Page 12 - Usfda

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

USFDA puts on hold Sun Pharma trials on dermatological drug regimen

The US health regulator has directed Sun Pharma to stop trials of a dermatological drug with a 12 mg dose regimen as its usage could lead to blood clots. The drug major on Tuesday said it had a teleconference call with the US Food and Drug Administration (USFDA) regarding a pulmonary embolism (serious adverse events) occurring at the 12 mg dose in one of the long-term Open Label Extension (OLE) studies. As a result, the agency has placed the investigational new drug (IND) on partial clinical hold due to the potential for thrombotic events and is requiring that subjects currently on the 12 mg dose in the OLE studies discontinue that dose, it added. There have been no thrombotic events reported to date for the 8 mg dose and USFDA has not placed the 8 mg dose on hold, the drugmaker said in a regulatory filing. "We are taking immediate steps to transition the patients in the OLE studies to the 8 mg BID dose arm in the ongoing studies," Sun Pharmaceutical Industries stated. No ...

USFDA puts partial clinical hold on Sun Pharma's dermatological drug

USFDA put a partial clinical hold on its application for an experimental dermatological drug due to the potential of thrombotic events

Pharma firm Ipca Labs' plant gets 3 observations from US drugs regulator

The observations were followed by the USFDA inspection at the site from April 18 to April 26

Zydus Lifesciences gets nod from USFDA for metronidazole topical cream

The drug will be manufactured at the group's topical manufacturing facility at Changodar, Ahmedabad

Zydus Lifesciences gets USFDA nod to its generic medicine for high BP

Zydus Lifesciences Ltd on Thursday said it has received final approval from the US health regulator to manufacture and market its generic version of metoprolol tartrate tablets used to treat high blood pressure. The approval granted by the United States Food and Drug Administration (USFDA) is for metoprolol tartrate tablets of strengths 25 mg, 50 mg, and 100 mg, Zydus Lifesciences said in a regulatory filing. The drug will be manufactured at the group's formulation manufacturing facility at Baddi in Himachal Pradesh, it added. Metoprolol is used with or without other medications to treat high blood pressure (hypertension), the company said, adding the medication is also used to treat chest pain (angina) and to improve survival after a heart attack. Metoprolol tartrate tablets 25 mg, 50 mg, and 100 mg had annual sales of USD 45.2 million in the US, the company said citing IQVIA MAT February 2023 data.

Zydus Lifesciences gets USFDA nod for generic female hormone in US market

Zydus Lifesciences on Tuesday said it has received approval from the US regulator to market a generic female hormone, which helps reduce symptoms of menopause, in the US market. The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Estradiol Transdermal System USP in the American market. Estradiol transdermal system is indicated for prevention of postmenopausal osteoporosis. The company said the drug will be manufactured at the group's formulation manufacturing facility in Moraiya, Ahmedabad in Gujarat. As per the IQVIA sales data, Estradiol Transdermal System had annual sales of USD 1.9 million in the US.

Global Pharma recalls 50,000 tubes of contaminated eye drops in US: USFDA

Global Pharma Healthcare is recalling 50,000 tubes of eye drops in the US market due to bacterial contamination, according to the US Food and Drug Administration (USFDA). As per its latest Enforcement Report, the US health regulator noted that the Chennai-based drug firm is recalling the affected lot of eye lubricant for artificial tears which have been linked to vision loss in the US. The lot has been manufactured by Chennai-based Global Pharma Healthcare and distributed in the US market by New York-based Delsam Pharma, the USFDA said. Stating the reason for recall, the US health regulator said: "FDA analysis found unopened tubes to be contaminated with bacteria." The company initiated the Class I recall on February 24 this year. As per the USFDA, a Class I recall is the most urgent of the three types of FDA recalls and usually pertains to defective products that can cause serious health problems. In February, Global Pharma Healthcare had announced that it is recalling its entir

USFDA issues Form-483 with 10 observations to Lupin's Pithampur plant

Drug firm Lupin on Thursday said the US health regulator has issued a Form-483 with ten observations after inspecting its Pithampur Unit-2 manufacturing facility. The US Food and Drug Administration (USFDA) inspected the plant from March 21 to March 29, 2023. The inspection closed with issuance of a Form-483 with ten observations, Lupin said in a regulatory filing. "We are addressing the observations comprehensively and will work with the US FDA to resolve these issues at the earliest," it added. As per the USFDA, a 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 judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. In November last year, USFDA had issued Form-483 with eight observations each for product and raw material production centres at Lupin's Mandideep-based manufacturing facility. In October 2022, the drugmaker announced that the US health .

Lupin gets tentative USFDA approval to market generic valbenazine capsules

Pharmaceuticals firm Lupin Ltd on Monday said it has received tentative approval from the US health regulator to market its generic valbenazine capsules used to treat involuntary movements of the face, tongue or other body parts. The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of valbenazine capsules of strengths 40 mg, 60 mg and 80 mg, the company said in a regulatory filing. These are the generic equivalent of Ingrezza capsules, 40 mg, 60 mg, and 80 mg, of Neurocrine Biosciences, Inc, it added. Valbenazine capsules had estimated annual sales of USD 1,235 million in the US, the company said, citing IQVIA MAT December 2022 data.