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 The company's shares fell 19 percent to $15 in after-market trading
on Monday, recovering from a 24 percent drop earlier.
The FDA has not provided any information regarding the nature of the
deficiencies, the company said.
The notification does not reflect a final decision on the
information under review, the FDA said in a Oct. 16 notification to
the company.
Neos Therapeutics' drug, Cotempla XR-ODT, aims to treat attention
deficit hyperactivity disorder (ADHD), a condition which includes
symptoms such as poor concentration, hyperactivity and learning
difficulties.
The disorder affects about 4.1 percent American adults aged 18 years
and older in a given year and 9 percent of children aged 13-18
years, according to the National Institute of Mental Health.
The FDA was expected to make a decision on the drug by Nov. 9.
The company said it will coordinate closely with the health
regulator to understand the nature of the deficiencies and work to
resolve them as quickly as possible.
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Through Monday's close, shares of the company, which debuted on July
23, had risen about 24 percent from its IPO price.
(Reporting By Samantha Kareen Nair in Bengaluru; Editing by Sriraj
Kalluvila)
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