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FDA Approves CaroSpir

CMP Pharma, Inc. Announces FDA Approval of CaroSpir (spironolactone) Oral Suspension

Farmville, NC. August 7, 2017 – CMP Pharma today announced that the US Food and Drug Administration (FDA) has granted final approval of the company’s New Drug Application (NDA) for CaroSpir (Spironolactone Oral Suspension, 25 mg/5mL), the first and only FDA-approved oral liquid dosage form of the potassium-sparing diuretic spironolactone.

“CaroSpir provides a stable, ready to use and consistent liquid treatment option for adult patients, including those who have difficulty swallowing, or who cannot swallow tablets,” said Gerald Sakowski, CEO at CMP Pharma, Inc. “Up until now, these patients have been prescribed a pharmacy compounded liquid form of spironolactone. The dosing inconsistencies of compounded liquids have long been a persistent challenge for physicians.”

CaroSpir will be introduced early in the fourth quarter of 2017. For more information, contact CMP Pharma at 252-753-7111, or visit CaroSpir.com.

About CaroSpir

CaroSpir (spironolactone oral suspension) is indicated for treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema and to reduce the need for hospitalization for heart failure, and is usually administered in conjunction with other therapies. CaroSpir is also indicated for use as an add-on therapy for the treatment of hypertension, to lower blood pressure in adult patients who are not adequately controlled on other agents, and as part of comprehensive cardiovascular risk management. Lastly, CaroSpir is indicated for the management of edema in adult cirrhotic patients when edema is not responsive to fluid and sodium restriction.

CaroSpir is contraindicated for patients with the following conditions: hyperkalemia, Addison’s disease, and concomitant use of eplerenone.

About CMP Pharma, Inc.

CMP Pharma is a specialty pharmaceutical company that addresses critical needs for niche markets by developing and manufacturing a portfolio of high value liquid and semi-solid pharmaceutical products. CMP Pharma combines decades of experience in pharmaceutical development and manufacturing to provide medicines to fill the unmet medical needs of many patients.

ADDITIONAL IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

CaroSpir is contraindicated for patients with the following conditions:

  • Hyperkalemia
  • Addison’s disease
  • Concomitant use of eplerenone

WARNINGS AND PRECAUTIONS/ADVERSE REACTIONS

CaroSpir may cause the following conditions:

  • Hyperkalemia
  • Hypotension and Worsening Renal Function
  • Electrolyte and Metabolic Abnormalities
  • Gynecomastia
  • Impaired neurological function/coma in patients with hepatic impairment, cirrhosis and ascites

The most common adverse reaction (incidence > 5%) with CaroSpir treatment is the increased occurrence of gynecomastia in men.

Talk to your healthcare provider about other possible side effects with CaroSpir. To report SUSPECTED ADVERSE REACTIONS, contact CMP Pharma, Inc. at 1-844-321-1443, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.

ADMINISTRATION

CaroSpir oral suspension, 25 mg/5 mL, is not therapeutically equivalent to tablet forms of spironolactone. Follow dosing instructions for CaroSpir. In patients requiring a dose greater than 100 mg, use another formulation of spironolactone. Doses of CaroSpir suspension greater than 100 mg may result in spironolactone concentrations higher than expected.

Source: CMP Pharma

Posted: August 2017

CaroSpir (spironolactone) FDA Approval History

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