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Aurobindo gets FDA approval for fluoxetine tablets

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EAST WINDSOR, N.J. – Aurobindo  has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application fluoxetine tablets, 10 mg and 20 mg. Aurobindo’s fluoxetine tablets, 10 mg and 20 mg are an AB-rated generic equivalent to the reference listed drug, Prozac Tablets of Eli Lilly and Co.

Fluoxetine is a selective serotonin reuptake inhibitor indicated for:

  • Acute and maintenance treatment of Major Depressive Disorder (MDD) in adult and pediatric patients aged 8 to 18 years.
  • Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adults and pediatric patients aged 7 to 17 years.
  • Acute and maintenance treatment of Bulimia Nervosa in adult patients.
  • Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients.

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