Usfda

Popular weight-loss drugs shouldn't carry suicide warnings, FDA says

Federal regulators have told drugmakers Novo Nordisk and Eli Lilly to remove label warnings about potential suicidal thoughts and behaviours from their blockbuster weight-loss medications. The US Food and Drug Administration on Tuesday said a comprehensive review found no increased risk related to suicide among users of the GLP-1 drugs for obesity, including Novo Nordisk's Wegovy and Saxenda and Eli Lilly's Zepbound. A preliminary review in January 2024 showed no link between the drugs and suicidal thought or actions, the FDA said. At that time, however, officials said they could not rule out that a small risk may exist. The new analysis puts those concerns to rest. Labeling for other drugs known as GLP-1 receptor agonists approved to treat diabetes carried no such warnings, the agency noted. Today's FDA action will ensure consistent messaging across the labelling for all FDA-approved GLP-1 RA medications, officials said.

Granules India gets USFDA tentative nod for generic ADHD treatment tablets

Granules India Ltd on Thursday said its arm Granules Pharmaceuticals, Inc has received tentative approval from the US health regulator for its generic amphetamine extended-release tablets indicated for treatment of attention deficit hyperactivity disorder, with eligibility of 180-day exclusivity. The tentative approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of Amphetamine extended-release tablets in strengths of 5 mg, 10 mg, 15 mg, and 20 mg, Granules India Ltd said in a regulatory filing. These are the generic equivalent of DYANAVEL XR, it added. "The Granules ANDA has been determined to be eligible for 180-day exclusivity by the FDA, reinforcing its growing capabilities in developing and commercialising complex and differentiated generic products for the US market," the company said. The product is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) and has an estimated market size of USD 41 ...

Indian pharma companies see sharp drop in adverse USFDA findings in 2025

OAI cases nearly halve in 2025, overall inspection volumes also fell 25%

Sun Pharma unit recalls 17,000-plus bottles of antifungal shampoo in US

The USFDA said the affected batch of Taro shampoos failed to meet impurity or degradation specifications

Granules India gets approval from USFDA for generic ADHD medication

Drug firm Granules India on Monday said it has received approval from the US health regulator to market a generic medication for attention deficit hyperactivity disorder. Granules Pharmaceuticals Inc, a wholly-owned subsidiary of the company, has received tentative approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Amphetamine extended-release orally disintegrating tablets in multiple strengths, the company said in a statement. The company's product is the generic equivalent of Adzenys XR-ODT, it added. The product will be manufactured at Granules' US-based facility located in Chantilly, Virginia. The medication is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and has an estimated market size of around USD 172 million according to IQVIA (IMS Health). Currently, the market has only one approved generic and one authorised generic, positioning Granules favourably to expand access to this crit

USFDA issues Form 483 with five observations to Aurobindo's Pharma unit

Aurobindo Pharma on Thursday said the US health regulator has issued a Form 483 with five observations after inspecting Andhra Pradesh-based Unit-IV of its subsidiary APL Healthcare. The US Food and Drug Administration (USFDA) inspected the unit from December 8 to December 17, 2025, the Hyderabad-based drug firm said in a regulatory filing. "At the end of the inspection, a 'Form 483' was issued with 5 observations which are procedural in nature, and we will respond to the US FDA within the stipulated timelines," it added. The company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe, the drug firm said. As per the US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. Shares of Aurobindo Pharma were trading 0.83 per ..

