Page 6 - Us Fda

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 ..

Explained: What is the controversy around J&J's talc-based baby powder?

Johnson and Johnson (J&J) has been facing several thousand lawsuits from women who claim that they developed ovarian cancer after using the product

Lupin gets USFDA approval to market generic cancer treatment drug

Lupin on Monday said it has received a tentative approval from the US health regulator to market Dasatinib tablets, used to treat certain types of cancer, in America. The company in partnership with Pharmascience Inc. has received approval from the US Food and Drug Administration (FDA) for Dasatinib tablets in strengths of 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, it said in a statement. The Mumbai-based drug maker's product is a generic version of Bristol-Myers Squibb Company's Sprycel tablets. As per IQVIA MAT data, Dasatinib tablets had an estimated annual sale of USD 1,569 million in the US. Shares of Lupin settled at Rs 662.50 apiece, up 1.49 per cent on the BSE.

Aurobindo Pharma subsidiary's plant gets one observation from USFDA

Aurobindo Pharma on Monday said the US health regulator has issued one observation after inspecting a plant owned by its US-based unit. The US Food and Drug Administration (USFDA) conducted its Pre-Approval Inspection (PAl) and GMP (Good Manufacturing Practice) inspection from August 22-26 of Raleigh-based plant which has been set up for manufacturing MOl (Metered Dose Inhalers) and derma products, the Hyderabad-based drug firm said in a regulatory filing. The plant is owned by Aurolife Pharma LLC, a wholly-owned step down subsidiary of the company, it added. "At the end of the inspection, Aurolife has been issued a 'Form 483' with 1 observation and the observation is procedural in nature and there are no data integrity issues," Aurobindo Pharma said. The company will respond to the USFDA within the stipulated timeline, it added. As per USFDA, Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that in its

Still possible to control monkeypox outbreak, says former FDA chief

Former US Food and Drugs Administration (FDA) chief Scott Gottlieb said that the response to the virus has to be wider to control it, though.

Monkeypox endemic in US can be worst public health failure: Ex-FDA director

Monkeypox becoming endemic in the US would be the "worst public health failure in modern times" because it could have been prevented, says former FDA director Scott Gottlieb

Alembic Pharma receive USFDA approval to market drug for skin treatment

Alembic Pharmaceuticals on Friday said its subsidiary has received approval from the US health regulator to market medication for treating actinic keratoses

Glenmark Pharma arm gets final USFDA nod for birth control capsules

Glenmark Pharmaceuticals Ltd on Friday said its US arm has received final approval from the US health regulator for its generic Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate birth control capsules. The approval granted by the US Food & Drug Administration (USFDA) to Glenmark Pharmaceuticals Inc is for Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules of strength 1 mg/20 mcg, the company said in a statement. It is the generic version of Taytulla capsules of Allergan Pharmaceuticals International Ltd, it added. Citing IQVIA sales data for the 12 months ended May 2022, the company said the Taytulla Capsules market achieved annual sales of approximately USD 85.9 million.

Biocon receives three US FDA observations on its Telangana plant

Biotechnology major Biocon on Thursday said the US health regulator has issued three observations after inspecting its Telangana-based manufacturing plant. The US Food and Drug Administration (USFDA) concluded a pre-approval inspection for Site 3 located at Hyderabad on July 20, Biocon Ltd said in a regulatory filing. "Three observations were cited at the end of the inspection, which we will be addressing within the stipulated time," it added. The company stands committed to quality, safety and efficacy of its products, the Bengaluru-based company said.

LIVE: Lankan Prez Gotabaya Rajapaksa headed to Saudi Arabia, says report

Live news upedates: Sri Lanka President Gotabaya Rajapaksa is headed to Saudi Arabia via Singapore

US approves eye drops that could eliminate need for reading glasses

The US has approved a new type of eye drop which they say could eliminate the need for reading glasses