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Lannett gets US FDA approval for cyproheptadine hydrochloride syrup

Saturday, July 15, 2017, 18:00 Hrs  [IST]

Lannett Company, Inc.has received approval from the US Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for cyproheptadine hydrochloride syrup (Cyproheptadine Hydrochloride Oral Solution, USP) 2 mg/5 mL, the therapeutic equivalent to the reference standard drug, cyproheptadine hydrochloride syrup (Cyproheptadine Hydrochloride Oral Solution USP) by Lyne Laboratories, Inc.  The product was previously marketed under the brand name Periactin syrup, 2 mg/5 mL of Merck and Co., Inc.  

For the 12 months ended May 2017, total US sales of cyproheptadine hydrochloride syrup, 2 mg/5 mL, at Average Wholesale Price (AWP) were approximately $6 million, according to IMS.

"The approval of cyproheptadine hydrochloride syrup expands our portfolio of medications in liquid dosage form," said Arthur Bedrosian, chief executive officer of Lannett.  "Through our wholly owned subsidiary, Silarx Pharmaceuticals, we develop and manufacture oral solution drug products, which differentiates 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."

Lannett Company, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of medical indications. 


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