Page 10 - Usfda

Zydus Lifesciences gets final FDA nod for Darunavir for HIV-1 treatment

According to market research firm IQVIA, Darunavir Tablets, 75 mg, 150 mg, 600 mg, and 800 mg had annual sales of $275 million in the US

Granules India gets USFDA nod for generic pantoprazole sodium tablets

Granules India Ltd on Wednesday said it has received approval from the US health regulator for its generic pantoprazole sodium delayed-release tablets used in the short-term treatment of erosive esophagitis associated with gastroesophageal reflux disease. The approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for pantoprazole sodium delayed-release tablets of strengths 20 mg and 40 mg, Granules India said in a regulatory filing. It is bioequivalent and therapeutically equivalent to the reference listed drug, Protonix Delayed-Release Tablets, 20 mg and 40 mg strengths, of Wyeth Pharmaceuticals LLC, it added. Pantoprazole sodium delayed-release tablets are indicated for short-term treatment of erosive esophagitis associated with gastroesophageal reflux disease (GERD) -- a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus. The medicine is also used for the maintenance ..

USFDA issues Form 483 with 5 observations to Torrent Pharma's Guj unit

Torrent Pharmaceuticals Ltd on Tuesday said the US health regulator has issued Form 483 with five procedural observations after inspecting its oral manufacturing facility situated at Bileshwarpura in Gujarat. As per the 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. The USFDA conducted a pre-approval Inspection at the company's oral manufacturing facility situated in Bileshwarpura, Gujarat from December 5 to 11, 2023, Torrent Pharma said in a regulatory filing. "At the end of the inspection, the company was issued a Form 483 with five procedural observations. There was no observation related to data integrity reported,"it added. The company also said, "we will respond to the USFDA within the prescribed time frame and will work in close collaboration with the agency to ...

USFDA pulls up Intas Pharma for manufacturing lapses at Ahmedabad plant

The US health regulator has pulled up Intas Pharmaceuticals for manufacturing lapses, including violation of current good manufacturing practice (CGMP) regulation, at its Ahmedabad-based plant. In a warning letter to the company's CEO and MD Nimish Chudgar, the US Food and Drug Administration (USFDA) has pointed out various manufacturing lapses at the Matoda-Sanand, Ahmedabad-based facility. A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations. The USFDA inspected the facility from May 1-12, 2023. "This warning letter summarises significant violations of CGMP regulations for finished pharmaceuticals... Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated," it noted. In the warning letter, the health regulator pointed out the company "failed to exercise its responsibility to ensure drug products manufactured

Sun Pharma subsidiary announces licensing pact with Aclaris Therapeutics

Aclaris Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel drugs for immuno-inflammatory diseases

US regulators inspect Dr Reddy's, other Indian pharma majors: Report

Rivals Sun Pharma's Dadra facility and Torrent Pharmaceuticals Ltd's oncology unit are also undergoing FDA inspections

Zydus Lifesciences receives USFDA approval for Ivabradine tablets

On Friday, shares of Zydus Lifesciences were up/down by 0.34 per cent, ending the day's trade at Rs 640 apiece on the BSE

Aurobindo Pharma unit gets USFDA nod to market generic asthma medication

Aurobindo Pharma on Thursday said its subsidiary has received approval from the US health regulator to market a generic medication to treat asthma in children. Eugia Pharma Specialities, a wholly-owned subsidiary of the company, has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Budesonide Inhalation Suspension, the Hyderabad-based drug firm said in a regulatory filing. The company's product is therapeutically equivalent to Astrazeneca Pharmaceuticals LP's Pulmicort Repsules Inhalation Suspension, it added. The product, indicated for treatment of asthma and as prophylactic therapy in children of age 12 months to 8 years, is expected to be launched in FY25, Aurobindo Pharma said. As per IQVIA data, the approved product has an estimated market size of USD 226.4 million for the 12 months ended September 2023. Shares of Aurobindo Pharma were trading 1.51 per cent up at 1,036.55 apiece on the BSE.

