Amneal Receives U.S. FDA Approval for Ciprofloxacin and Dexamethasone Otic Suspension

Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”) today announced it has received Abbreviated New Drug Application (“ANDA”) approval from the U.S. Food and Drug Administration (“FDA”) for ciprofloxacin and dexamethasone otic suspension. This product is a combination of ciprofloxacin, a fluoroquinolone antibacterial and dexamethasone, a corticosteroid, and is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult, and elderly patients due to staphylococcus aureus and pseudomonas aeruginosa.

“This approval represents the addition of another complex, high value medicine,” said Andy Boyer, Executive Vice President, Chief Commercial Officer - Generics. “It reflects the ongoing shift of our leading affordable medicines portfolio towards complex products and the continued successful diversification of our business.”

The most common adverse reactions reported with ciprofloxacin and dexamethasone otic suspension were ear pain (2.3%), ear discomfort (3%), and ear pruritus (1.5%). For full prescribing information, see package insert located here.

About Amneal

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global pharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 270 pharmaceutical products, primarily within the United States. In its Generics segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com.

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