Page 7 - Usfda

USFDA highlights quality concerns over drugs manufactured in India

USFDA launches QMM program to reduce drug shortages and improve supply chain issues

Indian pharma sites outpace global standards in USFDA inspections for 2023

The USFDA categorised 13 per cent (19 out of 145 inspections) of Indian facilities as 'Official Action Indication'(OAI), which is lower than the global average of 15 per cent OAIs

Regulatory action: Shock and awe

Rather than surprising investors with their final decisions, disclosing findings on an ongoing basis would better prepare the market for eventual outcomes

Indian firms fared better in USFDA inspections in recent years, says IPA

IPA bats for Revised Schedule M implementation as key to pharma manufacturing quality in India

AstraZeneca's Imfinzi fails in late-stage trial to treat lung cancer cases

Imfinzi is a human monoclonal antibody, which works to block a tumour's ability to evade and dampen the immune system, while also boosting the body's anti-cancer immune response

US lawmakers question FDA's drug inspection programme in India and China

Three top American lawmakers have questioned the foreign drug inspection programme of the Food and Drug Administration in India and China. In a letter to FDA Commissioner Robert Califf, the lawmakers on Monday wrote that the difference in inspection outcomes appears to be just another example of institutional weaknesses and dysfunction in the FDA's foreign drug inspection programme. The letter dated June 21 was written by House Energy and Commerce Committee Chair Cathy McMorris Rodgers, Subcommittee on Health Chair Brett Guthrie, and Subcommittee on Oversight and Investigations Chair Morgan Griffith following the analysis of the outcomes of FDA inspections in India and China from January 2014 to April 2024. The results of this analysis were surprising, revealing tremendous variation in inspection outcomes. Some FDA inspectors found compliance issues during all or almost all of their inspections. Other inspectors rarely reported finding a single compliance issue. Two inspectors never

Lupin, Eugia recall products from US over manufacturing issues: USFDA

Drugmaker Lupin and a unit of Aurobindo Pharma are recalling products from the American market due to manufacturing issues, according to the US health regulator. As per the latest Enforcement Report issued by the US Food and Drug Administration (USFDA), a US-based unit of Lupin is recalling a medication used to treat bacterial infections. Baltimore-based Lupin Pharmaceuticals Inc is recalling 3,552 bottles of Cefixime for Oral Suspension (USP 200 mg/5 mL) due to "failed content uniformity specifications". The affected lot has been produced at the company's Mandideep-based manufacturing plant in Madhya Pradesh. The company commenced the Class II nationwide (US) recall on May 30 this year. The US health regulator stated that New Jersey-based Eugia US LLC, a subsidiary of Aurobindo Pharma, is recalling 70,125 vials of Dexamethasone Sodium Phosphate injection USP. The company is recalling the affected lot due to "failed impurities/degradation specifications", USFDA said. Eugia com

Wanbury surges 5% after USFDA issues Zero observations for Patalganga site

At 9:55 AM, the shares were off highs, trading 2.25 per cent higher at Rs 163.95 per share. In comparison, BSE Sensex was trading 0.16 per cent lower at 77,211.40 levels.

Alembic gets USFDA nod for generic injection to treat hereditary angioedema

Alembic Pharmaceuticals Ltd on Monday said it has received final approval from the US health regulator for its generic Icatibant injection indicated for the treatment of acute attacks of hereditary angioedema in adults. The approval by the US Food & Drug Administration (USFDA) is for the Abbreviated New Drug Application (ANDA) for Icatibant injection of strengths 30 mg/3 mL (10 mg/mL) single-dose prefilled syringe, Alembic Pharmaceuticals said in a regulatory filing. This is the first peptide product approval from the USFDA received by the company, Alembic Pharma said. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Firazyr Injection, 30 mg/3 mL (10 mg/mL), of Takeda Pharmaceuticals USA, Inc, it added. Icatibant injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. Hereditary angioedema is a disorder characterised by recurrent episodes of severe swelling (angioedema)

USFDA closes inspection of Lupin's facility with zero 483 observations

The inspection of the Nagpur facility was carried out by the US drug regulator from June 10 to June 13, 2024

Zydus gets tentative nod from USFDA for blood pressure lowering drug

Zydus Lifesciences Ltd on Friday said it has received tentative approval from the US health regulator to market Azilsartan Medoxomil and Chlorthalidone tablets, which are indicated for the treatment of high blood pressure. The tentative approval by the US Food and Drug Administration (USFDA) is for Azilsartan Medoxomil and Chlorthalidone tablets of strengths 40 mg/12.5 mg and 40 mg/25 mg, Zydus Lifesciences said in a regulatory filing. Azilsartan and Chlorthalidone are diuretic combination products indicated for the treatment of high blood pressure to lower blood pressure, it added. The drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ- II, India, the company said. Azilsartan Medoxomil and Chlorthalidone tablets had annual sales of USD 77.9 million in the US, Zydus Lifesciences said citing IQVIA MAT March 2024 data.

