Healthcare Industry News:  Merck 

Biopharmaceuticals Generics FDA

 News Release - July 14, 2017

Lannett Receives Approval For Cyproheptadine Hydrochloride Syrup, 2 mg/5 mL

PHILADELPHIA, July 14, 2017 -- (Healthcare Sales & Marketing Network) -- Lannett Company, Inc. (NYSE: LCI) today announced that it received approval from the U.S. 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 U.S. 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."

About Lannett Company, Inc.

Lannett Company, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of medical indications. For more information, visit the company's website at

This news release contains certain statements of a forward-looking nature relating to future events or future business performance. Any such statement, including, but not limited to, successfully commercializing Cyproheptadine Hydrochloride Oral Solution, USP, 2 mg/5 mL, and the planned launch of recently approved products, whether expressed or implied, is subject to market and other conditions, and subject to risks and uncertainties which can cause actual results to differ materially from those currently anticipated due to a number of factors which include, but are not limited to, the risk factors discussed in the Company's Form 10-K and other documents filed with the SEC from time to time, including the prospectus supplement related to the proposed offering to be filed with the SEC. These forward-looking statements represent the Company's judgment as of the date of this news release. The Company disclaims any intent or obligation to update these forward-looking statements.

Source: Lannett

Issuer of this News Release is solely responsible for its content.
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