Amneal Announces FDA Approval For Spironolactone HCl Tablets

Main Category: Urology / Nephrology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 29 Aug 2010 - 0:00 PDT

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Amneal Pharmaceuticals, LLC is pleased to announce that it has received U.S. FDA approval to manufacture Spironolactone HCl tablets in 25 mg, 50 mg and 100 mg strengths effective July 2, 2010. The Amneal generic is an AB-rated, therapeutically equivalent alternative to Aldactone® (a registered trademark of Pharmacia & Upjohn, Inc., a unit of Pfizer Inc.). Annual U.S. sales of Spironolactone HCl were $91 MM as of December 2009 according to IMS Health market data.

Spironolactone HCl is a synthetic 17-lactone drug that is a renal competitive aldosterone antagonist in the class of pharmaceuticals known as potassium-sparing diuretics. It is indicated in the management of primary hyperaldosteronism, edematous conditions (for patients with congestive heart failure, cirrhosis of the liver accompanied by edema and/or ascites, the nephritic syndrome), essential hypertension, hypokalemia and severe heart failure (NYHA class III-IV).

Amneal began shipping Spironolactone HCl in 100- and 500-count sizes on July 21, 2010. The 25 mg strength can also be ordered in 1000-count size. This product is available through wholesalers-distributors as well as directly to the trade. The tablets are produced in the company's fully cGMP-compliant Hauppauge, NY facility. Amneal manufactures all of its own generics in the USA and continues to expand its U.S.-based production.

Spironolactone HCl is the most recent addition to Amneal's rapidly growing portfolio, listed in the company's on-line catalog of 250 products here. Launched one year ago, the comprehensive web catalog is designed for easy customer and patient access to essential information, images and literature such as product outserts, labels, patient medication guides, MSDS (material safety data sheets) and high-resolution product photos.

Source:
Amneal Pharmaceuticals, LLC

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