Senators blast health, police officials over illegal sales of e-cigarettes

Senators on Wednesday blasted top health and law enforcement officials for not doing more to combat the rise of illegal electronic cigarettes in the U.S., a multibillion-dollar business that has flourished amid haphazard enforcement. Democrats and Republicans on the Senate Judiciary Committee expressed frustration and exasperation while questioning officials from the Food and Drug Administration and Justice Department about attempts to stay on top of the vaping industry, which has grown to include thousands of flavored, unauthorized e-cigarettes originating in China. Those products, including brands like Elf Bar, have become the most popular choice among American teens who vape. I simply do not understand how FDA and DOJ have permitted thousands of products to remain on store shelves when their manufacturers have not received authorization, or, in some cases, even filed an application, said the committee's chairman, Dick Durbin. The Illinois Democrat displayed a photo of a shelf ..

US FDA grants accelerated approval to Genfit, Ipsen's liver disease drug

Ipsen added that standard approval for Iqirvo may be contingent on confirmatory trials

USFDA issues Form 483 with four observations to Dr Reddy's API unit

Dr Reddy's Laboratories on Friday said the US health regulator has issued Form 483 with four observations after inspecting its Andhra Pradesh-based API manufacturing facility. The US Food & Drug Administration (USFDA) today completed a GMP inspection at the company's API manufacturing facility (CTO-6) in Srikakulam, Andhra Pradesh, the Hyderabad-based drug major said in a regulatory filing. The inspection was conducted from May 30, 2024 to June 7, 2024, it added. "We have been issued a Form 483 with four observations, which we will address within the stipulated timeline," 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.

Covid shots should target JN.1, KP.2 subvariants in 2024-25 campaign: USFDA

FDA reviewers said since the difference between JN.1 and newer subvariants such as KP.2 subvariants is not much, it is possible that vaccines developed against JN.1 may adequately protect against KP.2

Delaware judge allows more than 70,000 Zantac lawsuits to go forward

In 2019, some manufacturers and pharmacies halted Zantac sales after a chemical called NDMA, which is known to cause cancer, was detected in some pills

Sun Pharma, Dr Reddy's pull drugs in US over manufacturing issues: USFDA

Sun Pharma and Dr Reddy's Laboratories are recalling products in the American market due to manufacturing issues, the US Food and Drug Administration (USFDA) has said. In its latest Enforcement Report, the US health regulator stated that a US-based unit of Sun Pharma is recalling 35,069 bottles of medication used to treat high pressure inside the eye due to glaucoma or other eye diseases. New Jersey-based Sun Pharmaceutical Industries Inc is recalling the affected lot of Xelpros (latanoprost ophthalmic emulsion) due to "out of specification for particulate matter test". The company initiated the voluntary Class III recall in the US on April 22 this year, the USFDA stated. In a separate filing, the USFDA stated that a US-based arm of Dr Reddy's Laboratories is recalling 1,176 bottles of an immunosuppressant medication. Dr Reddy's Laboratories Inc is recalling the affected lot of Sirolimus Tablets due to "Failed Impurities/Degradation Specifications", the USFDA said. The company ...

Indian pharmaceutical companies likely to cash in on US drug shortages

US drug shortages hit a decade-high of 323 across 22 therapies in the March quarter of 2024

Aurobindo Pharma Q4 results: PAT rises 79.5% to Rs 908 cr, revenue up 14.8%

The increase in PAT is attributed to expansion into the new markets, product launches and stable pricing

Cipla receives USFDA approval to market Lanreotide injection in US

Drug major Cipla on Wednesday said it has received approval from the US health regulator to market a generic medication used to treat acromegaly and other conditions. The company has received the final approval from the US Food and Drug Administration (USFDA) to market Lanreotide injection in multiple strengths, the Mumbai-based drug maker said in a statement. The company's Lanreotide Injection is therapeutic equivalent generic version of Somatuline Depot Injection, it added. The drugmaker said its product is indicated for the treatment of patients with acromegaly and gastroenteropancreatic neuroendocrine tumours. According to IQVIA (IMS Health), Somatuline Depot had sales of around USD 898 million in the US for the 12-month period ending March 2024.