Glenmark gets tentative USFDA nod for Abiraterone Acetate tablets Medical Dialogues Bureau24 Jan 2019 9:30 AM ISTGlenmark Pharmaceuticals Inc USA has been granted tentative approval by the United States Food and Drug Administration for Abiraterone Acetate tablets...
FDA grants priority review for Sanofi's dengue vaccine candidate Medical Dialogues Bureau4 Nov 2018 11:00 AM ISTThe vaccine, known as Dengvaxia in countries where it is approved, remains the only vaccine available for the prevention of dengue. The European...
Hetero Labs recalls over 15.90 lakh bottles of hypertension drug from US Ruby Khatun Khatun30 Aug 2018 11:26 AM ISTNew Delhi: Drug firm Hetero Labs is recalling over 15.90 lakh bottles of Valsartan Tablets used for the treatment of hypertension from the American...
Unichem Labs gets 4 observations from USFDA for Roha facility Ruby Khatun Khatun8 Aug 2018 10:30 AM ISTNew Delhi: Drug firm Unichem Laboratories said the US health regulator has made four observations after inspection of its active pharmaceutical...
Morepen labs gets USFDA approval for 2 bulk drug manufacturing units Ruby Khatun Khatun1 Aug 2018 10:47 AM ISTNew Delhi: Morepen Laboratories Ltd. has received USFDA (United States Food and Drug Administration) approvals for both its bulk drugs manufacturing...
Alkem Labs gets EIR from USFDA for its Daman facility Ruby Khatun Khatun25 July 2018 10:15 AM ISTNew Delhi: Drug firm Alkem Laboratories said the US health regulator has issued an establishment inspection report (EIR) for its Daman...
Zydus Cadila gets USFDA nod for skin ointment, stomach ailment drug Ruby Khatun Khatun28 May 2018 10:30 AM ISTNew Delhi: Zydus Cadila has received final approval from the US health regulator to market Nystatin ointment and Omeprazole and Sodium Bicarbonate...
Lupin gets USFDA nod to market Tetrabenazine tablets Ruby Khatun Khatun24 April 2018 10:15 AM ISTNew Delhi: Drug firm Lupin said it has received approval from the US health regulator to market in America its Tetrabenazine tablets used for the...
Dr Reddy's gets EIR for Hyderabad facility Ruby Khatun Khatun4 Dec 2017 10:45 AM ISTNew Delhi: Drug firm Dr. Reddy's Laboratories today said it has received establishment inspection report (EIR) from the US health regulator for its...
GSK submits US regulatory application for single-dose Tafenoquine for Plasmodium vivax malaria Ruby Khatun Khatun1 Dec 2017 10:02 AM ISTLondon, UK, Geneva, Switzerland: GSK and Medicines for Malaria Venture (MMV) announced the submission of a new drug application (NDA) by GSK to the...
Strides Shasun gets USFDA nod for altitude sickness tablets Ruby Khatun Khatun23 Nov 2017 10:30 AM ISTBangalore: Strides Shasun Limited announced that it's wholly owned subsidiary Strides Pharma Global Pte. Ltd. has received approval from the United...
