Page 3 - Usfda

Alembic Pharma gets approval from US FDA to market generic medication

Alembic Pharmaceuticals on Tuesday said it has received approval from the US health regulator to market a generic product indicated for prophylaxis of deep vein thrombosis. The company has received approval from the US Food and Drug Administration (USFDA) to market Dabigatran Etexilate Capsules (110 mg), the drug firm said in a regulatory filing. Dabigatran Etexilate Capsules are indicated for prophylaxis of deep vein thrombosis and pulmonary embolism following hip replacement surgery. The approved product is therapeutically equivalent to Boehringer Ingelheim Pharmaceuticals Inc's Pradaxa Capsules (110 mg). The company said it now has a cumulative total of 211 ANDA (abbreviated new drug application) approvals from the USFDA. Shares of the company on Tuesday closed 3.17 per cent down at Rs 1,076 apiece on the BSE.

Dr Reddy's Labs shares drop after US FDA gives VIA tag to Vizag facilities

Shares of Dr Reddy's Laboratories slipped up to 2 per cent at Rs 6,875.05 per share on the BSE in Monday's intraday trade

USFDA scrutiny delays generic drug approvals for major Indian pharma firms

Big Pharma companies Cipla, Sun Pharma, Aurobindo Pharma, Dr Reddy's, and Lupin face intense scrutiny from the US Food and Drug Administration (USFDA)

Sun Pharma receives US FDA approval for drug to treat alopecia areata

Autoimmune disorder characterised by hair loss affects some 700,000 people in the US

Sun Pharma hits all time high on US FDA nod for alopecia drug 'Leqselvi'

This came after Sun Pharmaceuticals announced that the US Food and Drug Administration (USFDA) has approved its new drug application for Deuruxolitinib, a new treatment for Alopecia Areata

Gland Pharma, Zydus Lifesciences secure USFDA approvals for key medications

Gland Pharma, a Hyderabad-based generic injectable-focused company, received tentative approval for Latanoprostene Bunod Ophthalmic Solution, 0.024 per cent

USFDA classifies inspection of Zydus unit as 'official action indicated'

Zydus Lifesciences on Thursday said the US health regulator has cautioned that its Gujarat-based injectables plant may be subject to regulatory actions. The company said it has received a report from the US Food and Drug Administration (USFDA) for the inspection conducted at its injectables manufacturing facility located at Jarod, near Vadodara, Gujarat between April 15-23, 2024. The USFDA has determined that the inspection classification of this facility is Official Action Indicated (OAI), it added. According to FDA, OAI means "objectionable conditions were found and regulatory administrative sanctions by FDA are indicated" during the inspection. "The company will work closely with the agency to resolve the regulatory status of this facility expeditiously," the drug maker said. Shares of Zydus Lifesciences settled marginally up at Rs 1,185.30 apiece on the BSE.

Glenmark Pharma receives USFDA approval for seizure treatment drug

The approval by the US Food & Drug Administration (USFDA) is for Topiramate capsules of strengths 15 mg and 25 mg, Glenmark Pharmaceuticals said in a statement

Zydus Lifesciences hits all time high on USFDA nod for multiple drugs

Shares of Zydus Lifesciences zoomed up to 1.93 per cent, hitting its all time high at Rs 1203.20 per share on the BSE in Thursday's intraday trade

Zydus Life gets USFDA approval to market heart failure treatment drug

Zydus Lifesciences Ltd on Wednesday said it has received final approval from the US health regulator to market its generic Sacubitril and Valsartan tablets combination used to treat chronic heart failure in adults. The approval by the US Food and Drug Administration (USFDA) is to market Sacubitril and Valsartan tablets of strengths 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg, Zydus Lifesciences said in a regulatory filing. Sacubitril and Valsartan combination is used to treat chronic heart failure in adults to help reduce the risk of death and hospitalisation. The drug will be manufactured at the group's formulation manufacturing facility in Moraiya, Ahmedabad, the company added.

Alembic Pharma receives USFDA nod for Bromfenac Ophthalmic Solution

The drug is expected to be manufactured in Alembic's manufacturing facilities in Gujarat, according to sources close to the company

Dr Reddy's, Sun Pharma recall drugs in US due to production issues: USFDA

Dr Reddy's Laboratories and Sun Pharma are recalling products in the US due to manufacturing issues, as per the latest Enforcement Report by the US Food and Drug Administration (USFDA). According to the report, Dr Reddy's Laboratories is recalling drugs to treat insomnia and gout in the American market. New Jersey-based Dr Reddy's Laboratories, Inc., a unit of Hyderabad-based drug major, is recalling 13,752 bottles of Eszopiclone tablets, the USFDA stated. The affected lot has been produced at Dr Reddy's Bachupally plant in Telangana. As per the USFDA, the drug firm is recalling the affected lot due to "Failed Impurities/Degradation Specifications". The company issued the Class III nationwide recall on June 4 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 consequences". Dr Reddy's Laboratories, Inc. is also recalling 20,520 units of Allopurinol tablets in the

USFDA pulls up Sun Pharma for manufacturing issues at Dadra facility

Sun Pharma failed to adequately clean and maintain equipment used for drug manufacturing at its Dadra-based manufacturing plant, as per the US Food and Drug Administration (USFDA). In a warning letter issued to company's Managing Director Dilip Shanghvi on June 18, the US health regulator stated it inspected the plant in the Union Territory of Dadra and Nagar Haveli and Daman and Diu from December 4-15, 2023. "Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitise and/or sterilise equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements," the USFDA said. The warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals at the facility, it stated. USFDA further noted that the company's investigations

USFDA approves second Alzheimer's drug that can modestly slow disease

U.S. officials have approved another Alzheimer's drug that can modestly slow the disease, providing a new option for patients in the early stages of the incurable, memory-destroying ailment. The Food and Drug Administration approved Eli Lilly's Kisunla on Tuesday for mild or early cases of dementia caused by Alzheimer's. It's only the second drug that's been convincingly shown to delay cognitive decline in patients, following last year's approval of a similar drug from Japanese drugmaker Eisai. The delay seen with both drugs amounts to a matter of months about seven months, in the case of Lilly's drug. Patients and their families will have to weigh that benefit against the downsides, including regular IV infusions and potentially dangerous side effects like brain swelling. Physicians who treat Alzheimer's say the approval is an important step after decades of failed experimental treatments. I'm thrilled to have different options to help my patients, said Dr. Suzanne Schindler, a .

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