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, ...
Natco gets tentative nod to sell Sorafenib in US
The Dollar Business Bureau Indian drug manufacturer Natco Pharma Ltd said on Friday that its marketing associate Mylan Inc has got tentative approval from the USFDA for marketing generic drug Sorafenib that is used in the treatment of cancer in the US market. “Mylan Inc has got a tentative nod from the USFDA (United States Food and Drug Administration) for its Abbreviated New Drug Application (ANDA) for 200 mg Sorafenib tablets,” Natco Pharma said in a statement. "Natco and Mylan have submitted an application comprising a Paragraph IV certification for Sorafenib tablets," it added. This product has been manufactured by Natco at its Kothur facility in the state of Telangana, the company said. Sorafenib tablets in the strength of 200mg were sold by Onyx ...
Govt approves Mylans FDI proposal worth $750 million
The Dollar Business Bureau The government on Thursday approved the FDI proposal of Mylan’s Luxembourg and the Netherlands units to invest up to $750 million in its Bangalore-based Mylan Laboratories Ltd. (MLL) through subscription of equity shares. “With this approval, FDI of $750 million will be received in the country. The production level of consumables and NLEM drugs and their supply to the domestic market at the time of induction of FDI, be maintained over the next five years at an absolute quantitative level,” Ministry of Finance said in a statement. The union cabinet chaired by the Prime Minister Narendra Modi, however, laid out some conditions and directed MLL to be transparent in terms of its operations, especially in transfer of technology ...
