Page 3 - Us Fda

Lupin gets clearance from USFDA for its Pithampur manufacturing facility

Lupin, headquartered in Mumbai, India, is a global pharmaceutical player with products distributed in over 100 markets

FDA proposes new testing guidelines to ensure asbestos-free cosmetics

Cosmetic companies would have to take extra steps to ensure that any products containing talc are free of asbestos under a new proposed federal rule. The proposal from the Food and Drug Administration on Thursday and mandated by Congress is intended to reassure consumers about the safety of makeup, baby powder and other personal care products. It follows years of lawsuits against Johnson & Johnson and other companies alleging links between talc-based baby powder and cancer. Despite the lawsuits, research has found mixed evidence of a potential link between cancer and talc, although the possibility has been recognised for decades because of how it is mined. Talc is a mineral used to absorb moisture or improve the texture, feel and colour of cosmetics. It is mined from underground deposits that are sometimes located near the toxic mineral asbestos. The risk of cross contamination has long been recognised by cosmetic companies. But recent FDA-sponsored testing hasn't uncovered any ..

Eli Lilly's weight-loss, diabetes drug shortage is resolved, says US FDA

The finding effectively bars widespread sales of cheaper copies of the drugs that many patients use, but the FDA said it would not take any action against the compounding pharmacies

Granules India share tanks 10% after USFDA's 'OAI' tag for Gagillapur Unit

The fall in Granules India share price came after the company announced that United States Food and Drug Administration (USFDA) has classified the inspection of Gagillapur unit as OAI

Marty Makary seen as leading candidate for Donald Trump's FDA pick

Makary, a pancreatic surgeon at Johns Hopkins Medicine, is a health researcher whose latest book focuses on questioning medical orthodoxy on topics from peanut allergies to antibiotics

Dozens fall sick, 1 dead after eating carrots contaminated with E coli

An outbreak of E coli has infected dozens of people who ate bagged organic carrots, and one person died from the infection. Altogether, 39 people were infected and 15 hospitalised in 18 states after eating organic whole and baby carrots sold by Grimmway Farms, the federal Centers for Disease Control and Prevention said on Sunday. Grimmway Farms, based in Bakersfiled, California, has recalled the carrots, which included whole and baby organic carrots sold in bags under multiple brand names. The carrots are no longer in stores but the CDC is warning consumers to not eat recalled bag carrots and to check their refrigerators or freezers and throw away any carrots that fit the description. Most of the infected people live in New York, Minnesota and Washington, followed by California and Oregon, although infections have been reported in states throughout the country, according to the CDC. There have been several E coli outbreaks in recent months. In October, more than 100 McDonald's ...

Dr Reddy's, FDC recall generic medications in US over manufacturing issues

Dr Reddy's Laboratories and FDC Ltd are recalling generic medications in the US market due to manufacturing issues, according to the US health regulator. As per the latest Enforcement Report by Food and Drug Administration (USFDA), the US-based subsidiary of Dr Reddy's Laboratories is recalling multiple strengths of Morphine Sulfate extended-release tablets in the US. The medication is used to relieve severe and persistent pain. As per the USFDA, Princeton-based Dr Reddy's Laboratories Inc is recalling 2,040 bottles of 15 mg Morphine Sulfate extended-release tablets due to "Failed Impurities/Degradation Specification". The drugmaker is also recalling another 532 100-count bottles of the medication in 30 mg strength for the same reason, USFDA stated. Dr Reddy's initiated the Class II nationwide recall on October 22 this year. USFDA said Mumbai-headquartred FDC Ltd is recalling 1,55,232 bottles of Timolol Maleate ophthalmic solution in the US market. The company is recalling the .

Glenmark arm recalls two products in US due to manufacturing issues

Drug firm Glenmark is recalling two products in the US due to manufacturing issues, according to the US Food and Drug Administration. New Jersey-based Glenmark Pharmaceuticals Inc, USA, a unit of Mumbai-based Glenmark Pharmaceuticals, is recalling 45,504 bottles of Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray. The company is recalling the affected lot due to "defective delivery system", the US Food and Drug Administration (USFDA) said in its latest enforcement report. "The dip tube is clogged causing the spray not to work," it added. Glenmark Pharmaceuticals Inc, USA, initiated the nationwide (US) Class II recall on September 24 this year. As per the USFDA, a Class II recall is initiated in a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. The US health regulator said the drug firm is also ...

