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TMCNet:  Amneal Pharmaceuticals Announces Four New Generics

[August 13, 2014]

Amneal Pharmaceuticals Announces Four New Generics

BRIDGEWATER, N.J. --(Business Wire)--

Amneal Pharmaceuticals' fast-growing portfolio of approved generic drugs is expanding once again with the launch of four new medications. Representing multiple therapeutic categories, these products accounted for $900 million annually in U.S. sales as of June 2014, according to IMS Health market data.

Acyclovir ointment, USP is available in 5% strength. Sold in 30-gram tubes, each gram of ointment contains 50 mg of acyclovir. The Amneal generic is an AB-rated therapeutic equivalent to Zovirax® Ointment 5%.

Atovaquone oral suspension, USP, the first-to-market generic, is available in 750 mg/5 mL strength. The bright yellow, citrus-flavored liquid comes packaged in 210 mL (8 fl. oz.) bottles. The Amneal medication is an AB-rated therapeutic equivalent to Mepron® Oral Suspension.

Clindamycin palmitate hydrochloride for oral solution, USP (Pediatric) is available in 75 mg/5 mL reconstituted strength. Mixing the powder with water provides 100 mL of a clear, cherry-flavored solution. The Amneal product is an AA-rated therapeutic equivalent to Cleocin Pediatric®. Click here for full prescribing information.


Oxycodone hydrochloride tablets, USP (C-II) are available in 5 mg, 10 mg, 15 mg, 20 mg, or 30 mg strength in 100-count bottles. The Amneal generic is AB-rated and therapeutically equivalent to Roxicodone®.

These four products are now shipping and available through wholesalers, distributors, and directly to the trade.

"Introducing these four products in the market aligns with our strategic focus on extending our generic offerings across all dosage forms," said Chirag Patel (News - Alert), Co-CEO and Co-Chairman of Amneal. "Currently, we have 125 ANDAs filed with the U.S. FDA across numerous dosage forms, including transdermal, oral liquid, topical, injectable, oral solid, ophthalmic and otic. These new medications will further diversify our expansive portfolio."

About Amneal Pharmaceuticals LLC

Amneal Pharmaceuticals LLC is a U.S.-based manufacturer of generic pharmaceuticals. Known as "Generic's New Generation®", Amneal prides itself on its unwavering commitment to quality, meaningful business relationships, and its innovative approach to maximizing value for all stakeholders. Extensive investment in R&D, an intelligently aggressive expansion strategy, and focus on vertical integration are key contributors to the company's impressive growth over the past several years. Amneal is headquartered in Bridgewater, New Jersey with manufacturing, R&D, packaging, sales and distribution facilities throughout the U.S. as well as abroad. For more information, visit www.amneal.com.

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