LONDON – Pharmaceutical company Shire PLC said Thursday that the U.S. Food and Drug Administration indicated that it may approve the company's Intuniv treatment for attention-deficit hyperactivity disorder for children.
The FDA has also requested additional information on the treatment, Shire which also makes the attention deficit hyperactivity disorder drug Adderall said in a statement.
Unlike some ADHD treatments, the company said, Intuniv a nonstimulant is not a controlled substance and does not have a known mechanism for potential abuse or dependence.
"The FDA's approvable letter for Intuniv is positive news, and Shire will be working closely with the agency to address its questions," said Chief Executive Matthew Emmens.
Shire shares dipped 1.3 percent to 1,204 pence ($23.97) on the London Stock Exchange.
The company said Wednesday that it entered an agreement with Renovo Group PLC to develop that company's Juvista anti-scarring treatment.