US FDA grants fast track status to Wockhardt's novel antibiotic WCK 6777

WCK 6777 is a once-a-day, β-lactam enhancer used for outpatient parenteral antimicrobial therapy

US FDA approves Bristol Myers' Squibb drug for treating schizophrenia

Bristol Myers obtained the drug Cobenfy, also known as KarXT, through its $14 billion takeover of Karuna Therapeutics last year

USFDA cites manufacturing lapses at Zydus Lifesciences' Gujarat plant

The US health regulator has pulled up Zydus Lifesciences for manufacturing lapses at its Gujarat-based plant. In a warning letter to company's Managing Director Sharvil Patel, the US Food and Drug Administration (USFDA) noted that the drug maker failed to investigate contamination identified in drug products at its Jarod-based plant in Vadodara district. The USFDA said it inspected the manufacturing facility from April 15 to 23, 2024. "This warning letter summarises significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals," it added. It further said: "Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated." A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations. Elaborating on the manufacturing issues at the facility, USFDA noted: "Your firm failed to thorough

USFDA approves injectable version of Roche's multiple sclerosis therapy

The therapy is already approved as an infusion or IV therapy for multiple sclerosis, which is given twice a year, under the brand name Ocrevus

US FDA expands J&J's psoriasis drug Tremfya for inflammatory bowel disease

Drugmakers such as AbbVie, Eli Lilly and J&J are hustling for a share in an already-crowded, multi-billion market for treatments for inflammatory bowel diseases

USFDA still struggling to conduct pending drug inspections after Covid

Federal regulators responsible for the safety of the US drug supply are still struggling to get back to where they were in 2019, before the COVID-19 pandemic upended factory inspections in the US and across the world, The Associated Press has found. An AP analysis of Food and Drug Administration data shows that agency staffers have not returned to roughly 2,000 pharmaceutical manufacturing firms to conduct surveillance inspections since before the pandemic. The firms that are overdue for safety and quality inspections represent about 42 per cent of the 4,700 plants that are currently registered to produce drugs for the US and previously underwent FDA review before May 2019, the AP found. Most of the overdue plants are in the US, but more than 340 are in India and China, countries that together make up the largest source of drug ingredients used in low-cost US prescriptions. Generic drugmakers are under intense pressure to cut their costs and some will do that by cutting quality, sa

US FDA declines to approve Regeneron's therapy for common blood cancer

FDA, in a so-called 'complete response letter', said that the sole issue identified for approval is related to findings from a pre-approval inspection at a third-party manufacturer

Aurobindo Pharma arm gets warning letter from USFDA for Telangana unit

Aurobindo Pharma Ltd on Friday said its arm Eugia Pharma Specialities Ltd received a warning letter from the US health regulator for its formulations manufacturing unit in Telangana. Earlier in May, the company had stated that Unit-III, a formulation manufacturing facility of Eugia Pharma Specialities Ltd., a wholly-owned subsidiary, received Official Action Indicated (OAI) status by the US Food and Drug Administration (USFDA). "Subsequent to OAI, the unit has received a warning letter," Aurobindo Pharma said in a regulatory filing. It did not elaborate on the details of the warning by the regulator. "There is no impact on the existing supplies to the US markets," the company said. Aurobindo Pharma said it remains committed to work closely with the USFDA and continues to enhance its compliance on an ongoing basis. The USFDA had conducted an inspection at Unit-III, a formulation manufacturing facility of Eugia Pharma Specialities Ltd, located at Pashamylaram, Patancheru Mandal, ..

US FDA approves first nasal spray from ARS Pharmaceuticals' for allergies

Neffy's approval is based on 4 studies in 175 healthy adults without anaphylaxis that measured epinephrine concentrations in blood following administration of neffy

US FDA approves first nasal spray from ARS Pharmaceuticals' for allergies

Neffy's approval is based on 4 studies in 175 healthy adults without anaphylaxis that measured epinephrine concentrations in blood following administration of neffy

USFDA approves second Alzheimer's drug that can modestly slow disease

U.S. officials have approved another Alzheimer's drug that can modestly slow the disease, providing a new option for patients in the early stages of the incurable, memory-destroying ailment. The Food and Drug Administration approved Eli Lilly's Kisunla on Tuesday for mild or early cases of dementia caused by Alzheimer's. It's only the second drug that's been convincingly shown to delay cognitive decline in patients, following last year's approval of a similar drug from Japanese drugmaker Eisai. The delay seen with both drugs amounts to a matter of months about seven months, in the case of Lilly's drug. Patients and their families will have to weigh that benefit against the downsides, including regular IV infusions and potentially dangerous side effects like brain swelling. Physicians who treat Alzheimer's say the approval is an important step after decades of failed experimental treatments. I'm thrilled to have different options to help my patients, said Dr. Suzanne Schindler, a .

Torrent Pharma slips 3% after USFDA issues 5 observations for Indrad Unit

The fall came after the United States Food and Drug Administration (USFDA) issued a Form 483 with five observations for the Indrad unit