Us Food And Drug Administration

Lupin gets USFDA nod for generic kidney disease treatment drug Tolvaptan

Pharma major Lupin Ltd on Thursday said it has received approval from the US health regulator for its generic version of Tolvaptan tablets indicated for a certain type of kidney disease. The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Tolvaptan tablets of strengths 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg, Lupin said in a regulatory filing. These are bioequivalent to Jynarque tablets in the same strengths of Otsuka Pharmaceutical Company Ltd, it added. "Lupin is the exclusive first-to-file for this product and is eligible for 180 days of generic drug exclusivity. This product will be manufactured at Lupin's Nagpur facility and will be launched soon," the company said. Commenting on the approval, Lupin CEO Vinita Gupta said,"This marks a significant entry into the nephrology segment and demonstrates our commitment to addressing the unmet needs of patients globally." Tolvaptan is indicated to slow kidney function decline in .

US govt will work with food makers to stop use of artificial dyes

Food and Drug Administration Commissioner Marty Makary said Tuesday that the agency would work with the industry to eliminate six synthetic dyes by the end of 2026

Cipla gets USFDA nod to market generic version of cancer drug Abraxane

Drug major Cipla on Friday said it has received approval from the US health regulator to market a generic cancer treatment drug. The company has received the final approval from the US Food and Drug Administration (USFDA) for the Abbreviated New Drug Application (ANDA) submitted for paclitaxel protein-bound particles for injectable suspension (albumin-bound), 100 mg/vial, single-dose vial, Cipla said in a regulatory filing. Cipla's protein-bound paclitaxel is a generic therapeutic equivalent version of Bristol Myers Squibb's Abraxane for injectable suspension 100 mg/vial. Protein-bound paclitaxel is indicated for the treatment of metastatic breast cancer, locally advanced or metastatic non-small cell lung cancer and metastatic adenocarcinoma of the pancreas. The product is expected to be launched in the first half of the current fiscal year in the US, the Mumbai-based drugmaker said. Shares of the company were trading 2.73 per cent up at Rs 1,454.90 apiece on the BSE.

US health department mass layoffs begin as RFK Jr orders 10,000 job cuts

Among those cut were Peter Stein, a top official at the Food and Drug Administration who oversaw reviewers that evaluate new drugs

US drug stocks fall as FDA vaccine chief ousted amid Trump health overhaul

The pharma and biotech sector has been under pressure since Donald Trump returned to the White House earlier this year

USFDA flags Granules India for storage, equipment lapses at Telangana plant

The US health regulator has pulled up Granules India for failing to maintain buildings for drug storage and avoiding adequate procedures regarding cleaning and maintenance of equipment at its Telangana-based formulations plant. In a warning letter to the company's Chairman and Managing Director Krishna Prasad Chigurupati, the US Food and Drug Administration (USFDA) stated that the company failed to establish and follow adequate written procedures for maintaining equipment at the Medchal-Malkajgiri-based manufacturing facility. The USFDA inspected the facility from August 26 to September 6, 2024. "Our investigators observed significant contamination in multiple ducts of non-dedicated use in the preparation of finished drug products manufactured at your facility," the USFDA stated. While filters were installed to prevent contamination, inadequate cleaning and maintenance processes rendered them ineffective, it added. "Swab samples collected from the ducts by your firm during the ...

Drug compounders sue FDA over removal of Wegovy, Ozempic from shortage list

The lawsuit claims the FDA's finding that there was no longer a shortage of the drugs' active ingredient semaglutide was arbitrary and capricious

FDA begins to rescind firings, calls some probationary staff back to work

Some of the calls were made to former employees in the Center for Devices and Radiological Health, the office responsible for overseeing medical devices and digital health products

FDA staff reviewing Musk's Neuralink among the employees fired by DOGE

The cuts included about 20 people in the FDA's office of neurological and physical medicine devices, several of whom worked on Neuralink

Lupin receives USFDA approval to market its generic HIV medications

Drug firm Lupin on Friday said it has received approval from the US health regulator to market a generic HIV medication in the US market. The company has received tentative approval from the US Food and Drug Administration (USFDA) under the US President's Emergency Plan for AIDS Relief (PEPFAR) for Abacavir, Dolutegravir and Lamivudine tablets, the Mumbai-base drug maker said in a statement. The company's product is a generic equivalent of ViiV Healthcare Company's Triumeq PD tablets for oral suspension, it added. This product would be manufactured at the drug firm's Nagpur facility and will be supplied to low-and middle-income countries, it said. The fixed-dose combination of Abacavir 60 mg/Dolutegravir 5 mg/Lamivudine 30 mg tablets for oral suspension is a once-daily single-pill regimen, indicated for the treatment of HIV-1 infection in pediatric patients aged at least 3 months and weighing at least 6 kg. "The tentative approval from the USFDA for our Abacavir, Dolutegravir and

Indian pharma improves compliance with USFDA; fewer OAI cases in 2024

Recent USFDA data reveals a decline in the number of adverse classification outcomes of inspections

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 ..

US FDA declines to approve injection form of J&J's lung cancer drug

The FDA's so-called complete response letter was related to observations as part of a standard pre-approval inspection at a manufacturing facility

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