FDA Approves Sandoz Inc ANDA for Rexulti Generic Brexpiprazole

Sept. 27, 2022, 4:38 PM UTC

The FDA approved Sandoz Inc’s ANDA for Brexpiprazole tablets, a generic version of Otsuka Pharmaceutical’s Rexulti.

  • Brexpiprazole tablets between 0.25 mg and 4 mg approved
  • “With this approval, Sandoz may be eligible for 180-days of shared generic drug exclusivity for Brexpiprazole Tablets”

NOTE

  • Novartis AG rose 0.6% to CHF74.39 as of last close
    • The average 12-month price target of CHF90.20 is 21.3% above the current price
    • 17 buys, 12 holds, 4 sells

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To contact the reporter on this story:
Zac Fleming in New York at zfleming2@bloomberg.net

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