USFDA returns Mylan-Biocon’s drug application for more data

The U.S. Food and Drug Administration has sought more data before approving a chemotherapy compound submitted by Mylan and jointly developed by Biocon. The agency issued a ‘complete response letter’. Such letters are issued when an FDA review an FDA review finds that an application for a new drug cannot be approved ‘in its present […]

Lupin launches generic antidepressant in the US

India’s second biggest pharmaceutical company Lupin said it has launched the generic version of Valeant’s Wellbutrin antidepressant tablet Wellbutrin XL in the US. Wellbutrin XL tablet has yearly US sales of USD 758 million or about Rs 5,000 cr. It is used for the treatment of major depressive disorder (MDD) and prevention of seasonal affective […]

Suven Life Sciences gets US, Australia patent for CNS molecule

Suven Life Sciences Ltd said it got a patent from Australia and another from the US for a new molecule used for treating disorders associated with Neurodegenerative diseases. The ‘new chemical entity’ patent no 2014358652 from Australia is valid through 2032, while that from the US will last till 2034, the company said. The chemical […]

Smuggling down on Indo-Bangladesh border, up on Bhutanese side

Incidents related to smuggling of fertilizer and narcotics on the Indo-Bangladesh border fell sharply in 2016, but there was a compensatory increase in drug smuggling cases along India’s border with Bhutan and Nepal, according to data from the Union Home Ministry. Fertilizers — which cost less in India because of government subsidies — are smuggled out, […]

Lopinavir syrup for children with HIV now available across India – Govt

Minister of health and family welfare Anupriya Patel said Lopinavir syrup, the life-saving drug given to infants and toddlers with HIV has been restocked by the National Aids Control Organization. “NACO has done an emergency procurement from a registered manufacturer — McNeil and Argus. The drug has already been supplied and is available throughout the […]

Mylan and Biocon submits breast cancer drug application to USFDA

Mylan N.V. and Biocon Ltd. said they submitted Mylan’s biologics license application for a proposed biosimilar Trastuzumab, to the U.S. Food and Drug Administration. Biosimilar trastuzumab is a proposed biosimilar to branded Trastuzumab, which is indicated to treat certain HER2-positive breast and gastric cancers. HER2-positive breast cancer is a breast cancer that tests positive for […]