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FDA Approves Katerzia

FDA Approves Katerzia (amlodipine) Oral Suspension for Pediatric Patients 6 Years of Age and Older

WOBURN, Mass. (July 10, 2019) – Azurity Pharmaceuticals, a specialty pharmaceutical company that makes safe, high-quality treatments for patients requiring customized formulations for their care, announced today that the U.S. Food and Drug Administration (FDA) has approved Katerzia (amlodipine) Oral Suspension, 1 mg/mL, the first and only FDA-approved amlodipine oral suspension. Katerzia is indicated for the treatment of hypertension (high blood pressure) in adults and pediatric patients 6 years of age and older and coronary artery disease in adults.

“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

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® Unit-of-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.

Source: Azurity Pharmaceuticals

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