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Groups Sue FDA Over Livestock-Feed Additive
2014-11-10 23:06:00| National Hog Farmer
Source: Wall Street Journal Groups Seeking to Vacate FDAs Approval of Additive Used to Add Weight to Livestock The U.S. Food and Drug Administration has been sued by a coalition of advocacy groups, seeking to vacate its approvals of several livestock-feed products that are widely used to add weight to farm livestock. read more
FDA Approves Cyramza plus Paclitaxel for Advanced Stomach Cancer
2014-11-10 04:18:39| Biotech - Topix.net
Eli Lilly and Company announced recently that the US Food and Drug Administration approved Cyramza in combination with the chemotherapeutic drug paclitaxel as a treatment for people with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose cancer has progressed on or after prior fluoropyrimidine- or platinum-containing chemotherapy. This grants Cyramza two FDA approvals, following on the April approval of Cyramza as a single agent for the same condition.
Tags: advanced
cancer
stomach
fda
UPDATE 1-Dr Reddy's gets FDA approval for Roche drug generic; shares at record high
2014-11-07 15:21:55| Biotech - Topix.net
Indian drugmaker Dr Reddy's Laboratories Ltd said on Friday it has received final approval from the U.S. Food and Drug Administration to make a cheaper version of Roche Holding AG's antiviral Valcyte, sending its stock to a record high. The move comes after Ranbaxy Laboratories Ltd said on Thursday that FDA had stripped the company of its tentative approval to launch the first copy of the drug due to quality control issues at its manufacturing plants.
FDA to Food Facilities: Renew Your Facility Registration Now
2014-10-30 15:43:00| Food Processing
A fairly new requirement of the 2011 FSMA requires food facility registrations by this Dec. 31.
Tags: food
registration
facilities
facility
Lannett Receives FDA Approval for Letrozole Tablets USP 2.5 mg
2014-10-30 13:22:43| Biotech - Topix.net
Lannett Company, Inc. today announced that it has received approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application for Letrozole Tablets USP, 2.5 mg, the therapeutic equivalent to the reference listed drug, FemaraA Tablets, 2.5 mg, of Novartis Pharmaceuticals Corporation. According to IMS, for the year ended September 2014 total sales of Letrozole Tablets USP, 2.5 mg, at Average Wholesale Price were approximately $359 million.
Tags: approval
mg
receives
tablets
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