FDA approves Breckenridge’s Megace ES generic

The Food and Drug Administration has approved Breckenridge Pharmaceuticals’ generic of Megace ES (megestrol acetate oral suspension).

The drug is a concentrated suspension that is indicated to treat loss of appetite, severe malnutrition or unexplained significant weight loss in patients with AIDS. The drug had generic and brand sales of $17.6 million for the 12 months ended October 2017, according to IQVIA data.

The Boca Raton, Fla.-based company said the product was launching immediately, having resolved litigation between it, Par Pharmaceuticals and Alkermes Pharma Ireland.