BRIDGEWATER, N.J. - Amneal Pharmaceuticals, Inc. (NASDAQ: NASDAQ:AMRX) has announced the FDA approval of its generic ciprofloxacin and dexamethasone otic suspension, a medication intended for the treatment of certain ear infections.
This recent approval by the U.S. Food and Drug Administration marks the addition of another complex, high-value product to Amneal's portfolio, which is known for its focus on affordable medicines.
The approved drug is a combination of ciprofloxacin, a fluoroquinolone antibacterial, and dexamethasone, a corticosteroid, formulated to treat Acute Otitis Externa (AOE) in patients aged six months and older. AOE, commonly referred to as swimmer's ear, is an infection of the outer ear canal caused by bacteria, such as staphylococcus aureus and pseudomonas aeruginosa.
Andy Boyer, Executive Vice President and Chief Commercial Officer - Generics at Amneal, emphasized the significance of the approval, stating it aligns with the company's strategy to diversify its business by expanding into complex product categories.
The company, headquartered in Bridgewater, New Jersey, has a growing portfolio that includes over 270 pharmaceutical products, with a strong presence in generics, injectables, biosimilars, and branded pharmaceuticals.
The company's press release detailed the most common adverse reactions to the ciprofloxacin and dexamethasone otic suspension, including ear pain, ear discomfort, and ear pruritus. For more detailed prescribing information, healthcare professionals are directed to the product's package insert.
Amneal Pharmaceuticals has not only established itself in the generics market but also in branded pharmaceuticals, primarily focusing on central nervous system and endocrine disorders. Additionally, through its AvKARE segment, Amneal serves as a distributor for the U.S. federal government, retail, and institutional markets.
This announcement is based on a press release statement and does not endorse the claims made. It provides factual information about the FDA's approval of Amneal's new drug and the company's position in the pharmaceutical industry.
For further details on the company's performance, financial results, and market positioning, investors are referred to the company's filings with the Securities and Exchange Commission.
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