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, ...
Strides Shasun gets DCGI approval to manufacture Hepatitis C drug
The Dollar Business Bureau The drug will be marketed under the brand name ‘Virso’ in India and overseas Bangalore-based Strides Shasun Ltd. on Monday announced that it has received DCGI (Drug Controller General of India) nod for manufacturing generic version of Sofosbuvir 400mg drug. The drug major entered into a licensing agreement with Gilead Sciences – a US-based biopharmaceutical company - to bring Hepatitis C cure to 91 developing countries. The product will be marketed under the brand name ‘Virso’ in India and overseas. “The high potency, high barrier to resistance, pan genotypic activity, one-daily dosage, good safety profile and the limited drug-drug interaction of Sofosbuvir make it a breakthrough drug in Hepatitis C treatment,” Strides Shasun said in a statement. ...
Natco gets DCGI approval to launch hepatitis C drug
The Dollar Business Bureau New Delhi-based Natco Pharma Ltd. on Tuesday announced that it has received approval for the generic version of ledipasvir and sofosbuvir combination from Drugs Controller General India (DCGI). NATCO plans to launch this combination drug under its brand name Hepcinat LP. The medicine will be used for the treatment of chronic Hepatitis C (CHC) genotype 1 infection in adults. The medicine contains 90 mg of ledipasvir and 400 mg of sofosbuvir in a single tablet and is sold globally by Gilead Sciences - a US based biotechnology firm. Ledipasvir and Sofosbuvir is a two-drug fixed-dose combination product that will be sold under the brand name HARVONI. “This single-tablet regimen is the first of its kind to offer ...
