UCB's Kremers Urban Pharmaceuticals Inc. receives FDA approval for extended release methylphenidate hydrochloride
- Extended release methylphenidate hydrochloride product is bioequivalent to Concerta QD®
- 18mg and 27mg extended release methylphenidate hydrochloride product approved
- Tentative approval for the 36mg and 54 mg
Brussels and Princeton, NJ 10 July 2013 - regulated information– UCB announced today that Kremers Urban Pharmaceuticals Inc. (KU), its U.S. subsidiary focused on specialty generics, received approval from the U.S. Food and Drug Administration (FDA) for 18mg and 27mg extended release methylphenidate hydrochloride product, for which Concerta® is the reference listed drug product. KU has begun launch operations and supplying the US-market with the product. KU also received tentative approval for the 36mg and 54 mg. KU will be eligible for final approval after exclusivity expiration in September 2013.
KU's extended release methylphenidate hydrochloride product is bioequivalent to Concerta QD® marketed by ALZA Corporation (a unit of Johnson & Johnson). Each tablet is designed to be effective for 12-hours.
In September 2011, KU announced that it has reached a settlement dismissing all pending litigation arising from its Abbreviated New Drug Application (ANDA) to market an extended release methylphenidate hydrochloride product. The settlement allows Kremers Urban to commercially launch its methylphenidate ANDA product under the existing Alza Corporation patents.
The launch of KU's new generic product was already considered in UCB's 2013 financial guidance.
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Notes to the editor
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 8 500 people in about 40 countries, the company generated revenue of EUR 3.4 billion in 2012. UCB is listed on Euronext Brussels (symbol: UCB).
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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