Lannett Co. Inc. of Philadelphia has obtained FDA approval of its Abbreviated New Drug Application (ANDA) for Cyproheptadine Hydrochloride Syrup (Cyproheptadine Hydrochloride Oral Solution, USP) in 2 mg/5 mL dosage form.
The product serves as the therapeutic equivalent of Cyproheptadine Hydrochloride Syrup (Cyproheptadine Hydrochloride Oral Solution USP), company representatives noted, a solution marketed by another manufacturer [Lyne Laboratories] and previously sold under a different brand name.
"The approval of Cyproheptadine Hydrochloride Syrup expands our portfolio of medications in liquid dosage form," Lannett CEO Arthur Bedrosian said. "Through our wholly owned subsidiary, Silarx Pharmaceuticals, we develop and manufacture oral solution drug products, [differentiating] Lannett from other generic drug companies. In addition, oral solution products address the needs of the aging baby boomer population and are a key driver of our growth strategy. Over the last two months, we have received six product approvals."
Cyproheptadine Hydrochloride Syrup acts as an antihistamine and may be used to treat allergy symptoms such as cough, rhinitis, nasal congestion, sneezing, watery eyes, and itchy nose, eyes or throat. The medication, also an antiserotonergic agent, may be used in the case of migraine headaches or to reduce other allergic reactions.
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