Aurobindo Pharma receives USFDA approval to manufacture Darunavir tablets

Darunavir Tablets, 600 mg, and 800 mg, in combination with other antiretroviral agents, are indicated for the treatment of (HIV-1) infection in adult and pediatric patients 3 years of age and older

Strides Pharma gets USFDA approval for Levetiracetam Oral Solution

The Levetiracetam Oral Solution has a market size of around $55 million, according to data reported by IQVIA

Cipla's Pithampur unit gets USFDA warning; analysts remain bullish

On Monday, Cipla share price dropped 0.21 per cent, ending the day's trade at Rs 1,246 apiece on the BSE

Dr Reddy's launches wearable device for drug-free management of migraine

In January this year, Dr Reddy's entered an exclusive agreement with Theranica for the marketing and distribution of Nerivio in India

US approves 1st vaccine against chikungunya virus: All you need to know

Symptoms of chikungunya can sometimes last for months or even years, but the virus is rarely fatal

Glenmark Pharmaceuticals receives USFDA approval for generic Prolixin

Prolixin is a prescription medication used to treat schizophrenia and other mental/mood disorders

USFDA approves new version of diabetes drug Mounjaro for weight loss

A new version of the popular diabetes treatment Mounjaro can be sold as a weight-loss drug, US regulators announced on Wednesday. The US Food and Drug Administration approved Eli Lilly's Zepbound, or tirzepatide. The drug helped dieters lose about a quarter of their body weight, or 60 pounds (27 kilograms), in a recent study. Zepbound is the latest diabetes drug approved for weight loss, joining Novo Nordisk's Wegovy, a high-dose version of its diabetes treatment Ozempic. The FDA approved Lilly's drug for people who are considered obese, with a body mass index of 30 or higher, or those who are overweight with a related health condition, like high blood pressure, high cholesterol or diabetes. The drug should be paired with a healthy diet and regular exercise, the FDA said. In the US, at least 100 million adults and about 15 million children are considered obese. The drug tirzepatide in Zepbound and Mounjaro and semaglutide in Wegovy and Ozempic work by mimicking hormones that kick

Lupin receives approval from the US FDA for its Selexipag for injection

In 2022, sales of the Selexipag Franchise in the US stood at $ 1.1 billion. The sales for January 1 to September 30, 2023, stood at $978 million

Granules India gets USFDA nod for generic drug used to treat heartburn

Granules India Ltd on Thursday said it has received approval from the US health regulator for its generic Esomeprazole Magnesium delayed-release capsules indicated for short-term treatment of heartburn and other symptoms associated with gastroesophageal reflux disease. The approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for Esomeprazole Magnesium delayed-release capsules of strengths 20 mg and 40 mg, Granules India said in a regulatory filing. It is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Nexium Delayed-Release Capsules, 20 mg and 40 mg, of AstraZeneca Pharmaceuticals LP. Esomeprazole Magnesium capsules are indicated for short-term treatment of heartburn and other symptoms associated GERD, risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults and long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison ...

Zydus unit recalls 7,248 bottles of Oxybutynin Chloride tablets in US

A unit of Zydus Lifesciences is recalling over 7,000 bottles of Oxybutynin Chloride tablets in the US due to manufacturing issues, according to the US Food and Drug Administration (USFDA). As per its latest Enforcement Report, the US health regulator said the drugmaker is recalling 7,248 bottles of Oxybutynin Chloride extended-release tablets, used to treat overactive bladder and urinary conditions, in the US. New Jersey-based Zydus Pharmaceuticals (USA) Inc. is recalling the affected lot due to "Failed Dissolution Specifications", the USFDA stated. The lot was produced at Ahmedabad and distributed in the US by Zydus Pharmaceuticals (USA) Inc, the US health regulator stated. The drug firm initiated the Class II recall on September 21 this year. As per the USFDA, a Class II recall is initiated in a situation in which the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse hea

Lupin receives tentative approval from US FDA for apalutamide tablets

Lupin develops and commercialises a wide range of branded and generic formulations, biotechnology products, and Active Pharmaceutical Ingredients (APIs) in over 100 markets

USFDA rejects proposed Biocon's Insulin Aspart application in CRL

Biotechnology major Biocon on Saturday said the US health regulator has issued a complete response letter for Biocon Biologics' application for Insulin Aspart, a proposed biosimilar for diabetes treatment. The US Food and Drug Administration (USFDA) has issued a Complete Response Letter (CRL) to convey to the company that its initial review of an application is complete, and it cannot approve the application in its present form. "The CRL did not identify any outstanding scientific issues with the product. The CRL references the requirement for a satisfactory resolution of deficiencies from the pre-approval inspection (PAI) of our Malaysia facility for Insulin Aspart, held in August 2022," Biocon spokesperson said in a regulatory filing. The company had submitted a comprehensive Corrective and Preventive Action (CAPA) plan in September 2022 that the agency found to be adequate and indicated that it would require a re-inspection of the Malaysia facility prior to the approval of the ..