Page 13 - Usfda

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.

Zydus Lifesciences gets US health regulator's nod for its generic medicine

Zydus Lifesciences Ltd on Friday said it has received final approval from the US health regulator for its generic doxepin hydrochloride capsules used in the treatment of depression and anxiety. The approval granted by the US Food and Drug Administration (USFDA) is for doxepin hydrochloride capsules of strength 150 mg, the company said in a regulatory filing. The drug will be manufactured at the group's formulation manufacturing facility in Moraiya, Ahmedabad, it added. Doxepin hydrochloride capsule is indicated to treat mental/mood problems such as depression and anxiety. It helps improve moods and feelings of well-being, relieves anxiety and tension, helps sleep better and increases the energy level, it added. The drug had annual sales of USD 2.11 million in the US, the company said citing IQVIA MAT January 2023 data.

Glenmark gets USFDA nod for generic drug with 180-day exclusivity

Glenmark Pharmaceuticals on Thursday said it has received an approval from the US health regulator to market a generic medication to treat plaque psoriasis. The company has received final approval from the US Food & Drug Administration (USFDA) for Calcipotriene and Betamethasone Dipropionate Foam, the generic version of Leo Pharma's Enstilar, Glenmark Pharma said in a statement. The USFDA noted that the Mumbai-based drug firm was the first abbreviated new drug application (ANDA) applicant with a paragraph IV certification for Calcipotriene and Betamethasone Dipropionate Foam, it added. "Therefore, with this approval, Glenmark is eligible for 180 days of generic drug exclusivity for Calcipotriene and Betamethasone Dipropionate Foam," the drug firm said. According to IQVIA sales data for the 12-month period ended January 2023, Enstilar Foam (0.005 per cent/0.064 per cent) achieved annual sales of around USD 93.6 million. Shares of the company were trading 0.49 per cent down at Rs ..

Glenmark gets USFDA nod to market generic medication to treat schizophrenia

Glenmark Pharmaceuticals on Monday said it has received approval from the US health regulator to market a generic product used to treat schizophrenia and in some cases to control severe nausea. The company has received nod from the US Food & Drug Administration (USFDA) for Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg, the Mumbai-based drug maker said in a statement. The company's product is the generic version of GlaxoSmithKline's Compazine tablets, it added. According to IQVIA sales data for the 12-month period ending January 2023, the Compazine tablets 5 mg and 10 mg achieved annual sales of around USD 26.9 million. Glenmark said its current portfolio consists of 182 products authorised for distribution in the US marketplace and 46 ANDAs (Abbreviated New Drug Applications) pending approval with the USFDA. PTI MSS.

Glenmark Pharma get USFDA nod for human trial of cancer-treating drug

Glenmark Pharmaceuticals on Thursday said its arm has received acceptance from the US health regulator to proceed with a phase 1/2, first-in-human trial for its investigational new drug aimed for treatment of patients with advanced cancers. In a regulatory filing, the company said Glenmark Specialty SA received the acceptance from the US Food and Drug Administration (USFDA) for the investigational new drug (IND) application 'GRC 54276' for the treatment of patients with advanced solid tumours and lymphomas. Developed by Glenmark, GRC 54276 is an orally available, small molecule hematopoietic progenitor kinase 1 (HPK1) inhibitor. HPK1-regulated functions are involved in nearly every step of the cancer-immunity cycle, making it an attractive target for immuno-oncology, the company said. By inhibiting HPK1, GRC 54276 is designed to potentially enhance the patient's own immune system to fight cancers, it added. "Now that the (US)FDA has accepted our IND application, we look forward to