Page 4 - Us Fda

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 (

Aurobindo Pharma's new injectable facility get 10 observations from US FDA

"The observations are procedural and will be responded to within the stipulated time," the company stated in a regulatory filing

Zydus Lifesciences gets six observations from USFDA for API plant

Zydus Lifesciences on Friday said the US health regulator has issued six observations after inspecting its active pharmaceutical ingredient (API) site in Ahmedabad, Gujarat. The US Food and Drug Administration (USFDA) conducted the inspection from December 14 to December 22, 2023. The inspection closed with six observations, Zydus Lifesciences said in a regulatory filing. There were no data integrity related observations, it added. Besides, there are no repeat observations from the previous inspection, it noted. There are four drug master files (DMFs) from the site under approval with the USFDA, the drugmaker said. The company will closely work with the USFDA to address the observations, it added.

First gene-editing therapy for sickle cell disease approved by US FDA

The agency approved Lyfgenia from bluebird bio, and a separate treatment called Casgevy by partners Vertex Pharmaceuticals and Crispr Therapeutics

Strides Pharma arm obtains USFDA nod for Levetiracetam oral solution

According to market research firm IQVIA, the Levetiracetam oral solution has a market size of $55 million

First chikungunya vaccine, Ixchiq, approved by US FDA for people above 18

Ixchiq, the first chikungunya vaccine, has been approved by the US Food and Drug Administration (FDA) for individuals 18 years of age and older who are at increased risk of exposure to mosquito-borne virus. Containing a live, weakened version of the chikungunya-causing virus, Ixchiq is administered as a single dose by injection into the muscle and may cause symptoms in the recipient similar to those experienced by people having the viral disease, the FDA said in a statement. "Infection with chikungunya virus can lead to severe disease and prolonged health problems, particularly for older adults and individuals with underlying medical conditions," said Peter Marks, director of the FDA's Center for Biologics Evaluation and Research. "Today's approval addresses an unmet medical need and is an important advancement in the prevention of a potentially debilitating disease with limited treatment options," said Marks. The effectiveness of the vaccine was determined through a clinical study

US approves 1st vaccine against chikungunya virus: All you need to know

Symptoms of chikungunya can sometimes last for months or even years, but the virus is rarely fatal

Glenmark gets USFDA nod to market generic version of Otezla tablets

Glenmark's current portfolio includes a total of 188 products that have been authorised for distribution in the US marketplace

Lupin receives tentative approval from US FDA for apalutamide tablets

Lupin develops and commercialises a wide range of branded and generic formulations, biotechnology products, and Active Pharmaceutical Ingredients (APIs) in over 100 markets

Sun Pharma, Aurobindo recall drugs from US market due to mfg issues

Leading drug makers Sun Pharmaceutical Industries and Aurobindo Pharma are recalling products from the US market due to manufacturing issues, according to the US Food & Drug Administration. As per the latest Enforcement Report issued by the American health regulator, a US-based subsidiary of Mumbai-based Sun Pharma is recalling 69,707 cartons of Cequa (cyclosporine ophthalmic solution) from the US market. The medication is used for the treatment of dry eyes. New Jersey-based Sun Pharmaceutical Industries Inc is recalling the product for being "Subpotent', USFDA stated. The company initiated the nationwide (US) Class III recall on September 7 this year. As per the USFDA, a Class III recall is initiated in a "situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences". The US health regulator stated that Aurobindo Pharma is recalling 9,890 bottles of Rasagiline Tablets, a medication indicated for the treatment of Parkinson's ..

FDA has accepted NDA for dermatological drug Deuruxolitinib: Sun Pharma

Sun Pharmaceutical Industries Ltd said that it had submitted an 8mg twice-daily regimen of deuruxolitinib for FDA review