Latest Articles in usfda
Zydus Gets EIR For Ahmedabad Injectables Manufacturing Facility
The inspection was conducted by the top US regulatory authority from 5th to 13th June 2023, the inspection was a cGMP inspection and had ended with NIL observations
Read More
Glenmark Pulls Back 1,200 Bottles Of Hypertension Drug From US
As per the US Food and Drug Administration (USFDA), Glenmark Pharmaceuticals is in the process of recalling 1,200 bottles of a generic drug which is used in the treatment of high blood pressure, in the US market due to a manufacturing fault
Read More
Gland Pharma Gets 2 Observations On Form 483 In A Pre-market Inspection By USFDA
Gland Pharma informed that the USFDA inspected the Pashamylaram Facility at Hyderabad from 23 August 2023 to 26 August 2023
Read More
Ipca Labs Piparia Facility Receives VAI Status From FDA
Ipca Laboratories on Thursday informed the exchanges that its Piparia (Silvassa) formulations manufacturing facility has received the status "Voluntary Action Indicated (VAI)" from USFDA after the regulator had conducted an inspection on the unit from 18th April 2023 to 26th April 2023.
Read More
Lupin Pharmaceuticals Recalls Pregnancy Prevention Drug In US
Lupin Pharmaceuticals Inc., a wholly-owned subsidiary of Lupin is voluntarily recalling two lots of Tydemy to the patient level due to out-of-specification (OOS) test results at the 12-month stability time point
Read More
Granules India Gets USFDA Nod For OTC Equivalent Of Advil Dual Action Tablets
Acetaminophen and Ibuprofen Tablets are used for temporary relief for minor aches and pains due to: headaches, toothache, backache, menstrual cramps, muscular aches, minor pain of arthritis
Read More
Marksans Pharma Gets USFDA Nod For OTC Equivalent Of Advil
Marksans Pharma on Wednesday said that it has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg, over-the-counter (OTC) bioequivalent of Advil Dual Action Tablets 250 mg/125 mg
Read More
USFDA Panel Disapproves Intercept Fatty Liver Drug For Safety Issues
The panel of outside experts voted 15-to-1 against the approval for obeticholic acid (OCA) based on surrogate biomarker data suggesting it was likely to benefit patients with NASH (non-alcoholic steatohepatitis) and fibrosis, or scarring, of the liver.
Read More
FDA Denies Marketing Approval For 6,500 Flavored E-cigarettes
The U.S. Food and Drug Administration (FDA) on Friday issued marketing denial orders to 10 companies which collectively manufacture and market about 6,500 flavored e-liquid and e-cigarette products
Read More
USFDA Eases Guidelines On Blood Donation
The US Food and Drug Administration on Thursday set guidelines for blood donation organisations, recommending they screen donors based on one set of criteria, ending a restrictive policy that applied only to men who have sex with men and their female partners
Read More