USFDA inspected Goa facility, no observations issued: Indoco Remedies Farhat Nasim30 March 2019 11:52 AM ISTThe US Food and Drug Administration (USFDA) has cleared the Goa-based sterile manufacturing facility of Indoco Remedies for finished dosages.New...
Manufacturers of SGLT2 inhibitor Drugs to have to INCLUDE safety WARNING in package: CDSCO Farhat Nasim26 March 2019 1:28 PM ISTNew Delhi: Paying heed to the safety updates of Sodium-Glucose Cotransporter-2 (SGLT2) including medicines such as Canagliflozin, Dapagliflozin,...
Alkem Labs gets 8 USFDA observations for St Louis facility Farhat Nasim24 March 2019 9:50 AM ISTThe United States Food and Drug Administration (USFDA) had issued eight observations after inspecting the company's manufacturing plant at St Louis...
Setback: USFDA rejects Sanofi, Lexicon Sotagliflozin for type 1 diabetes Farhat Nasim24 March 2019 9:45 AM ISTThe decision comes about two months after an FDA advisory panel failed to reach a consensus over whether the once-daily oral drug, sotagliflozin,...
Lupin launches generic Levothyroxine Sodium tablets Farhat Nasim22 March 2019 11:30 AM ISTLupin's Levothyroxine Sodium tablet is the generic version of AbbVie Inc's Synthroid tablets, it added. New Delhi: Drug firm Lupin Friday said it has...
USFDA puts partial hold on Abbvie Venclexta clinical trials after deaths Farhat Nasim21 March 2019 9:45 AM ISTThe clinical hold does not impact any of the approved indications for Venclexta, such as chronic lymphocytic leukaemia (CLL) or acute myeloid...
Lupin Somerset facility gets OAI letter from USFDA Farhat Nasim18 March 2019 9:25 AM IST"The USFDA has stated that this facility may be subject to regulatory or administrative action and that it may withhold approval of any pending...
USFDA Caution: Lupin gets OAI letter for MP plant Medical Dialogues Bureau17 March 2019 9:45 AM ISTLupin has received a letter from the US Food and Drug Administration (USFDA) classifying the inspection conducted at its Mandideep (Unit 1) facility...
Glenmark gets USFDA nod for generic version of acne treatment gel Farhat Nasim17 March 2019 9:21 AM ISTNew Delhi: Glenmark Pharmaceuticals Friday said it has received final approval from the US health regulator for its generic version of BenzaClin gel...
Unichem Labs gets USFDA nod to market Allopurinol tablets Farhat Nasim15 March 2019 9:35 AM ISTAllopurinol tablets will be commercialised from company's Ghaziabad plant, Unichem Laboratories said.New Delhi: Drug firm Unichem Laboratories...
Valsartan Shortage: Alkem Labs gets USFDA nod to generic Diovan Farhat Nasim13 March 2019 1:49 PM ISTValsartan, sold under the trade name Diovan among others, is a medication used to treat high blood pressure, heart failure, and diabetic kidney...
Laurus Labs gets USFDA nod to Hydroxychloroquine tablets for treating malaria Farhat Nasim12 March 2019 12:01 PM ISTHydroxychloroquine tablet is also used, usually with other medications, to treat certain auto-immune diseases (lupus, rheumatoid arthritis) when other...
