Page 12 - Usfda

Glenmark Pharmaceuticals gets USFDA nod to market generic diabetes drug

Glenmark Pharmaceuticals on Tuesday said it has received approval from the US health regulator to market a generic diabetes drug in the American market. The company has received final approval from the US Food & Drug Administration (US FDA) for Saxagliptin Tablets (2.5 mg and 5 mg), the generic version of AstraZeneca's Onglyza1 tablets, the Mumbai-based drug maker said in a statement. According to IQVIATM sales data, for the 12-month period ending June 2023, the Onglyza tablets (2.5 mg and 5 mg) achieved annual sales of around USD 100.7 million. Glenmark said its current portfolio now consists of 184 products authorized for distribution in the US market and 49 abbreviated new drug applications (ANDAs) are pending approval with the US FDA.

Tornado damage to Pfizer plant unlikely to cause supply shortages: US FDA

Most of the destruction from a tornado that tore through eastern North Carolina on Wednesday and struck a large Pfizer pharmaceutical plant affected its storage facility, rather than its medicine production areas, the company said on Friday. The drugmaker's ability to salvage production equipment and other essential materials could mitigate what experts feared would be a major blow to an already strained system as the United States grapples with existing drug shortages. We do not expect there to be any immediate significant impacts on supply given the products are currently at hospitals and in the distribution system, US Food and Drug Administration Commissioner Robert Califf said on Friday. An EF3 tornado touched down on Wednesday near Rocky Mount, ripping the roof off a Pfizer factory responsible for producing nearly 25 per cent of the American pharmaceutical giant's sterile injectable medicines used in US hospitals, according to the drugmaker. Pfizer said on Friday that a wareho

Dr Reddy's application for biosimilar candidate accepted for USFDA's review

Dr Reddy's Laboratories on Wednesday said its biologics licence application for its proposed biosimilar rituximab candidate has been accepted for a substantive review by the US Food and Drug Administration (USFDA). This closely follows acceptance of the rituximab biosimilar dossier for review by two other regulatory agencies -- the European Medicines Agency (EMA) and the UK's Medicines and Healthcare products Regulatory Agency (MHRA). Rituximab is used to treat certain autoimmune diseases and types of cancer. "This milestone underscores our capability for global clinical development of high-quality biosimilar products for highly regulated and global markets," Dr Reddy's Global Head of Biologics Jayanth Sridhar said in a statement. It also reinforces the potential of the product as a safe and effective treatment option for patients across the globe, he added. Development and commercialisation of biological drugs is an important growth lever for the company's business, Sridhar ...

Lupin gets USFDA establishment inspection report for Pithampur facility

Drug firm Lupin on Tuesday said it has received an Establishment Inspection Report from the US health regulator for its Pithampur Unit-2 manufacturing facility. The Establishment Inspection Report (EIR) was issued after the last inspection of the facility, which manufactures oral solids and ophthalmic dosage forms, conducted from March 21-29, 2023, the Mumbai-based drug maker said in a statement. The US Food and Drug Administration (FDA) issues an EIR on closure of inspection of an establishment that is the subject of an FDA or FDA-contracted scrutiny. The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI). According to the the USFDA, a VAI means that objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. "This is a significant milestone as we build back our reputation of being best-in-class in quality and compliance. We look forward to ne

Lupin gets USFDA approval for generic version of Cyanocobalamin nasal spray

Pharma major Lupin Ltd on Monday said it has received approval from the US health regulator for its generic version of Cyanocobalamin nasal spray. The approval granted by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Cyanocobalamin nasal spray of strength 500 mcg/spray (one spray per device), Lupin said in a statement. Cyanocobalamin nasal spray is used to maintain normal vitamin B12 blood levels in patients with pernicious anaemia. "This product will be manufactured at Lupin's Somerset facility in the US," the company added. Cyanocobalamin nasal spray had estimated annual sales of USD 69 million in the US, Lupin said, citing IQVIA MAT March 2023 data.

Lupin receives US regulator's approval for Cyanocobalamin nasal spray

The nasal spray manufactured by Lupin is a generic version of Nascobal nasal spray

USFDA observations in 2022 focus on ancillary infra, written procedures

45% observations in 2022 around unavailability of written procedures and facility maintenance, ancillary infrastructure

Facing higher scrutiny, IPA plans monthly meetings with members on quality

Data suggests that Indian sites received fewer OAIs in the first six months of 2023

USFDA emphasises on response over perfection in inspections: Sarah McMullen

McMullen stressed the importance of a robust quality system

Spiriva approval gives earnings visibility to Lupin; valuations expensive

Lupin's shares declined 4.5 per cent in Thursday's intra-day trade

Fewer Indian pharma plants get US FDA action notice in 2023, so far

6 per cent of inspections in first 6 months of CY23 resulted in OAI status

Zydus Lifesciences gets USFDA nod for generic acne-treating drug

Zydus Lifesciences on Monday said it has received final approval from the US health regulator for its generic antibiotic Minocycline Hydrochloride extended-release tablets used for treatment of moderate to severe acne. The approval granted by the US Food and Drug Administration (USFDA) is for Minocycline Hydrochloride extended-release tablets of strengths 55 mg, 65 mg, and 115 mg, Zydus Lifesciences said in a regulatory filing. The tablet is used for treatment of moderate to severe acne in people aged 12 years and above. The product will be manufactured at the group's formulation manufacturing facility in Moraiya, Ahmedabad, the company said.

Pharma major Lupin gets establishment inspection report from USFDA

Lupin Limited received an inspection classification of "No Action Indicated" (NAI) after the inspection, which was conducted between March 6 to March 10

Ipca shares drop nearly 3% after USFDA's 11 observations about MP facility

Company says it takes quality and compliance issues with 'utmost importance'

Zydus Lifesciences gets USFDA nod to mfg generic version of Varenicline

Zydus Lifesciences on Tuesday said it has received final approval from the US health regulator to manufacture and market the generic version of Varenicline tablets indicated to treat smoking addiction. The approval by the US Food and Drug Administration (USFDA) is for Varenicline tablets of strengths 0.5 mg and 1 mg, Zydus said in a regulatory filing. The product will be launched shortly. It will be manufactured at the group's formulation manufacturing facility at Ahmedabad SEZ, India, it added. Varenicline tablets, 0.5 mg and 1 mg had annual sales of USD 501 million in the US, the company said citing IQVIA MAT March 2023 data.

Zydus receives final approval from USFDA for esomeprazole magnesium

Esomeprazole magnesium for delayed-release oral suspension, 20 mg and 40 mg had annual sales of $42 mn in the United States

US FDA to temporarily import Chinese cancer drug to ease shortage

Cisplatin, a generic drug available for decades in the US, has faced national shortage since February after an Indian pharmaceutical company temporarily halted production for the US market

USFDA inspections of Indian sites still below pre-Covid-19 levels

On an average Indian sites have had only a 9% share of total global inspections, analysts point out

Contaminated drugs: USFDA uncovers failures in India's pharma factories

The $50 billion sector is under the spotlight after a number of recent scandals linked to smaller, privately-held Indian companies, including the deaths of dozens of children in Gambia and Uzbekistan

Caplin Point rises 10% after arm gets USFDA nod for anti-inflammatory drug

So far this calendar year (CY23), shares of Caplin Point have declined 0.4 per cent, as against 1 per cent rise in the S&P BSE Sensex