HC allows Biocon, Mylan to sell their drug for three cancers
PTI The Delhi High Court today allowed drug companies Biocon and Mylan to sell their version of Trastuzumab for two kinds of breast cancer and metastatic gastric cancer in view of the approval granted to it by the Drugs Controller General of India (DCGI). "In view of the fact that appropriate authority has approved the package insert and the drug for all three indications (diseases), we feel there should be no restriction imposed at this stage with regard to second and third indication also," a bench of justices Badar Durrez Ahmed and Sanjeev Sachdeva said. "Consequently, till further orders, Biocon and Mylan are permitted to sell Trastuzumab under their respective brand names for all three indications (metastatic breast cancer, ...
Indian drug maker gets USFDA nod to market pain relievers
The Dollar Business Bureau Indian drug major Aurobindo Pharma, on Friday, got an approval from the United States Food and Drug Administration (USFDA) to manufacture and market drugs used in the long-term treatment of moderate-to-severe pain in adults. “The company has received final approval from the USFDA to manufacture and market Tramadol Hydrochloride Extended-release Tablets USP, 100 mg, 200 mg and 300 mg (ANDA 204421). This product will be launched by Q4 FY 2015-16,” said an official release. The approved product, having an estimated market size of $56 million for the twelve months ending August (according to IMS), is the 50th Abbreviated New Drug Application (ANDA-US generic drug approval for an existing licensed medication) to be approved at ‘formulation facility for ...
