PRINCETON, N.J., Nov. 14, 2014 /PRNewswire/ -- 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Food and Drug Administration (FDA) that the agency requests an additional bioequivalence study based on recently issued draft guidance to confirm the therapeutic equivalence of the company's methylphenidate hydrochloride extended-release (ER) tablets (CII) to the category reference drug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 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
UCB U.S. Communications: Kristie Madara, 1-770-970-8726, email@example.com
About Kremers Urban Pharmaceuticals Inc. (KU)
KU is the generic subsidiary of UCB in the U.S. It is a specialty generic pharmaceutical company focused on difficult, "high barrier to entry" generic products. To learn more visit www.kremersurban.com.
Forward looking statements
This press release contains forward-looking statements based on current plans, estimates and beliefs of management. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, political, regulatory or clinical results and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions which could cause actual results to differ materially from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms, costs associated with research and development, changes in the prospects for products in the pipeline or under development by Kremers Urban, effects of future judicial decisions or governmental investigations, product liability claims, challenges to patent protection for products or product candidates, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws and hiring and retention of its employees.
Additionally, information contained in this document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction. Kremers Urban is providing this information as of the date of this document and expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report a change in its expectations.
There is no guarantee that new product candidates in the pipeline will progress to product approval or that new indications for existing products will be developed and approved. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences between the partners. Also, Kremers Urban or others could discover safety, side effects or manufacturing problems with its products after they are marketed.
Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement.
SOURCE Kremers Urban Pharmaceuticals Inc.