Page 3 - Us Fda

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

Senators blast health, police officials over illegal sales of e-cigarettes

Senators on Wednesday blasted top health and law enforcement officials for not doing more to combat the rise of illegal electronic cigarettes in the U.S., a multibillion-dollar business that has flourished amid haphazard enforcement. Democrats and Republicans on the Senate Judiciary Committee expressed frustration and exasperation while questioning officials from the Food and Drug Administration and Justice Department about attempts to stay on top of the vaping industry, which has grown to include thousands of flavored, unauthorized e-cigarettes originating in China. Those products, including brands like Elf Bar, have become the most popular choice among American teens who vape. I simply do not understand how FDA and DOJ have permitted thousands of products to remain on store shelves when their manufacturers have not received authorization, or, in some cases, even filed an application, said the committee's chairman, Dick Durbin. The Illinois Democrat displayed a photo of a shelf ..

US FDA grants accelerated approval to Genfit, Ipsen's liver disease drug

Ipsen added that standard approval for Iqirvo may be contingent on confirmatory trials

Cipla rallies 4% on US FDA approval to market Lanreotide injection

The approval for the generic version of Lanreotide Acetate is in line with Cipla's growth strategy in the complex product segment and will strengthen Cipla's position in the US market.

Biocon Biologics announces getting US FDA approval for eye treatment drug

Company says approval is a 'significant milestone' and marks entry in new therapeutic area in the US

US FDA approves expanded use of Bristol Myers' cancer cell therapy

The Food and Drug Administration's decision marks the fourth approval for Breyanzi, which can now be used to treat patients who have received two or more prior lines of therapy

In 6 months, US rejected nearly one-third of MDH's spice-related shipments

Refusal rate over salmonella contamination doubles. When ingested, salmonella can lead to a severe stomach infection affecting the intestinal tract if food is not adequately cooked

US FDA gathering information on Indian spices after alleged contamination

MDH and Everest spices, which are among the most popular names in India and are also sold in Europe, Asia and North America, are also under the Indian regulator's scanner

Zydus Lifesciences unit gets 10 observations from USFDA after inspection

Zydus Lifesciences on Wednesday said the US health regulator has issued ten observations after inspecting its injectable manufacturing plant near Vadodara in Gujarat. The US Food and Drug Administration (USFDA) inspected the facility at Jarod near Vadodara from April 15 to April 23, the drug maker said in a regulatory filing. The inspection closed with ten observations, it added. The company will closely work with the USFDA to address and respond to the observations in an expeditious manner, Zydus Lifesciences said. Shares of the company were trading 2.79 per cent down at Rs 932.80 apiece on the BSE.

Lupin rises over 3% after US FDA approves Mirabegron tablets

The surge came after the United States Food and Drug Administration (US FDA) on April 20, approved the launch of Lupin's Mirabegron extended-release (ER) tablets, 25 mg, in the United States

Sun Pharma recalls 55,000 bottles of generic drug to treat gout from US mkt

Drug major Sun Pharma is recalling around 55,000 bottles of a generic medication to treat gout from the American market due to manufacturing practices norms deviations, according to the US health regulator. The New Jersey-based unit of the Mumbai-based drug major is recalling Febuxostat Tablets in 40 mg and 80 mg strengths, US Food and Drug Administration (USFDA) said in its latest Enforcement Report. Sun Pharmaceutical Industries Inc is recalling 47,520 bottles (40mg) and 7,488 bottles (80 mg) respectively of the medication due to Current Good Manufacturing Practice regulations (CGMP) deviations, it stated. "Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment," the USFDA stated. The affected lot was produced at Sun Pharma's Dadra-based plant for Memphis-based Northstar Rx LLC, the US regulator noted. Febuxostat is used to lower uric acid levels in people with gout. As per the USFDA, the company has initiated the Class II nationwide (