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PHILADELPHIA, Aug. 18, 2015 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that its Silarx Pharmaceuticals, Inc. subsidiary has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Aripiprazole Oral Solution 1 mg/mL, the generic version of the antidepressant drug ABILIFY®. According to IMS, annual total sales of Aripiprazole 1 mg/ml Oral Solution at Average Wholesale Price (AWP) were approximately $76 million. The FDA website reports certain formulations of ABILIFY®, including the oral solution 1 mg/mL dosage, have been discontinued by the brand manufacturer.
"Our generic Aripiprazole 1 mg/ml Oral Solution product is one of two to be approved by FDA; shipping of this important medication has commenced," said Arthur Bedrosian, chief executive officer of Lannett. "This approval is the first from our recently completed acquisition of Silarx."
Important Safety Information
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS WITH ANTIDEPRESSANT DRUGS
See full prescribing information for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ABILIFY is not approved for the treatment of patients with dementia-related psychosis. Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants. Monitor for worsening and emergence of suicidal thoughts and behaviors.
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 www.lannett.com.
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 Aripiprazole 1 mg/ml Oral Solution, 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.