Zydus Life's US arm gets FDA nod for Menkes disease drug resubmission

The drug, CUTX-101, is intended for the treatment of Menkes disease, a rare X-linked recessive genetic disorder affecting male children

USFDA preparing to issue 'black box' warning on Covid-19 vaccines

A black box warning is the strongest caution for prescription drugs and is usually reserved for alerting patients to possible adverse reactions that could lead to death or serious injury

Alembic gets USFDA nod for generic eye infection treatment suspension

Alembic Pharmaceuticals Ltd on Thursday said it has received final approval from the US health regulator for its generic version of Loteprednol Etabonate and Tobramycin ophthalmic suspension used for treatment of eye infection. The approval granted by the US Food & Drug Administration (USFDA) for the Abbreviated New Drug Application (ANDA) Loteprednol Etabonate and Tobramycin Ophthalmic Suspension of strength 0.5 per cent/0.3 per cent (5 mL and 10 mL), Alembic Pharmaceuticals Ltd said in a regulatory filing. Alembic was granted a Competitive Generic Therapy (CGT) designation for this application. With this approval, Alembic is eligible for 180 days of CGT exclusivity upon commercialisation, it added. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5 per cent/0.3 per cent, of Bausch & Lomb Incorporated, the company said. Loteprednol etabonate and tobramycin ophthalmic suspension, 0.5 per cent/0.3 per cent, is ...

Sun Pharma Advanced Research zooms 20% on huge volumes; details here

Till 01:44 PM; as many as a combined 27.7 million equity shares representing 8.5 per cent of the total equity of pharmaceutical company have changed hands on the NSE and BSE.

Wockhardt soars 19% on huge volumes; here's why the pharma stock rose today

The company said the United States Food and Drug Administration (USFDA) has formally accepted the New Drug Application (NDA) for its first-in-class antibiotic 'Zaynich'

Lupin gets US FDA nod for its first biosimilar drug Pegfilgrastim

The product, a biosimilar to Amgen's popular drug Neulasta, will be manufactured at Lupin's biotech facility in Pune

Zydus gets USFDA's orphan drug designation for beta-thalassemia product

Zydus Lifesciences on Thursday said the US health regulator has granted Orphan Drug Designation (ODD) to Desidustat, a novel product for the treatment of beta-thalassemia. The US Food and Drug Administration (USFDA) grants orphan status to support development of medicines for the treatment of rare diseases that affect fewer than 2 lakh people in the US. "This Orphan Drug Designation from the USFDA underlines the urgent medical need to develop Desidustat to address beta-thalassemia," Zydus Lifesciences MD Sharvil Patel said in a regulatory filing. Beta thalassaemia patients have low levels of haemoglobin, which results in a lack of oxygen in many parts of the body, leading to weakness, fatigue and more serious complications. Treatment for people with beta thalassaemia often requires lifelong regimens of chronic blood transfusions for survival and treatment for iron overload due to the transfusions. Desidustat is a hypoxia inducible factor (HIF)-prolyl hydroxylase inhibitor (PHI) an

FDA's top drug regulator resigns after officials probe 'serious concerns'

The head of the Food and Drug Administration's drug centre abruptly resigned on Sunday after federal officials began reviewing serious concerns about his personal conduct, according to a government spokesperson. Dr George Tidmarsh, who was named to the FDA post in July, was placed on leave Friday after officials in the Department of Health and Human Services' Office of General Counsel were notified of the issues, HHS press secretary Emily Hilliard said in an email. Tidmarsh then resigned on Sunday morning. Secretary Kennedy expects the highest ethical standards from all individuals serving under his leadership and remains committed to full transparency, Hilliard said. The departure came the same day that a drugmaker connected to one of Tidmarsh's former business associates filed a lawsuit alleging that he made false and defamatory statements during his time at the FDA. The lawsuit, brought by Aurinia Pharmaceuticals, alleges that Tidmarsh used his FDA position to pursue a longstand

