UCB's Kremers Urban Pharmaceuticals Inc. informed by U.S. FDA of ANDA reclassification of methylphenidate ER
Princeton, NJ - Nov. 14, 2014– Kremers Urban Pharmaceuticals Inc. (KU) has been informed by the U.S. Food and Drug Administration (FDA) that the agency requests an additional bioequivalence study based on recently issued draft guidance to confirm the therapeutic equivalence of the company's methylphenidate hydrochloride
extended-release (ER) tablets (CII) to the category reference drug Concerta®. Until additional data is provided, the agency has changed the therapeutic rating for KU's methylphenidate ER from, AB to BX, which means the product is still approved and can be prescribed, but is not recommended as automatically substitutable at the pharmacy for the brand-name drug.
KU intends to perform the requested additional study and will work with the agency in the best interests of the patients. For further questions, patients and healthcare professionals can contact 1-866-822-0068.
Concerta® is a registered trademark of ALZA Corporation
For further information
UCB Investor Relations: Antje Witte, +32.2.559.94.14, firstname.lastname@example.org
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UCB U.S. Communications: Kristie Madara, 1-770-970-8726, email@example.com
About Kremers Urban Pharmacuticals Inc. (KU)
KU is the generic subsidiary of UCB in the US. It is a specialty generic pharmaceutical company focused on difficult, “high barrier to entry" generic products. To learn more visit www.kremersurban.com.
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