Aurobindo Pharma USA recalls heartburn drug Ranitidine over cancer causing impurities Medical Dialogues Bureau10 Nov 2019 9:45 AM ISTAurobindo Pharma is second city-based drug company that has initiated the voluntary recall after the FDA announced an investigation into the reported...
Shilpa Medicare gets USFDA approval for generic equivalent of cancer drug TARCEVA Farhat Nasim8 Nov 2019 10:00 AM ISTErlotinib Tablets, 25 mg, 100 mg, and 150 mg is a generic equivalent of reference listed drug (RLD) TARCEVA used in the treatment of patients with...
Penalty levied by SEBI on Jubilant Life Sciences reduced to Rs 5 lakh Medical Dialogues Bureau8 Nov 2019 9:30 AM IST"We have found that the appellant in... Jubilant Life Sciences would be liable for a penalty only on one count i.e. for non-disclosure of the China...
New USFDA warning letters show Glenmark, Lupin, Cadila Healthcare in trouble Medical Dialogues Bureau7 Nov 2019 4:20 PM ISTCadila Healthcare Ltd., Glenmark Pharmaceuticals Ltd. and Lupin Ltd. are the latest local medicine makers to be reprimanded by the US Food and Drug...
Novartis gets U.S. nod for long-delayed copycat version of Amgen billion seller Neulasta drug Medical Dialogues Bureau6 Nov 2019 10:32 AM ISTZURICH: Novartis on Tuesday won U.S. approval for its long-delayed version of Amgen's $4 billion seller Neulasta drug, helping the Swiss drugmaker in...
Biocon gets EIR from USFDA for Bengaluru biologics unit Medical Dialogues Bureau6 Nov 2019 9:19 AM ISTNew Delhi: Biopharmaceutical firm Biocon on Tuesday said it has received an establishment inspection report (EIR) from the US health regulator for its...
Zydus Cadila receives warning letter from USFDA for Moraiya-based formulation facility Medical Dialogues Bureau5 Nov 2019 12:57 PM ISTNew Delhi: Drug firm Zydus Cadila on Monday said it has received a warning letter from the US health regulator for its Moraiya-based formulation...
Strides Pharma Ranitidine tablets within acceptable NDMA limits, says USFDA Medical Dialogues Bureau4 Nov 2019 4:31 PM ISTNew Delhi: Drug firm, Strides Pharma recently announced that the USFDA issued a statement1 on November 1, 2019, providing an update with the latest...
Indoco Remedies gets USFDA ANDA nod for Glycopyrrolate Injection Medical Dialogues Bureau3 Nov 2019 10:00 AM ISTGlycopyrrolate is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the...
Stempeutics gets patent for stem cell drug Stempeucel from US Patent and Trademarks Office Medical Dialogues Bureau3 Nov 2019 9:55 AM IST"The US patent is for the method of treating ischemia by administering pooled allogeneic mesenchymal stromal cells," Stempeutics Research said in a...
Another delay in USD 2.1 million gene therapy Zolgensma data reporting, Novartis admits mistake Medical Dialogues Bureau3 Nov 2019 9:45 AM ISTThe USFDA on Wednesday placed a partial hold on a Novartis trial of the $2.1 million-per-patient gene therapy, Zolgensma after the company informed...
Lupin gets USFDA nod for generic version of Levoxyl tablets to treat hypothyroidism Medical Dialogues Bureau2 Nov 2019 10:00 AM ISTThe product is a generic version of King Pharmaceuticals Research and Development LLC's Levoxyl tablets in same strengths, Lupin said.New Delhi: Drug...
