Since long this battle of patent linkage in india is going on between Bayer and Cipla and DCGI. After filing appeal in high court by Bayer the highcourt had dismissed the appeal by Bayer Corporation, seeking the introduction of patent linkage system in India. After this decision, Bayer raised his voice in supreme court, but same decision was given by supreme court and rejected the special leave petition filed by Bayer.
Patent linkage means if a product patent of any molecule is granted in india then DCGI should refuse or delay the approval of generic version of that drug until the expiry of the said product patent. If patent linkage system will be allowed the generic player can not come in the market early and due to that people have to pay high price of branded drugs. So ultimately people will suffer from this. Therefore the supreme court has also rejected the patent linkage system in india.
Showing posts with label Bayer. Show all posts
Showing posts with label Bayer. Show all posts
Thursday, December 2, 2010
Friday, September 10, 2010
Bayer has received European approval for a new formulation of Levitra (vardenafil HCI)
Bayer claimed that Levitra 10mg orodispersible tablet is expected to be the first ED medication available in this new and convenient formulation.
Levitra 10mg orodispersible tablet is expected to allow men a discreet and convenient intake without water, dissolving on the tongue within seconds with a minty flavour.
Levitra 10mg orodispersible tablet has received approval based on the results from Phase III multinational trials Potent I and II which compared the efficacy and safety of 10mg vardenafil orodispersible tablet with placebo after 12 weeks of treatment in a general population of men with ED.
For both Potent I and Potent II studies, vardenafil orodispersible therapy was superior to placebo for all primary and secondary efficacy measures.
Bayer said that the introduction of Levitra in Europe is expected to be initiated in November 2010, while in US it has received approval in June 2010 and is expected to be marketed as Staxyn by GlaxoSmithKline and Merck.
(Source: http://regulatoryaffairs.pharmaceutical-business-review.com)
Levitra 10mg orodispersible tablet is expected to allow men a discreet and convenient intake without water, dissolving on the tongue within seconds with a minty flavour.
Levitra 10mg orodispersible tablet has received approval based on the results from Phase III multinational trials Potent I and II which compared the efficacy and safety of 10mg vardenafil orodispersible tablet with placebo after 12 weeks of treatment in a general population of men with ED.
For both Potent I and Potent II studies, vardenafil orodispersible therapy was superior to placebo for all primary and secondary efficacy measures.
Bayer said that the introduction of Levitra in Europe is expected to be initiated in November 2010, while in US it has received approval in June 2010 and is expected to be marketed as Staxyn by GlaxoSmithKline and Merck.
(Source: http://regulatoryaffairs.pharmaceutical-business-review.com)
Subscribe to:
Posts (Atom)