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The Access to Life-Saving Medicine Act re-filed February 2007 ; aims to create an abbreviated pathway for the approval of follow-on biologicals in the US by amending the existing PHSA. The bill would empower the FDA to grant approval to biosimilars based on the ability to show comparability in terms of purity, safety and potency to the reference product. Specifically, the molecular structures of the biosimilar and reference product must be highly similar and have the same mechanism of action, route of administration, dosage form, strength and at least one common indication on the label. The bill provides for marketing exclusivity to be granted to products that are deemed interchangeable with reference products, thus rewarding those companies prepared to undertake costly trials to support their products. The bill also contains provision to limit the duration of patent disputes and to set clear time-frames for FDA response times. The latter provision is controversial, since the eight-month timeframe for review would be quicker than a standard review for a new chemical entity and on a par with priority reviews, yet the only differentiating factors for these products against existing products would be price. While the bill is clearly a further step towards creation of a biosimilars pathway in the US, it has several political hurdles to surpass and will be dependent on the FDA being able to create clear guidelines on the studies required to gain approval and provide adequate post-marketing safety surveillance. FDA Commissioner Andrew von Eschenbach stated in March 2007 that an end-point of similarity could be achieved, but that biosimilars would not be freely substitutable with the brand-name product. Increasingly, brand-name pharmaceutical companies are turning to authorised generics as a means of dampening the impact of patent expiry in the US, by taking profit away from the generic manufacturer that has been awarded 180 days' exclusivity by the FDA. At present, there is nothing to stop a brand manufacturer from launching its own generic or granting a licence to a third party to launch an authorised generic either before the loss of exclusivity or during the 180-day exclusivity period. Wood Mackenzie Page 4 Executive's Guide 2007 and lotensin. LEVAQUIN is indicated for adults with acute bacterial sinusitis due to S. pneumoniae, H. influenzae, or M. catarrhalis.
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Conclusions: Triggering characteristics and involved body parts are helpful in discriminating cataplexy-like symptoms from true cataplexy. References: 1 ; Mignot E, Hayduk R, Black J, Grumet FC and Guilleminault C. HLA DQB1 * 0602 is associated with cataplexy in 509 narcoleptic patients. Sleep 1997; 20 11 ; : 1012-1020. 552.K SPECT Investigations of Striatal Dopamine Transporters in Narcolepsy Eisensehr I, 1 Linke R, 2 Tatsch K, 2 v Lindeiner H, 1 Trenkwalder C, 3 Wetter TC, 3 Eberle R, 4 Schuld A, 3 Pollmaecher T, 1 Noachtar S2 1 ; Department of Neurology, University of Munich, Germany, 2 ; Department of Nuclear Medicine, University of Munich, Germany, 3 ; Max Planck Institute of Psychiatry, Munich, Germany, 4 ; Department of Internal Medicine, Rotkruz-Clinic, Munich, Germany Introduction: The pathophysiological basis of narcolepsy is still unknown. Autoradiographic studies of post-morten human narcoleptic patients revealed increases of D2-receptor binding in the basal ganglia. In vivo single-photon emission computed tomography SPECT ; and positron emission tomography PET ; studies in narcolepsy revealed no abnormalities of striatal postsynaptic D2-receptor binding. Presynaptic striatal dopaminergic function has not been evaluated in narcolepsy so far. Methods: We therefore studied striatal presynaptic dopamine transporters with N ; - 3-iodopropene-2-yl ; -2beta-carbomethoxy-3beta- 4chlorophenyl ; tropane 123I-IPT ; using SPECT in drug-free patients with narcolepsy n 10 ; and 10 age- and sex-matched controls without a history of sleep disorders. Results: There was no statistical difference in IPT-binding between patients and controls. Narcoleptic patients showed a wider variance of IPT-binding than controls. Three of the four patients with the lowest IPTbinding values were pretreated with modafinil n 2 ; and amphetamins n 1 ; , which were discontinued at least 5 days prior to the SPECT. There were significant negative correlations Spearman correlation coefficient 0.68, p 0.030 ; of age and duration of the disease with IPT-binding of every investigated striatal area only in narcoleptics. I was readin about levaquin and doxycylcin and levothroid. Prostaglandin Agonists Lumigan Travatan Xalatan Prostaglandin Agonists Drugs Requiring MEDICAL JUSTIFICATION Rescula Quinolones Second Generation ; Ciprofloxacin Ofloxacin Quinolones Second Generation ; Drugs Requiring MEDICAL JUSTIFICATION Cipro * Cipro XR Floxin Maxaquin Noroxin Quinolones "Respiratory" Third Generation ; Levaquin levofloxacin ; Quinolones "Respiratory" Third Generation ; Drugs Requiring MEDICAL JUSTIFICATION Avelox Tequin Sedative Hypnotics Ambien Estazolam Flurazepam HCL Temazepam Triazolam Sedative Hypnotics Drugs Requiring MEDICAL JUSTIFICATION Dalmane * Doral Halcion * Prosom Restoril * Restoril 7.5mg Sonata.