Neos Therapeutics Says ADHD Drug Cotempla XR-ODT Gets FDA Approval

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( - Neos Therapeutics, Inc. ( NEOS ), a pharmaceutical company focused on extended-release or XR products, announced Tuesday that the U.S. Food and Drug Administration approved Cotempla XR-ODT.

It is the first and only methylphenidate extended-release orally disintegrating tablet for the treatment of attention-deficit/hyperactivity disorder or ADHD in patients 6 to 17 years old.

The company noted that Cotempla XR-ODT will be commercially available in a portable, child-resistant blister pack in the fall of 2017.

Cotempla XR-ODT and Adzenys XR-ODT are Schedule II controlled substances.

Vipin Garg, President and CEO of Neos Therapeutics, said, "With this approval, Neos will be the only company to have both a branded methylphenidate and a branded amphetamine product available in an extended-release orally disintegrating tablet dosage form. We look forward to having Cotempla XR-ODT join our Adzenys XR-ODT (amphetamine) extended-release orally disintegrating tablets on the market this fall."

On Nasdaq, Neos shares gained 4.05 percent in the regular trading and settled at $9. In the after hours, the shares meanwhile declined 7.8 percent to $8.30.

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This article appears in: World Markets , Stocks
Referenced Symbols: 3627 , NEOS

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