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Following a public comment period, the Federal Trade Commission has approved a final order settling charges that ANI Pharmaceuticals, Inc.’s $210 million acquisition of Novitium Pharma LLC violated federal antitrust laws.

First announced in November 2021, the complaint alleged that the acquisition as proposed likely would have harmed competition in the U.S. markets for generic SMX-TMP oral suspension, an antibiotic used to treat infections, and generic dexamethasone tablets, an oral steroid product used to treat inflammation associated with a variety of conditions.

The final order requires ANI and Novitium to divest ANI’s rights and assets to generic SMX-TMP oral suspension and generic dexamethasone tablets to Prasco LLC within 10 days after the acquisition is final. The final order also contains a prior approval provision that gives the Commission notice and approval rights for future related acquisitions in these markets.

The Commission vote to approve the final order was 4-0.  

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Kari Wallace
Bureau of Competition