Usfda

Granules India gets US regulator FDA's approval for generic ADHD drug

Drug firm Granules India on Tuesday said its subsidiary has received approval from the US health regulator for a generic medication used to treat attention-deficit hyperactivity disorder. Granules Pharmaceuticals, Inc (GPI) has received approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Lisdexamfetamine Dimesylate chewable tablets, the drug firm said in a statement. The approved drug is available in multiple strengths; 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg, it added. The company's product is the generic equivalent to Takeda Pharmaceuticals' Vyvanse chewable tablets, the company said. The medication is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients aged six years and older, as well as moderate to severe binge eating disorder (BED) in adults. Lisdexamfetamine dimesylate chewable tablets are currently published on the FDA Drug Shortages List, emphasising ..

Aurobindo Pharma, Glenmark, and Zydus recall products in US over mfg issues

Drug makers Aurobindo Pharma, Glenmark and Zydus are recalling products in the US market due to manufacturing issues, according to the US health regulator. As per the latest Enforcement Report of US Food and Drug Administration (USFDA), Aurobindo Pharma USA Inc, a subsidiary of Hyderabad-based drug maker, is recalling over 1 lakh bottles of Cinacalcet tablets in multiple strengths. The New Jersey-based firm is recalling the product due to "GMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit," the US health regulator said. The company initiated the Class II recall on November 7 this year. Cinacalcet tablets are used to treat hyperparathyroidism. Similarly, a US-based subsidiary of Glenmark Pharmaceuticals is recalling around 90,000 bottles of Diltiazem Hydrochloride extended-release capsules (multiple strengths) in the US market. New Jersey-based Glenmark Pharmaceuticals Inc, USA is recalling the affected lot of Diltiazem Hydrochloride ...

Bajaj Healthcare rises 6% as Gujarat API site gets nod from TGA, Australia

The mentioned site has already received approval from the US FDA (US Food and Drug Administration) and EU, as per the filing

Biocon share falls 4% after USFDA issues VAI tag for Bengaluru's API unit

Biocon's Bengaluru API facility was inspected between September 23 to September 27, 2024

USFDA approves Biocon Biologics' biosimilar for Crohn's disease, psoriasis

YESINTEK, a monoclonal antibody, is approved for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis

Lupin recalls over 600,000 bottles of hypertension drug in US: USFDA

Drug firm Lupin is recalling over six lakh bottles of a medication indicated for high blood pressure in the US due to deviation from current good manufacturing practices (CGMP), according to the US health regulator. As per its latest Enforcement Report, US Food and Drug Administration (USFDA), stated that Dr Reddy's Laboratoties is also recalling a product in the US due to a manufacturing issue. Baltimore-based Lupin Pharmaceuticals Inc, a subsidiary of Mumbai-based Lupin, is recalling 6,16,506 bottles of Ramipril capsules in strengths of 2.5 mg, 5 mg and 10 mg, the US health regulator said. The affected lot is manufactured at Lupin's Goa-based manufacturing facility, it stated. The company is recalling 1,12,770 bottles of 2.5 mg tablets; 1,46,322 bottles of 5 mg tablets and 3,57,414 bottles of 10 mg tablets, it said. The US health regulator noted that the company is undertaking Class II voluntary recall due to "CGMP Deviations: Active pharmaceutical ingredient was sourced from an

USFDA issues seven observations to Dr Reddy's Hyderabad manufacturing plant

Dr Reddy's Laboratories Ltd on Tuesday said the US health regulator has issued a Form 483 with seven observations to its active pharmaceutical ingredient manufacturing facility in Bollaram, Hyderabad. "The US Food & Drug Administration (USFDA) today completed a GMP inspection at our API manufacturing facility (CTO-2) in Bollaram, Hyderabad," Dr Reddy's Laboratories Ltd (DRL) said in a regulatory filing. The inspection was conducted from November 13-19, 2024, it added. "We have been issued a Form 483 with seven observations, which we will address within the stipulated timeline," the company said. As per 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.

Drug maker Cipla gets 8 observations from USFDA for Bengaluru facility

Drug maker Cipla on Wednesday said the US health regulator has issued eight observations after inspecting its Bengaluru-based plant. The US Food and Drugs Administration (USFDA) conducted an inspection at the company's manufacturing facility in Virgonagar, Bengaluru from November 7- 13, the Mumbai-based based drug maker said in a filing to BSE. On conclusion of the inspection, the company received eight observations in Form 483, it added. The company said it will work closely with the USFDA and remain committed to addressing these observations comprehensively within stipulated time.

Alembic Pharmaceuticals gets USFDA nod for hypertension treatment capsules

Alembic Pharmaceuticals Ltd on Monday said it has received final approval from the US health regulator for its generic Diltiazem Hydrochloride extended-release capsules indicated for the treatment of hypertension. The approval by the US Food & Drug Administration (USFDA) for the abbreviated new drug application (ANDA) for Diltiazem Hydrochloride Extended-Release Capsules of strengths 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg, Alembic Pharmaceuticals Ltd (Alembic) said in a statement. These capsules are indicated for the treatment of hypertension. These capsules may be used alone or in combination with other antihypertensive medications. Moreover, Diltiazem Hydrochloride is also indicated for the management of chronic stable angina and angina due to coronary artery spasm, the company said. Diltiazem Hydrochloride extended-release capsules 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg have an estimated market size of USD 105.3 million for the 12 months ended June 2024, the company ...