Glenmark recalls product in US over manufacturing issue: USFDA

Drugmakers Glenmark and Dr Reddy's Laboratories are recalling products in the US due to manufacturing issues, according to the US Food and Drug Administration (USFDA). As per its latest Enforcement Report, the US health regulator noted that a US-based unit of Glenmark Pharmaceuticals is recalling 26,928 packs of oral contraceptive medication in the US. Mahwah, New Jersey-based Glenmark Pharmaceuticals Inc, USA is recalling the affected lot of Viorele, Desogestrel and Ethinyl Estradiol (USP, 0.15 mg/ 0.02 mg) and Ethinyl Estradiol tablets due to "failed impurities/degradation specifications." The affected lot was produced at Mumbai-headquartered drug maker's Goa manufacturing facility. The drug firm issued the Class II nationwide recall on September 3, 2025. USFDA stated that a US-based subsidiary of Dr Reddy's Laboratories is recalling the medication used to provide muscle relaxation during surgery. Princeton, New Jersey-based Dr. Reddy's Laboratories, Inc is recalling 571 vials o

Dr Reddy's, Zydus recall products in US over manufacturing issues: USFDA

Drug majors Dr Reddy's Laboratories and Zydus Lifesciences are recalling products in the US for manufacturing issues, according to the US health regulator. In its latest Enforcement Report, US Food and Drug Administration (USFDA) stated that an American subsidiary of the Hyderabad-based drug major is recalling 571 vials of an injection used to relax muscles. Princeton-based Dr Reddy's Laboratories, Inc is recalling the affected lot of Succinylcholine Chloride Injection due to "Out-of-Specification result during the six-month stability testing," the USFDA stated. The company initiated the nationwide (US) Class II recall on September 26 this year. The USFDA stated that US-based arm of Zydus Lifesciences is recalling over 1,500 boxes of an antiviral medication used primarily to treat chronic hepatitis B virus. Pennington, New Jersey-based Zydus Pharmaceuticals (USA) Inc is recalling 912 and 600 bottles of Entecavir tablets in strengths of 0.5 mg and 1 mg respectively due to "failed .

Biocon gets USFDA's tentative approval for antibacterial drug Rifaximin

The USFDA's tentative approval means Biocon Pharma's Rifaximin 550 mg meets regulatory requirements but cannot be marketed in the US yet due to patents or exclusivity on the original drug

Wockhardt files new drug application with USFDA for antibacterial drug

Drug firm Wockhardt on Wednesday said it has submitted a new drug application for its novel antibacterial drug with the US health regulator. The company has submitted a New Drug Application (NDA) to the US Food and Drug Administration (USFDA) for its novel antibacterial agent Zidebactam-Cefepime injection, the Mumbai-based drugmaker said in a regulatory filing. The NDA seeks approval for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, with or without concurrent bacteremia caused by Gram-negative bacteria, including multidrug-resistant (MDR), it added. In the US and EU, more than 8 million cases of cUTI are reported every year, reflecting the global burden of Gram-negative infections, the drug firm stated. "This milestone marks the first-ever NDA submission to the US FDA for a drug, fully discovered and developed by an Indian pharmaceutical company, a momentous achievement for Indian innovation," Wockhardt Ltd said. The NDA submission follows

Trump to launch 'TrumpRx', to make drugs cheaper for Americans, says report

After talks with US President Donald Trump, global pharma giant Pfizer is further expected to announce a $70 billion investment in research, development and domestic manufacturing

Glenmark, Zydus recall products in US over manufacturing issues: USFDA

Domestic drugmakers Glenmark, Granules India, Sun Pharma, Zydus and Unichem are recalling products in the US market for various manufacturing issues, according to the US Food and Drug Administration (USFDA). The drugmakers are voluntarily recalling affected lots in the American market, the US health regulator said in its latest Enforcement Report. A US-based subsidiary of the Mumbai-based Glenmark Pharmaceuticals is recalling 13,824 Azelaic Acid Gel tubes produced at the company's Goa plant due to "CGMP deviations" following market complaints received for gritty texture, USFDA said. New Jersey-based Glenmark Pharmaceuticals Inc, USA, initiated the Class II nationwide recall on September 17. As per the USFDA, a Class-II recall is initiated when the use of, or exposure to, a violative product may lead to temporary or medically reversible health consequences, or when the likelihood of serious adverse health outcomes is minimal. Hyderabad-based Granules India is recalling over 49,000