logo
Share SHARE
FONT-SIZE Plus   Neg

UCB'Kremers Gets FDA Approval For Extended Release Methylphenidate Hydrochloride

UCB announced Wednesday that its U.S. subsidiary, Kremers Urban Pharmaceuticals Inc. or KU, received approval from the U.S. Food and Drug Administration or 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 54mg. 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 (JNJ). 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 or 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.

UCB noted that the launch of KU's new generic product was already considered in its 2013 financial guidance.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Sony announced Project Field, a new play way to bring card games to life, along with a host of smartphone games at an event in Japan, aiming to accelerate mobile drive. Project Field is a Japan-only card collection platform where actual physical cards will work with a smartphone app. The first title to be announced is based on Yo-kai Watch for mobile. There is no news about an international releas Shares of Credit Suisse Group AG gained around 8 percent in the morning trading in Zurich after the Swiss banking giant raised its group cost savings target, and also confirmed its medium-term 2018 pre-tax income target. It is almost the end of the year. With the exception of a few, many of the biotech stocks, like the following, on which investors had bet big this year have served up only heartbreak. Now, let's take a look at some of the pending clinical trial catalysts of this month, which will make it a December to remember.
comments powered by Disqus
Follow RTT