Novartis sickle cell drug crizanlizumab secures speedy USFDA review Medical Dialogues Bureau17 July 2019 9:26 AM ISTNovartis submitted the application for crizanlizumab for the prevention of vaso-occlusive crises (VOCs) in patients with sickle cell disease (SCD) and...
USFDA issues warning letter to Indoco Remedies for Goa plant Medical Dialogues Bureau16 July 2019 11:39 AM ISTThe facility had received six observations in Form 483s and was classified as Official Action Indicated in March. Indoco Remedies responded to these...
Natco Pharma gets zero USFDA observations for Chennai facility Medical Dialogues Bureau16 July 2019 9:30 AM ISTNatco Pharma announced "successful completion of regulatory inspection from the US Food and Drug Administration (USFDA) for its active pharmaceutical...
Lupin to focus on launch of biosimilar, inhalation product in US this fiscal Medical Dialogues Bureau15 July 2019 9:45 AM ISTCoupling this with the building of Solosec brand in the US, NaMuscla in Europe and Bipresso in Japan will help Lupin drive sustainable growth, they...
Lupin unveils generic Imatinib Mesylate tablets to treat types of cancer Medical Dialogues Bureau10 July 2019 10:00 AM ISTLupin's Imatinib Mesylate Tablets, 100mg (base) and 400mg (base), is the generic version of Novartis Pharmaceuticals Corporation's (Novartis) Gleevec...
Sun Pharma Research Arm- SPARC gets USFDA orphan drug designation for novel kinase inhibitor Medical Dialogues Bureau9 July 2019 12:49 PM ISTMumbai: Sun Pharma Advanced Research Company (SPARC) on Monday said the US health regulator has given orphan drug designation to its novel kinase...
Dr Reddys plans to launch value-added drugs in US as part of diversification, market entry strategy Medical Dialogues Bureau8 July 2019 1:32 PM ISTAs part of the diversification and new market entry strategy, DRL (Dr Reddys) plans to re-focus some of its Research and Development resources to...
Zydus Cadila gets USFDA nod for generic Misoprostol tablets to treat ulcers Medical Dialogues Bureau5 July 2019 11:52 AM ISTNew Delhi: Drug firm Zydus Cadila Wednesday said it has received the final nod from the US health regulator to market its generic Misoprostol tablets...
Elizabeth Warren asks former USFDA chief Gottlieb to QUIT Pfizer board Medical Dialogues Bureau5 July 2019 9:10 AM ISTIn a letter to Gottlieb, Warren, who is seeking the Democratic nomination for the 2020 presidential election, said "this kind of revolving door...
Lupin gets USFDA nod for generic versions of Sensipar tablets, Omidria intraocular solution Medical Dialogues Bureau4 July 2019 9:45 AM ISTCinacalcet tablets are a generic version of Amgen Inc's Sensipar tablets in the same strengths, said Lupin.New Delhi: Drug firm Lupin on Wednesday...
Alembic Pharma gets USFDA nod for generic version of Uloric tablets Farhat Nasim2 July 2019 11:49 AM ISTThe approved product, Febuxostat tablet is therapeutically equivalent to the reference listed drug Uloric tablets of Takeda Pharmaceuticals USA, Inc....
Alembic Pharma gets USFDA nod for Clonazepam orally disintegrating tablets Farhat Nasim1 July 2019 12:25 PM ISTThe approval from the United States Food and Drug Administration (USFDA) is for the company's abbreviated new drug application (ANDA) for Clonazepam...
