August 19, 2015
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FDA approves abbreviated new drug application for generic Abilify
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Lannett Company Inc. recently announced that its subsidiary, Silarx Pharmaceuticals Inc., received FDA approval for its abbreviated new drug application for aripiprazole oral solution.
The aripiprazole oral solution 1 mg/mL is the generic version of Abilify (Otsuka America Pharmaceutical Inc.).
Annual total sales of aripiprazole oral solution at average wholesale price were approximately $76 million, according to IMS.
“Our generic aripiprazole 1 mg/mL oral solution product is one of two to be approved by FDA [and] shipping of this important medication has commenced,” Arthur Bedrosian, JD, CEO of Lannett, said in a press release. “This approval is the first from our recently completed acquisition of Silarx.”