Amneal Receives FDA Approval for Nitrofurantoin Oral Suspension

First Generic to Market

BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, LLC is pleased to announce that it has received U.S. FDA approval to manufacture Nitrofurantoin Oral Suspension in the 25 mg/5 ml strength effective May 13, 2011. Amneal’s generic, the first on the market, is an AA-rated, therapeutically equivalent alternative to Furadantin® (a registered trademark of Shionogi Pharma, Inc.). Annual U.S. sales of Nitrofurantoin Oral Suspension are $40 million according to January 2011 IMS Health market data.

Nitrofurantoin Oral Suspension is an anti-bacterial medication indicated for the treatment of urinary tract infection (UTI). Amneal will sell its generic in 8 oz/230 ml size bottles. The clear yellow, tutti fruitti-flavored liquid does not require refrigeration. Amneal is now shipping Nitrofurantoin, available through wholesalers-distributors as well as directly to the trade.

The oral suspension is produced in Amneal’s Branchburg, NJ facility, which develops and manufactures liquid, nasal spray and topical finished dosage products. Branchburg is one of the company’s five fully cGMP-compliant plants in the United States, which together represent almost 500,000 square feet of production capacity.

“We are excited to launch this First-to-Market (FTM) generic liquid,” said Chirag Patel, Amneal’s President. “Beyond several new blockbuster generic drugs, our pipeline is enhanced with complex, extended release and generic specialty products in a variety of dosage forms. With so many multi-source generic products creating the foundation of Amneal’s offering, this latest FTM product is the next in a long line Amneal expects to launch that will bring unique value to our portfolio.”

Nitrofurantoin Oral Suspension is the latest addition to the Amneal family of superb quality generic drugs in the company’s on-line catalog at www.amneal.com. 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.

Amneal Pharmaceuticals, LLC, with principal offices in Bridgewater, NJ, is a U.S.-based firm that develops, manufactures and distributes generic pharmaceuticals regulated and approved by the U.S. FDA. Known as “Generic’s New Generation,” the company utilizes its newly expanded R&D and manufacturing capabilities to conceive breakthrough developments with lasting impact for a robust product pipeline. Rapid ANDA approvals and diverse product acquisitions are key to Amneal’s aggressive growth strategy, as is the company’s strong commitment to deep customer relationships and maximum value creation. Amneal delivers high quality products, superior service levels and dynamic value throughout the pharmaceutical industry. For more information, visit www.amneal.com.



CONTACT:

Amneal Pharmaceuticals, LLC
Jim Luce
Executive Vice President, Sales & Marketing
Direct: 949-610-8018
Fax: 949-610-8218
[email protected]
www.amneal.com

KEYWORDS:   United States  North America  New Jersey

INDUSTRY KEYWORDS:   Health  Pharmaceutical  FDA

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