McDonald's E coli case count rises as officials inspect onion grower

Federal officials have reported more cases of E. coli poisoning among people who ate at McDonald's, as government investigators seeking the outbreak's source identified an onion grower of interest in Washington state. The Food and Drug Administration said 90 people across 13 states have fallen ill in the outbreak, up from 75 at the end of last week. The number of people hospitalised increased by five, to 27 people. One death has been tied to the outbreak. Officials have said raw, slivered onions on McDonald's Quarter Pounder hamburgers are the likely source of the E. coli. McDonald's said the onions came from a single supplier, the California-based Taylor Farms. The company has since recalled the yellow onions it sent to McDonald's and other restaurant chains. The FDA said Wednesday it has begun inspecting Taylor Farm's processing centre in Colorado Springs as well as an onion grower of interest in Washington state. It did not name the grower. More than 80 per cent of people with E

Zydus Lifesciences gets USFDA nod for generic schizophrenia treatment drug

Zydus Lifesciences Ltd on Thursday said it has received final approval from the US health regulator to manufacture its generic version of Paliperidone extended-release tablets, used to treat schizophrenia. The approval by the US Food and Drug Administration (USFDA) is for Paliperidone extended-release tablets of strengths 1.5 mg, 3 mg, 6 mg, and 9 mg, Zydus Lifesciences said in a regulatory filing. These tablets will be produced at the group's manufacturing site at SEZ, Ahmedabad, it added. Paliperidone extended-release tablets are indicated for the acute and maintenance treatment of schizophrenia, acute treatment of schizoaffective disorder as monotherapy and acute treatment of schizoaffective disorder as an adjunct to mood stabilisers and/or antidepressants, the company said.

US FDA grants fast track status to Wockhardt's novel antibiotic WCK 6777

WCK 6777 is a once-a-day, β-lactam enhancer used for outpatient parenteral antimicrobial therapy

Eli Lilly's blockbuster weight-loss drug no longer in shortage in US: USFDA

The shortage of all doses of the drug, tirzepatide, sold as Mounjaro for diabetes and Zepbound for weight management has been resolved

Zydus Lifesciences receives USFDA approval to produce prostrate cancer drug

Zydus Lifesciences on Wednesday said it has received approval from the US health regulator to produce a generic prostate cancer treatment drug. The company has received tentative approval from the US Food and Drug Administration (USFDA) to manufacture Enzalutamide tablets (40 mg and 80 mg), the drug maker said in a regulatory filing. Enzalutamide tablets are androgen receptor inhibitors indicated for the treatment of patients with castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer. The product would be manufactured at the Group's manufacturing site at SEZ, Ahmedabad. As per IQVIA MAT July 2024 data, Enzalutamide tablets (40 mg and 80 mg) had annual sales of USD 1,417.2 million in the US. The Zydus group now has 400 approvals and has so far filed over 465 Abbreviated New Drug Application (ANDAs) since the commencement of the filing process in FY 2003-04, it said.

Aurobindo Pharma subsidiary gets 10 observations from USFDA for API plant

Aurobindo Pharma on Monday said the US health regulator has issued 10 observations after inspecting the API facility of its subsidiary in Telangana. The US Food and Drug Administration (USFDA) inspected Unit-II, an active pharmaceutical ingredients (API) manufacturing facility of Apitoria Pharma, a wholly-owned subsidiary of the company, in Sangareddy district from September 23-27, 2024, the Hyderabad-based drug maker said in a regulatory filing. The inspection closed with 10 observations, it added. The observations are procedural in nature and will be responded to within the stipulated time, the drug maker stated. Shares of Aurobindo Pharma on Monday ended 3.16 per cent down at Rs 1,462 apiece on BSE.

Aurobindo Pharma share down 4% as arm gets 10 observations from USFDA

Aurobindo Pharma's subsidiary Apitoria Pharma has received 10 observations from the USFDA for its API manufacturing facility in Telangana

Zydus gets USFDA approval to produce its generic prostate cancer drug

Zydus Lifesciences on Saturday said it has received approval from the US health regulator to produce generic prostate cancer treatment drug. The company has received approval from the US Food and Drug Administration (USFDA) to manufacture Enzalutamide capsules (40 mg), it said in a regulatory filing. Enzalutamide capsules are androgen receptor inhibitors indicated for the treatment of patients with metastatic castration-resistant prostate cancer. The drug will be produced at the group's manufacturing site in Moraiya, Ahmedabad, Zydus said. As per IQVIA MAT July 2024 data, Enzalutamide capsules (40 mg) had annual sales of USD 869.4 million in the US. The group now has 400 approvals and has filed over 465 abbreviated new drug applications (ANDAs) since the commencement of the filing process in FY 2003-04.

US FDA approves Bristol Myers' Squibb drug for treating schizophrenia

Bristol Myers obtained the drug Cobenfy, also known as KarXT, through its $14 billion takeover of Karuna Therapeutics last year

Eli Lilly wants records of people who took copies of its weight-loss drug

The Food and Drug Administration has listed an ongoing shortage of Lilly's medicines since December 2022

Strides Pharma Science gets USFDA nod for generic antidepressant tablets

Strides Pharma Science Ltd on Monday said its arm has received approval from the US health regulator for its generic version of antidepressant Fluoxetine tablets. The approval granted by the US Food & Drug Administration (USFDA) to wholly owned subsidiary Strides Pharma Global Pte. Ltd, Singapore, is for Fluoxetine tablets of strength 60 mg, Strides Pharma Science said in a regulatory filing. The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Fluoxetine tablets, 60 mg, of TWi Pharmaceuticals, Inc, it added. The Fluoxetine tablets will be manufactured at the company's facility in Puducherry, Strides said. With the approval of the Fluoxetine Tabs 60 mg strength, the company is now positioned to offer a complete portfolio of Fluoxetine across capsules and tablets in 10 mg, 20 mg, and 60 mg strengths, it added. The addition of the Fluoxetine tablets 60 mg will allow for enhanced flexibility in dosing, catering to a broader spectrum of ...