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Top Pharma news of the week
India Infoline News Service | Mumbai | December 03, 2010 17:35 IST
Natco to accept ANDA for genericversion of Oseltamivir Phosphate
NatcoPharma Limited is pleased to announce the acceptance of its Abbreviated NewDrug Application for the generic
version of Oseltamivir Phosphate capsules.Natco has tied up with Luxemburg based Alvogen IPCO S.a.r.l for marketing
andsale of Oseltamivir Phosphate in the USA. Natco is the first applicantto file an ANDA for the generic version of
Tamiflu and should the ANDA beapproved may be entitled to 180 days of generic market exclusivity.
Glenmark announces positiveresults from Crofelemer study
Glenmarkannounces positive results from the multi-centre study of Crofelemer in acutewatery diarrhoea in adult patients.
In this multi-centre, placebo controlledtrial, resolution of diarrhoea was significantly higher in the Crofelemer armcompared to placebo. The clinical success
rate was also greater in theCrofelemer arm compared to placebo. Crofelemer was found to be safe with noapparent differences in adverse event profile in the
Crofelemer group comparedto placebo.
Thistrial in mild to moderate adult patients with acute watery diarrhoea was thesecond proof of concept study conducted by Glenmark with Crofelemer.
Adultpatients with mild to moderate diarrhoea were dosed with Crofelemer over aperiod of 3 days with a follow-up period of 30 days. This was a 3 arm drug
vsplacebo study which included a 125 mg, 250 mg and a 500 mg dose of Crofelemer.Overall Crofelemer showed superiority to the placebo arm. For the
efficacy parameterof stool frequency, there was a significant difference in the reduction ofnumber of stools per day during 3 days of treatment period between
both thelowest and highest Crofelemer doses versus Placebo. ReadMore
AstraZeneca and Taj launchesGemcitabine HCI for Injection: report
AstraZenecaPharmaceuticals and Taj Pharmaceuticals, have commercially launched GemcitabineHCI for Inj