Us Food And Drug Administration

Cough syrups linked to child deaths in India not shipped to US, says FDA

The US FDA said it was aware of news reports of devastating, ongoing diethylene glycol and ethylene glycol contamination in children's cough and cold medicine in India

Caplin Point's unit gets USFDA nod for generic milrinone lactate injection

Pharma firm Caplin Point Laboratories Ltd on Wednesday said its arm Caplin Steriles Ltd has received final approval from the US health regulator for its generic milrinone lactate in 5 per cent dextrose injection indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. The approval granted by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) milrinone lactate in 5 per cent Dextrose Injection of strengths 20 mg/100 mL and 40 mg/200 mL in single-dose infusion bags, Caplin Point Laboratories said in a regulatory filing. The approved injection is a generic therapeutic equivalent version of the reference listed drug PRIMACOR in dextrose 5 per cent, by Sanofi Aventis US LLC, it added. Milrinone is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure, the company said. Citing IQVIA (IMS Health) data, the company said milrinone lactate in 5 per cent ...

Alembic gets USFDA's approval for generic acne drug Tretinoin Cream

Alembic Pharmaceuticals on Monday said it has received approval from the US health regulator to market a generic medication to treat acne vulgaris in the US market. The company has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Tretinoin Cream USP (0.025 per cent), the drug maker said in a statement. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Retin-A Cream, 0.025 pr cent, of Bausch Health US, LLC, it added. Tretinoin cream is indicated for topical application in the treatment of acne vulgaris. According to IQVIA, Tretinoin cream USP, 0.025 per cent, has an estimated market size of USD 94 million for the twelve months ending June 2025. Shares of the company were trading 1.03 per cent up at Rs 968.10 apiece on BSE.

Zydus Lifesciences gets tentative USFDA nod for generic blood cancer drug

Zydus Lifesciences Ltd on Thursday said it has received tentative approval from the US health regulatory agency for its generic version of cancer treatment drug Ibrutinib tablets. The tentative approval granted by the US Food and Drug Administration (USFDA) is for Ibrutinib tablets of strengths 140 mg, 280 mg, and 420 mg, Zydus Lifesciences said in a statement. The Ibrutinib tablets will be produced at Zydus Lifesciences Ltd SEZ, Ahmedabad, it added. The company said Ibrutinib is indicated for the treatment of adult patients with different types of blood cancers, Chronic lymphocytic leukaemia (CLL)/Small lymphocytic lymphoma (SLL), and Waldenstrom's macroglobulinemia (WM). Citing IQVIA MAT May 2025, Zydus said Ibrutinib tablets had annual sales of USD 2148.9 million in the US.

FDA review of Novavax Covid-19 vaccine sparks uncertainty about other shots

The Trump administration's effort to impose new requirements on Novavax's COVID-19 vaccine -- the nation's only traditional protein-based option for the coronavirus -- is sowing uncertainty about updates to other vaccines, too. Novavax said on Monday that the Food and Drug Administration was asking the company to run a new clinical trial of its vaccine after the agency grants full approval. The company said it had responded and that it believed its shot remains "approvable". But a weekend post on social media by FDA Commissioner Marty Makary suggested the prospect of needing a new trial before the shots' yearly strain update -- something unlikely to be possible before fall. That's raised questions about whether other vaccines will be caught in the turmoil. "I don't think because there's a strain change that this is a new product," said Dr Jesse Goodman of Georgetown University, a former FDA vaccine chief. If that's the new policy, "you'd always be doing clinical trials and you'd nev

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.