FDA Accepts Psyadon IND In LND Trial

Psyadon Pharmaceuticals has announced that the FDA has accepted its Investigational New Drug Application (IND) to study ecopipam in patients with lesch-nyhan disease (LND). ...

Published: 09-Feb-2010

FDA Postpones Review Meeting For Pixantrone

FDA has informed Cell Therapeutics (CTI) that due to severe weather conditions in the Washington, DC area, it is postponing the Oncologic Drugs Advisory Committee (ODAC) meeting that was to be held on...

Published: 09-Feb-2010

Sagent Receives FDA Approval For Labetalol Hydrochloride Injection, USP

Sagent Pharmaceuticals (Sagent) has received FDA approval for lbetalol hydrochloride (HCl) injection, USP, commonly used to control severe hypertension. The product will be available in two multi-dose...

Published: 08-Feb-2010

Lupin Receives FDA Approval For Amlodipine/Benazepril Capsules

Lupin has received final approval for Amlodipine/ Benazepril 2.5mg/10mg, 5mg/10mg, 5mg/20mg and 10mg/20mg capsules. Commercial shipment of the product has already initiated. ...

Published: 08-Feb-2010

Lipoxen Gets European Patent For Polysialylated G-CSF StimuXen Technology

Lipoxen, a bio-pharmaceutical company with expertise in differentiated biologicals, vaccines and siRNA delivery, has got patent for Polysialylated G-CSF StimuXen technology in UK, Germany, France, Spa...

Published: 08-Feb-2010

European Commission Approves Almirall's BPH Drug

Almirall has reported that the European Commission has granted a marketing authorisation for Silodosin. The product will be marketed in Spain by Almirall and Recordati under the trademarks, Silodyx an...

Published: 08-Feb-2010

Daiichi Sankyo Subsidiary Submits NDA For SUN Y7017 In Japan

Daiichi Sankyo has announced that its subsidiary, Asubio Pharma, has submitted a New Drug Application in Japan for the manufacturing and marketing of SUN Y7017 (generic name: Memantine hydrocholoride)...

Published: 08-Feb-2010

Repros Responds To FDA On Androxal

Repros Therapeutics (Repros) has responded to the FDA as requested by the agency during the Type C meeting held on January 25, 2010. The company has sent a revised indication statement to the FDA’s Di...

Published: 08-Feb-2010

FDA Issues Complete Response Letter To IntelGenx' CPI-300

FDA has issued Complete Response Letter to IntelGenx for it's New Drug Application (NDA) of the antidepressant CPI-300, which the company developed with Cary Pharmaceuticals (Cary Pharma). ...

Published: 08-Feb-2010

Lux Biosciences Files For US, European Approval Of Voclosporin

Isotechnika Pharma has reported that its partner, Lux Biosciences has filed a New Drug Application (NDA) with the FDA and a Market Authorization Application (MAA) with the European Medicines Agency (E...

Published: 05-Feb-2010

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