Generic Megace ES Launched
August 3, 2015 - TWi Pharmaceuticals announced the launch of its AB-rated generic to Par’s Megace ES (megestrol acetate oral suspension) 625mg/5ml. Indications for this drug include the treatment of appetite loss, severe malnutrition (cachexia), or an unexplained significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS).
The U.S Food and Drug Administration (FDA) also granted TWi 180 days of generic exclusivity; meanwhile Par is marketing an authorized generic. Based on IMS Health data, for the 12 months ending in May of 2015, U.S. sales for Megace ES were approximately $44 million.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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