional oral dosage forms such as tablets and capsules and whose needs are not served by other commercially available therapies. For more information, visit www.azurity.com.