This product approval does not confer the right on Hikma, or any other party, to market this product outside the United States. This product has been approved for marketing in the United States by the US FDA. “We are eager to work with the US Drug Enforcement Administration to obtain adequate supplies of raw materials that would enable Hikma to expediently use its strong US-based manufacturing and distribution capabilities to help address shortages of this essential medicine.”Īccording to IQVIA, US sales of Vyvanse ® were approximately $5.1 billion in the 12 months ending June 30, 2023. “Patients across the US are currently experiencing shortages of ADHD medicines like lisdexamfetamine,” continued Mr. “This launch is the latest example of our ability to successfully deliver on our pipeline and launch new products, expanding access to needed medicines for our customers and their patients.” “We are pleased to have launched our generic version of Vyvanse ® today immediately upon receiving FDA approval, providing one of the first generic versions of this important medicine to patients and health care providers in the US,” said Brian Hoffmann, President, Generics. Lisdexamfetamine is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older and Moderate to Severe Binge Eating Disorder (BED) in adults.
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