FDA OKs Lannett unit's ANDA filing for generic version of ABILIFY

Lannett Company said this week that its Silarx Pharmaceuticals subsidiary received U.S. Food and Drug Administration (FDA) approval of its Abbreviated New Drug Application (ANDA) for Aripiprazole 1 mg/mL Oral Solution, the generic version of the antidepressant drug ABILIFY.

"Our generic Aripiprazole 1 mg/ml Oral Solution product is one of two to be approved by the FDA; shipping of this important medication has commenced," Lannett CEO Arthur Bedrosian said. "This approval is the first from our recently completed acquisition of Silarx."

IMS Health said annual sales of Aripiprazole 1 mg/ml Oral Solution at the average wholesale price total approximately $76 million. The FDA said certain formulations of ABILIFY, including the oral solution 1 mg/mL dosage, have been discontinued by the brand's manufacturer.


Lannett manufactures and distributes high-quality affordable generic medications that are the therapeutic equivalent of the brand-name pharmaceuticals. Their portfolio consists of numerous products across a wide range of therapeutic areas.




Lannett believes that their ability to choose viable products for development, efficiently develop the products, including acquiring applicable regulatory approvals, integrating into certain specialty markets and achieving economies in production are all critical for the company’s success in the generic pharmaceutical industry.