US FDA

The firm ran into trouble after the US FDA informed it of 55 cases of adverse events on the use of its eye drops, some of which caused permanent loss of vision and at least one caused death

Drug firm Zydus Lifesciences is recalling over 55,000 bottles of generic medication in the US market due to failed impurities specifications. As per the latest enforcement report by the US Food and Drug Administration (USFDA), Zydus Pharmaceuticals (USA) Inc is recalling 21,936 (30 count) and 33,096 (100 count) bottles of Colchicine tablets, which are used to treat gout. The affected lot is manufactured by Ahmedabad-based Zydus Lifesciences and marketed in the US by New Jersey-based Zydus Pharmaceuticals (USA) Inc. USFDA said the company is recalling the product due to "failed impurities/ degradation specifications". An out-of-specification (OOS) result was observed during release testing of one lot for a related substance, i.e. Beta-lumicolchicine, it added. Zydus commenced the Class III recall on February 24 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 ...

The US Food and Drug Administration (FDA) rejected Elon Musk-run company Neuralink's bid to implant a chip in a human brain over safety risks, the media reported.

Global Pharma has initiated a voluntary recall at the consumer level of all unexpired lots of EzriCare Artificial Tears and Delsam Pharma's Artificial Tears

The agency seeks more information about the specific raw materials used and whether they were obtained from any of the same suppliers

Company aims to onboard one million patients the platform, which aims to help them improve heart health through doctor-connected online and offline modules

Executives at cultivated meat firms are optimistic that meat grown in massive steel vats could be on the menu within months after a company won the go-ahead from a key regulator

The Michigan plant came to national attention in 2022 after FDA, while fielding reports of infants sickened by formula produced there, found strikingly unsanitary co

Pharmaceutical firm Lupin on Monday said it has received tentative approval from the US health regulator to market its generic version of Dolutegravir and Rilpivirine tablets used in treatment of HIV infection. The tentative approval granted by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of Dolutegravir and Rilpivirine tablets of strength 50 mg/25 mg, Lupin said in a regulatory filing. The Dolutegravir and Rilpivirine tablets, 50 mg/25 mg had estimated annual sales of USD 666 million in the US, the company said citing IQVIA MAT September 2022 data.

The Food and Drug Administration on Tuesday finalised a rule change that allows women seeking abortion pills to get them through the mail, replacing a long-standing requirement that they pick up the medicine in person. The Biden administration implemented the change last year, announcing it would no longer enforce the dispensing rule. Tuesday's action formally updates the drug's labelling to allow women to get a prescription via telehealth consultation with a health professional, and then receive the pills through the mail, where permitted by law. Still, the rule change's impact has been blunted by numerous state laws limiting abortion broadly and the pills specifically. Legal experts foresee years of court battles over access to the pills, as abortion-rights proponents bring test cases to challenge state restrictions. For more than 20 years, the FDA labelling had limited dispensing to doctor's offices and clinics, due to safety concerns. During the COVID-19 pandemic, the FDA ...

The USFDA had imposed an import ban on the Halol plant in December 2015 too

Gross sales came in at Rs 10,809.2 crore, growing by 13.1% over Q2 last year

Alembic Pharmaceuticals Ltd on Tuesday said the US health regulator has issued a Form 483 with four procedural observations after inspection of its oncology injectable formulation facility at Panelav in Gujarat. 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. The USFDA had conducted an inspection at the facility located at Panelav from October 4, 2022, to October 14, 2022, Alembic Pharmaceuticals said in a regulatory filing. "The USFDA issued a Form 483 with 4 procedural observations. None of the observations is related to data integrity, and management believes that they are addressable," it added. The company further said it is preparing the response to the observations, which will be submitted to the USFDA within the stipulated period.

The US Food and Drug Administration (FDA) has authorised the updated Moderna and Pfizer-BioNTech Covid-19 booster shots for children as young as five

Drug firm Lupin on Tuesday said it has received an approval from the US health regulator to market Darunavir Tablets, used to treat Human Immunodeficiency Virus (HIV) infection, in the American market. The Mumbai-based company said it is the exclusive first filer for 800 mg tablets and is eligible for 180-day exclusivity. Lupin will also potentially have shared 180-day exclusivity on the 600 mg tablets, it added. The company has received the approval from the US Food and Drug Administration (USFDA) for the medication in strengths of 600 mg and 800 mg, Lupin said. The drug firm's product is a generic equivalent of Janssen Products' Prezista Tablets. As per MAT June 2022 data, Darunavir tablets (600 mg and 800 mg) had estimated annual sales of USD 343 million in the US. Lupin shares were trading 2.17 per cent up at Rs 738.30 apiece on the BSE.

Drug firm Lupin on Thursday said it has received a warning letter from the US health regulator for its Tarapur-based manufacturing facility in Maharashtra. The US Food and Drug Administration (USFDA) inspected the site from March 22, 2022 to April 4, 2022. The company manufactures both fermentation-based and synthetic APIs (active pharmaceutical ingredients) at the plant. "The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility," the Mumbai-based company said in a regulatory filing. The drug firm is committed to addressing the concerns raised by the USFDA and will work with the agency to resolve the issues at the earliest, it added. Lupin did not share details about the issues flagged by the US health regulator. A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations. The letter identifies the violation, such as

The company has launched the tablets in strengths of 5 mg, 20 mg and 40 mg after having received an approval from the United States Food and Drug Administration earlier, Lupin Ltd said in a statement

Lupin said it does not believe the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility

The Food and Drug Administration has acknowledged that its response to the US infant formula shortage was slowed by delays in processing a whistleblower complaint and test samples from the nation's largest formula factory. A 10-page report from the agency on Tuesday offers its first formal account of the factors that led to the ongoing shortage, which has forced the US to airlift millions of pounds of powdered formula from overseas. The review zeroed in on several key problems at the agency, including outdated data-sharing systems, inadequate staffing and training among its food inspectors, and poor visibility into formula supply chains and manufacturing procedures. For things that are critical to the public health, if you don't have some understanding of how all the pieces fit together, then when you get into a crisis or a shortage you have a real problem, FDA Commissioner Robert Califf told The Associated Press in an interview. To a large extent that's what happened here. Califf

Pharmaceuticals firm Lupin Ltd on Friday said it has launched the generic sodium sulfate, potassium sulfate and magnesium sulfate oral solution, used for cleansing colon as a preparation for colonoscopy, in the US market following approval from the country's health regulator. The approval by the US Food and Drug Administration (USFDA) is for sodium sulfate, potassium sulfate and magnesium sulfate oral solution of strength 17.5 g/3.13 g/1.6 g per 6 ounces, Lupin Ltd said in a regulatory filing. The approved oral solution is a generic equivalent of Suprep Bowel Prep Kit Oral Solution, 17.5 g/3.13 g/1.6 g per 6 ounces, of Braintree Laboratories Inc, it added. The solution had an estimated annual sales of USD 202 million in the US, the company said citing IQVIA MAT July 2022 data.