Page 5 - Us Fda

US FDA rejected Musk-run Neuralink's bid to implant chip in human brain

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.

CDSCO probes Indian eyedrops after US FDA flags contamination risk

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

US FDA joins global regulators probing tainted overseas cough syrup

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

Lupin Digital launches Lyfe, a 24x7 monitoring ecosystem for heart patients

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

Once science fiction, lab-grown meat coming to US restaurants this year

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

Abbott faces criminal investigation over baby formula, says report

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

Lupin gets USFDA tentative nod for generic drugs to treat HIV infection

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.

US FDA finalises rule allowing women to get abortion pills via mail-order

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 ...

Sun Pharmaceuticals' Halol plant gets 'import alert' from USFDA

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

Sun Pharma Q2 PAT rises 10.5% YoY to Rs 2,262 crore on robust sales

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

USFDA issues four observations to Alembic Pharma's Panelav plant

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.

US FDA authorises updated Moderna, Pfizer Covid boosters for children

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

Lupin gets USFDA nod to market generic HIV drug Darunavir tablets

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.

Lupin gets warning letter from USFDA for Tarapur API plant in Maharashtra

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

Lupin receives approval from US FDA for Sildenafil for Oral Suspension

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 dips 3% as US FDA issues warning letter for Tarapur facility

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

FDA acknowledges delays in response to US Infant formula shortage

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

Lupin receives US FDA approval for kit used in colonoscopy preparation

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.

US FDA issues 11 observations each for two sites in Bengaluru: Biocon

Biocon Ltd on Wednesday said the US health regulator has issued Form 483s with 11 observations each for two sites in Bengaluru and six observations for a plant in Malaysia, following inspection of seven manufacturing facilities of its arm Biocon Biologics. As per 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 conducted three on-site inspections of Biocon Biologics' seven manufacturing facilities spanning two sites in Bengaluru, India and one at Johor, Malaysia, Biocon said in a regulatory filing. The inspections started with the Bengaluru site on August 11, 2022 and concluded with the Malaysia site on August 30, 2022, it added. "At the conclusion of these inspections, the agency has issued Form 483s with 11 observations each for the two sites in Bengaluru and six .

Zydus gets USFDA nod for generic version of Venlafaxine, Pregabalin

Zydus Lifesciences Ltd on Wednesday said it has received final approval from the US health regulator to market its generic version of venlafaxine extended-release tablets used to treat depression. The company also said the US Food and Drug Administration (USFDA) has granted final approval for pregabalin extended-release tablets used to treat pain caused by nerve damage due to diabetes or shingles (herpes zoster) infection. The approval granted by the USFDA for venlafaxine extended-release tablets is for strengths of 37.5 mg, 75 mg, 150 mg and 225 mg, Zydus Lifesciences said in a regulatory filing. Venlafaxine is used to treat depression, anxiety, panic attacks and social anxiety disorder. It had annual sales of USD 46 million in the US, the company said citing IQVIA MAT July 2022. Further, Zydus Lifesciences said the final approval granted by the USFDA to market pregabalin extended-release tablets is for strengths of 82.5 mg, 165 mg and 330 mg. The drug had annual sales of USD 3 ..