Us Food And Drug Administration

US drug body approves Merus' therapy for lung, pancreatic cancer patients

The therapy, branded as Bizengri, targets the NRG1 gene, which is associated with formation and progression of several tumors

Marksans Pharma gets USFDA nod for allergic rhinitis treatment tablets

Marksans Pharma Ltd on Friday said it has received final approval from the US health regulator for its generic version of Loratadine tablets indicated in the treatment of allergic rhinitis. The approval by the US Food and Drug Administration (USFDA) is for the company's abbreviated new drug application (ANDA) for Loratadine tablets of strength 10 mg, Marksans Pharma said in a regulatory filing. Loratadine tablets are indicated for the treatment of allergic rhinitis caused by pollen and upper respiratory tract allergy for over-the-counter (OTC) use. This product is a generic version of Clartin tablet in the same strength as Bayer Healthcare, the company added. Loratadine is an antihistamine that treats symptoms such as itching, runny nose, watery eyes, and sneezing from "hay fever" and other allergies, it added.

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

Dr Reddy's recalls over 330k bottles of generic drug in US: USFDA

Dr Reddy's Laboratories is recalling over 3.3 lakh bottles of a medication used to treat high calcium levels in the blood and hyperparathyroidism in the US market due to manufacturing issues. According to the latest Enforcement Report by the US Food and Drug Administration, Dr Reddy's is recalling the 3,31,590 bottles of Cinacalcet tablets in multiple strengths in the American market due to CGMP (current good manufacturing practice) deviations. The recall is due to the "presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit", it added. New Jersey-based Dr Reddy's Laboratories, Inc., a unit of Hyderabad-based drug major, is recalling 2,85,126 bottles of Cinacalcet tablets in 30 mg strength. Besides, the drug maker is recalling 35,880 and 10,584 bottles of 60 mg and 90 mg strengths, respectively, USFDA said. The affected lot has been produced in India, it added. US-based Dr Reddy's Laboratories, Inc. initiated the Class II nationwide (US) recall on October 9

McDonald's attempts to reassure buyers after deadly E coli outbreak

McDonald's said on Wednesday that consumers should feel confident ordering from its restaurants despite a deadly E. coli outbreak linked to its Quarter Pounders. McDonald's US President Joe Erlinger said in an interview on the Today show that the company has removed the Quarter Pounder from its menu in the 10 states where dozens of people were sickened, as well as in several other states. What's important today is that we've taken the action to protect the American public and promote public health, Erlinger said. We're confident that we'll see our way through this and will restore confidence for the American consumer to come to McDonald's." The US Centres for Disease Control and Prevention reported the outbreak late Tuesday. It said 49 infections were reported between September 27 and October 11 in Colorado, Iowa, Kansas, Missouri, Montana, Nebraska, Oregon, Utah, Wisconsin and Wyoming. One person in Colorado died and 10 people were hospitalised. All of them mentioned eating Quarte

Eli Lilly wants records of people who took copies of its weight-loss drug

The Food and Drug Administration has listed an ongoing shortage of Lilly's medicines since December 2022

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

Zydus Lifesciences hits all time high on USFDA nod for drug worth $2 Bn

Zydus Lifesciences stock surged as much as 2.61 per cent, hitting its all time high at Rs 1,313.05 per share on the BSE in Friday's intraday deals

Alembic Pharma receives USFDA nod for Bromfenac Ophthalmic Solution

The drug is expected to be manufactured in Alembic's manufacturing facilities in Gujarat, according to sources close to the company

Indian pharma sites outpace global standards in USFDA inspections for 2023

The USFDA categorised 13 per cent (19 out of 145 inspections) of Indian facilities as 'Official Action Indication'(OAI), which is lower than the global average of 15 per cent OAIs

US lawmakers question FDA's drug inspection programme in India and China

Three top American lawmakers have questioned the foreign drug inspection programme of the Food and Drug Administration in India and China. In a letter to FDA Commissioner Robert Califf, the lawmakers on Monday wrote that the difference in inspection outcomes appears to be just another example of institutional weaknesses and dysfunction in the FDA's foreign drug inspection programme. The letter dated June 21 was written by House Energy and Commerce Committee Chair Cathy McMorris Rodgers, Subcommittee on Health Chair Brett Guthrie, and Subcommittee on Oversight and Investigations Chair Morgan Griffith following the analysis of the outcomes of FDA inspections in India and China from January 2014 to April 2024. The results of this analysis were surprising, revealing tremendous variation in inspection outcomes. Some FDA inspectors found compliance issues during all or almost all of their inspections. Other inspectors rarely reported finding a single compliance issue. Two inspectors never

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 ..

Lupin recalls 51k bottles of generic drug due to defective containers in US

Drug firm Lupin is recalling over 51,000 bottles of a generic antibiotic medication in the US market due to a "defective container", according to the American health regulator. The US-based arm of the drug maker is recalling 51,006 bottles of Cefdinir for Oral Suspension (250 mg/5 mL) due to "defective container: lack of seal integrity," US Food and Drug Administration (USFDA) said in its latest Enforcement Report. Cefrine Oral Suspension is indicated for the treatment of a range of bacterial infections. The affected lot has been manufactured at Lupin's Mandideep-based plant and marketed in the US by Baltimore-based Lupin Pharmaceuticals, Inc, it said. The drug maker initiated the Class II nationwide (US) voluntary recall on May 8 this year. As per the USFDA, a Class II recall is initiated in a situation in which the 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

USFDA issues 'warning letter' to Kilitch Healthcare over GMP violation

The FDA questioned Kilitch's quality system, citing concerns about its ability to ensure data accuracy and integrity for drug safety

Lupin gets USFDA nod to market generic hyperuricemia treatment drug

Pharma major Lupin Ltd on Thursday said it has received approval from the US health regulator to market its generic Febuxostat tablets, indicated for the chronic management of hyperuricemia in adult patients with gout. The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Febuxostat tablets of strengths 40 mg and 80 mg, a generic equivalent of Uloric tablets, 40 mg and 80 mg, of Takeda Pharmaceuticals USA, Inc, Lupin said in a regulatory filing. The product will be manufactured at the company's Pithampur facility in India, it added. The company said Febuxostat tablets of strengths 40 mg and 80 mg are indicated for the chronic management of hyperuricemia (elevated serum uric acid level) in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol; who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. Febuxostat tablets had estimated annual sales of U

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.

Aurobindo Pharma receives USFDA approval to manufacture Darunavir tablets

Darunavir Tablets, 600 mg, and 800 mg, in combination with other antiretroviral agents, are indicated for the treatment of (HIV-1) infection in adult and pediatric patients 3 years of age and older

Ryzneuta for chemotherapy-induced neutropenia receives USFDA approval

Acrotech Biopharma is preparing to commercialise Ryzneuta in the United States in the near future

US FDA approves NDA for Sun Pharma's alopecia drug Deuruxolitinib

Sun Pharma's NDA submission comprised data from two Phase-III trials, 'THRIVE-AA1' and 'THRIVE-AA2,' involving over 1,200 patients across more than 135 clinical trial sites

Torrent Pharmaceuticals gets EIR from USFDA for Gujarat's Dahej facility

The Dahej facility manufactures Active Pharmaceutical Ingredients (APIs) and formulations for Torrent Pharma's international markets