Amid cancer scare GSK recalls heartburn drug Zantac as precautionary measure Medical Dialogues Bureau9 Oct 2019 9:30 AM ISTGSK is recalling all unexpired stock of Zantac from pharmacies due to possible contamination with an impurity N-nitrosodimethylamine (NDMA), the...
Aurobindo Pharma Unit-7 gets 7 USFDA observations Medical Dialogues Bureau8 Oct 2019 2:54 PM ISTThe United States Food and Drug Administration (USFDA) conducted a Current Good Manufacturing Practices (CGMP) inspection at the company's unit-7...
SPARC neonatal seizures drug Phenobarbital gets Orphan Drug Designation from USFDA Farhat Nasim5 Oct 2019 12:00 PM ISTOrphan Drug Designation will grant seven years of US market exclusivity upon approval of Phenobarbital for the treatment of patients with neonatal...
Alembic JV Aleor Derma gets USFDA nod for therapeutic equivalent of Clobex Spray Farhat Nasim4 Oct 2019 12:40 PM ISTClobetasol Propionate Spray, 0.05% is indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA)...
Natco Pharma Mekaguda facility gets EIR from USFDA Farhat Nasim1 Oct 2019 3:57 PM ISTHyderabad: Drug firm Natco Pharma today said it has received Establishment Inspection Report (EIR) from the US health regulator for its Active...
Cadila Healthcare to sell right of cholesterol-lowering drug Zypitamag for Rs 49 crore Farhat Nasim1 Oct 2019 2:13 PM ISTThe company has entered into an asset purchase agreement to sell its right, title and interest in Zypitamag, along with applicable registrations and...
Cipla gets 12 USFDA observations for Goa facility Medical Dialogues Bureau30 Sept 2019 3:15 PM IST"The United States Food and Drug Administration (USFDA) conducted a cGMP inspection at our Goa manufacturing facility from September 16-27, 2019,"...
Abbott neurostimulation system Proclaim XR gets USFDA nod for chronic pain Medical Dialogues Bureau29 Sept 2019 9:55 AM ISTProclaim XR is currently under review for CE Mark. It is the latest advancement from Abbott, featuring upgradeable software and consumer-friendly...
Strides Pharma gets USFDA nod for generic version of Vesicare Tablets to treat overactive bladder Medical Dialogues Bureau28 Sept 2019 2:38 PM IST"Solifenacin Succinate Tablet is a generic version of Vesicare Tablets, 5 mg and 10 mg, of Astellas Pharma US, Inc, " Strides Pharma said.Bangalore:...
Strides Pharma suspends sale of Ranitidine tab in US Medical Dialogues Bureau27 Sept 2019 9:56 AM ISTNew Delhi: Strides Pharma Science on Friday suspended the sale of Ranitidine tablets after it received an information request from the US health...
Novo Nordisk wins USFDA nod for oral diabetes drug Rybelsus Medical Dialogues Bureau23 Sept 2019 2:16 PM ISTNovo Nordisk did not disclose what it plans to charge for the new oral treatment, called Rybelsus, but said it would be "competitively priced" with...
Biocon gets USFDA Form 483 with 8 observations for 2 new facilities in Bengaluru Medical Dialogues Bureau23 Sept 2019 10:15 AM IST"At the conclusion of the inspection, we received a Form 483 with four observations for the new Drug Substance facility, three observations for the...
