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Lannett Co. (LCI) Gets FDA Approval, Stock Soars 10.5%

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Lannett Company, Inc. stock rose 10.5% Monday on an official announcement that the company had recently gotten FDA approval of an Abbreviated New Drug Application (ANDA). The approval is for the company’s Paroxetine Extended Release Tablets, an anti-depressant.

An ANDA is an application for U.S. generic drug approval for medication that has already been approved or licensed by the FDA. With approval, the applicant for the ANDA gains the right to manufacture the generic version of the drug and in turn offer a cheaper alternative to consumers.

As per LCI’s official statement, Paroxetine is the first major approval from their Kremers Urban subsidiary, which they acquired eight months ago.

Analysts have not revised LCI’s earnings estimates in the last 60 days. Current estimates sit at earnings of $0.73 per share for the current fiscal quarter and at $3.53 per share for their next fiscal year, which for LCI began on July 1st.

CEO Arthur Bedrosian maintains a positive outlook ahead of the next earnings report date of August 23rd, stating that Paroxetine currently only has one other generic competitor on the market. LCI has also received approval for six other products recently.

Lannett Co. currently sits at a Zacks Rank #3 (Hold).

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