Healthcare Industry News: Novogyne
News Release - August 25, 2008
Noven Provides Update on Daytrana(R) Methylphenidate Transdermal SystemShire Undertakes Voluntary Recall of Two Lots of Daytrana(R) Product
MIAMI--(HSMN NewsFeed)--Noven Pharmaceuticals, Inc. (NASDAQ:NOVN ) today provided an update on the status of Daytrana®, the only transdermal patch indicated for the treatment of the symptoms of Attention Deficit Hyperactivity Disorder (ADHD).
Daytrana®, developed and manufactured by Noven, is licensed globally to Shire Limited. Concurrently with this press release, Shire has announced that it is undertaking a voluntary recall of two lots of Daytrana® product (lots 2819811 and 2764211; NDC number 54092-553-30). Shire is taking this action because Daytrana® patches in these lots do not meet the product’s release liner removal specification and, as a result, patients and caregivers could have difficulties removing the release liner when they peel the patch open.
Shire has advised that, because the voluntary recall is not due to product safety issues, all Daytrana® patches, including those in the lots subject to the recall, can continue to be used unless the release liner cannot be removed, or the patches are damaged while being opened. The Daytrana® prescribing information and medication guide provide that, if a patch is damaged or the release liner is difficult to remove, the patch should be discarded. For additional information on this voluntary recall, see www.daytrana.com.
Peter Brandt, Noven’s President & Chief Executive Officer, commented: “Daytrana continues to bring important benefits to patients with ADHD and, together with Shire, we are committed to resolving the release liner issue. We have identified what we believe is the definitive root cause and are aggressively testing potential solutions that we expect will address the issue. As previously indicated, however, until testing is completed and solutions are implemented, voluntary actions like today’s two lot recall are possible, as we work to assure that patients and caregivers can use Daytrana® with the convenience they expect from this novel ADHD treatment.”
Shire has advised that current supply levels of Daytrana® are expected to be sufficient to ensure that patients can continue to have their Daytrana® prescriptions filled at their local pharmacies. Noven continues to manufacture the product and Shire continues to promote it in the United States.
Important Daytrana® Safety Information
Tell your doctor about any heart conditions, including structural abnormalities, your child or a family member may have. Inform your doctor immediately if the child develops symptoms that suggest heart problems, such as chest pain or fainting. Daytrana® should not be used if the child has: significant anxiety, tension, or agitation; allergies to methylphenidate or other ingredients of Daytrana®; glaucoma; discontinued in the last 14 days or is taking a monoamine oxidase inhibitor (MAOI); tics, or family history or diagnosis of Tourette’s syndrome.
Tell your doctor before using Daytrana® if the child: is being treated for or has symptoms of depression (e.g. sadness, worthlessness, or hopelessness) or bipolar disorder; has family history of tics; has abnormal thoughts or visions, hears abnormal sounds, or has been diagnosed with psychosis; has had seizures or abnormal EEGs; has or has had high blood pressure; exhibits aggressive behavior or hostility. Tell your doctor immediately if the child develops any of these conditions/symptoms while using Daytrana®.
In clinical studies, side effects were generally mild to moderate. The most common side effects reported with Daytrana® were decreased appetite, sleeplessness, sadness/crying, twitching, weight loss, nausea, vomiting, tics, and affect lability (mood swings). Aggression, new abnormal thoughts/behaviors, mania, and growth suppression have been associated with use of drugs of this type. Tell your doctor if the child has blurred vision while using Daytrana®.
Note: Abuse of Daytrana® can lead to dependence. Daytrana® should be applied daily to clean, dry skin, which is free of any cuts or irritation. Skin redness or itching is common with Daytrana®. Allergic skin rash may occur.
Noven Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the research, development, manufacture, marketing and sale of prescription pharmaceutical products. Noven’s business and operations are focused in three principal areas – transdermal drug delivery, the Novogyne joint venture, and Noven Therapeutics, Noven’s specialty pharmaceutical unit.
Safe Harbor Statement under the Private Litigation Reform Act of 1995
Except for historical information contained herein, the matters discussed in this press release contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve substantial risks and uncertainties. Statements that are not historical facts, including statements that are preceded by, followed by, or that include, the words “believes,” “anticipates,” “plans,” “expects” or similar expressions and statements are forward-looking statements. Noven’s estimated or anticipated future results, product performance or other non-historical facts are forward-looking and reflect Noven’s current perspective on existing trends and information. Actual results, performance or achievements could differ materially from those contemplated, expressed or implied by the forward-looking statements contained herein. These forward-looking statements are based largely on the current expectations of Noven and are subject to a number of risks and uncertainties that are subject to change based on factors that are, in many instances, beyond Noven's control.
These risks and uncertainties include: the risk that additional lots of Daytrana® may be recalled by Shire due to product failing to meet the release liner specification or otherwise; the risk that Noven may not be successful in identifying or implementing a solution to resolve the release liner issue; uncertainties related to the financial impact of the recall; the risk that Noven’s response to the FDA’s January 2008 warning letter, which remains under FDA review, may not be acceptable to the FDA or adequately address the FDA’s concerns, and in such case, the risk that the FDA may take regulatory action against Noven, which may include fines, product seizures or recalls, injunctions, suspension of production and/or the withdrawal of product approval; and the risk that any adverse effect to the market for Daytrana® due to the foregoing or other factors could adversely affect Noven’s reputation, results of operations and/or its financial position. For additional information regarding these and other risks associated with Noven’s business, readers should refer to Noven’s Annual Report on Form 10-K for the year ended December 31, 2007, as well as other reports filed from time to time with the Securities and Exchange Commission. Unless required by law, Noven undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
Source: Noven Pharmaceuticals
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