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Issue 15 - 1 October 2004
MSD has voluntarily withdrawn its 'COX-2 selective NSAID' rofecoxib (Vioxx/VioxxAcute). This follows clinical trial results showing an increased risk of confirmed serious thrombotic events (including myocardial infarction and stroke) compared to placebo, following long-term use. The European Pharmacopoeia would like to receive information on Glycerol monostearate 40-55. The enquiry form is available on the website and replies are requested before 15 December 2004. Patent expiry Due to complexity of patent protection, the dates given below are for guidance only. Halofantrine Sept 2004 Propiverine Sept 2004 Clarithromycin Nov 2004 Epoetin alpha/beta Dec 2004 Fluticasone Mar 2005 Interferon gamma Dec 2004 Lercanidipine Jan 2005 Lodoxamide Dec 2004 Ondansetron Feb 2005 New products launched 1. Yentreve (duloxetine) 20mg and 40mg capsules. Duloxetine is a combined serotonin and norepinephrine reuptake inhibitor and is licensed for women with moderate to severe urinary incontinence. 2. Vesicare (solifenacin succinate) 5mg and 10mg film coated tablets . This is a new urinary antispasmodic indicated for the symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome. 3. Myfortic (mycophenolate sodium) 180mg and 360mg film coated tablets. Myfortic is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in adults receiving allogeneic renal transplants. Myfortic is claimed to be a safer alternative to CellCept (mycophenolic mofetil- MMF), as it delivers the active ingredient directly to the small intestine rather than the stomach, enhancing both its absorption and safety profile. 4. Novolizer budesonide (budesonide 200mcg/dose dry powder inhaler). This breath-actuated inhaler is indicated for patients with persistent asthma. 5. Dermol (antibacterial) cream - New formulation The Dermol range now includes a cream formulation. It is licensed for the management of dry and pruritic skin conditions especially eczema and dermatitis and is suitable for direct application or use as a soap substitute. MHRA reminder to MA Holders Marketing authorisation (MA) holders are reminded to update their licences by changing British Approved Names (BANs) to recommended International Nonproprietary Names (rINNs) where applicable. The changes in names of declared active ingredients should be effected by submission of variations by 1 December 2004. ======================== |
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