Search Result for : Natco Pharma

Natco Pharma gets ANDA nod for Tamiflu drugs

PTI Natco Pharma Ltd today said it has received final approval for its Abbreviated New Drug Application (ANDA) for generic versions of Tamiflu oral capsules (Oseltamivir Phosphate), 30 mg, 45 mg and 75 mg, from the US Food and Drug Administration. “Natco and its marketing partner Alvogen are the first generic players to receive this approval,” Natco said in a regulatory filing. Tamiflu is used to treat the flu (influenza) in people 2 weeks of age and older who have had flu symptoms for no more than two days. Tamiflu can also reduce the chance of getting the flu in people one year and older. Earlier in December, 2015, Natco and Alvogen settled a patent infringement with Gilead Sciences, Inc., Hoffmann-La Roche Inc., F. ...

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 ...