The Lilly Cares Foundation, Inc., (“Lilly Cares”) a separate nonprofit organization, offers the Lilly Cares Foundation Patient Assistance Program to assist qualifying patients in obtaining certain Lilly medications at no cost. Lilly Cares has helped millions of patients in the United States obtain the Lilly medications they needed in the areas of mental health, diabetes, growth hormone disorders, men's health, osteoporosis, oncology, psoriasis, rheumatology, and migraine prevention through our patient assistance program. It's important to Lilly Cares to make sure that those who can benefit from these medicines have access to them. Lilly Cares offers assistance to help people obtain the Lilly medicines they need. The Lilly Cares Foundation does not charge a fee for participation in Lilly Cares. The Lilly Cares Foundation is not affiliated with third parties who charge a fee for help with enrollment or medication refills. These third parties may reference Lilly Cares without permission. Patients are not required to use a third party who charges a fee to help with enrollment or medication refills. October 19, 2005 -- ROCKVILLE, MD -- Eli Lilly and FDA notified healthcare professionals of revision to the PRECAUTIONS/Hepatotoxicity section of the prescribing information for Cymbalta (duloxetine hydrochloride), indicated for treatment of major depressive disorder and diabetic peripheral neuropathic pain. Postmarketing reports of hepatic injury (including hepatitis and cholestatic jaundice) suggest that patients with preexisting liver disease who take duloxetine may have an increased risk for further liver damage. The new labeling extends the Precaution against using Cymbalta in patients with substantial alcohol use to include those patients with chronic liver disease. It is recommended that Cymbalta not be administered to patients with any hepatic insufficiency.
To continue reading The Pharma Letter please login, subscribe or claim a 7 day free trial subscription and access exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space. US drugmaker Eli Lilly is buying back sole commercialisation rights to Yentreve/Ari Claim (duloxetine) for the treatment of stress urinary incontinence from its partner, German drugmaker Boehringer Ingelheim. The companies had been marketing the agent together outside the USA since it was first appoved in 2004 but, explaining the move, John Lechleiter, Lilly’s President and Chief Operating Officer, said: “Based on our collective experiences to date in the marketplace, both companies believe that the Yentreve/Ari Claim opportunity is best suited and can be best commercialised in markets outside the US with the support of one company. This is about 'right sizing' our investments to address our greatest opportunities and the greatest patient needs.”In addition, Lilly and BI also announced their decision not to seek marketing approval for Yentreve in the USA, following their withdrawal of the original New Drug Application in January last year after regulators said they could not approve the product based on the data package submitted. “The decision not to pursue approval for Yentreve in the US was a difficult one, given the belief both companies share about the importance of SUI as a medical condition and Yentreve's proven ability to address a significant unmet medical need," Lechleiter noted. But under the firms’ original pact formed back in 2002, their agreement to market duloxetine outside the USA for major depressive disorder, diabetic peripheral neuropathic pain and other potential indications, under the trademarks Cymbalta/Xeristar, remains intact. Commenting on the change, Dr Alessandro Banchi, chairman of the Board of Managing Directors at Boehringer Ingelheim, said: “There has been an excellent spirit of collaboration in our alliance with Lilly. Based on this, we are committed to the continued success in our partnership to commercialise duloxetine for indications other than SUI in markets outside the US.”Meantime, a long-term study of more than 200 patients has shown Cymbalta to be as safe and well-tolerated as current routine care comprising one or more drugs for the management of pain caused by diabetic nerve damage.
Cymbalta-PI-v9.0-22Apr2015 1 CYMBALTA ® duloxetine hydrochloride, Lilly NAME OF THE DRUG CYMBALTA ® duloxetine hydrochloride CYMBALTA is a selective serotonin. Duloxetine, an orally active, dual reuptake inhibitor of neuronal serotonin and norepinephrine, is developed by Eli Lilly. Duloxetine shares this mechanism of