Breckenridge Pharmaceutical awarded final US FDA approval for Megestrol Acetate Oral Suspension ANDA
5 December 2017 -

Pharmaceutical company Breckenridge Pharmaceutical Inc reported on Monday the receipt of final approval from the US Food and Drug Administration for its Abbreviated New Drug Application for Megestrol Acetate Oral Suspension for the treatment of anorexia.

The company said the Megestrol Acetate Oral Suspension is the generic version of MegaceES by Strativa Pharmaceuticals, a division of Par Pharmaceutical Inc.

Following the successful Paragraph IV litigation with Par Pharmaceutical Inc and Alkermes Pharma Ireland Limited under its aggressive Paragraph IV strategy, Breckenridge will launch its ANDA with immediate effect upon approval.

According to the company, Megace ES (megestrol acetate) is a concentrated suspension indicated for the treatment of anorexia (loss of appetite), cachexia (severe malnutrition), or an unexplained, significant weight loss in people with a diagnosis of AIDS.

Annually, Megace ES has generated combined sales of USD17.6m, according to October 2017 IMS Health sales data.