The Food and Drug Administration (FDA) granted approval to Neos Therapeutics’s extended release drug, called Adzenys XR-ODT, for attention deficit hyperactivity disorder (ADHD).
It’s a long-acting orally disintegrating tablet prescribed for patients six years and older, and will come in six different types of dosage strengths, adds the company’s official announcement. The drug is “bioequivalent” to the commonly prescribed medication Adderal XR.
Previously, Neos had received a rejection from the FDA for the orally disintegrating version of Ritalin Cotempla XR-ODT, writes FierceBiotech. The FDA requested the company launch a new study to evaluate the bioequivalence of this drug after finding “deficiencies that preclude discussion.”
Adzenys XR-ODT is the first type of extended release tablet to gain U.S. approval, reports Reuters. Estimated shipping dates are projected for the second quarter of 2016.
Filed Under: Drug Discovery