Page 10 - Usfda

USFDA nod to Lupin for generic Loteprednol Etabonate ophthalmic suspension

Pharma major Lupin Ltd on Wednesday said it has received approval from the US health regulator to market its generic Loteprednol Etabonate ophthalmic suspension indicated for temporary relief of seasonal allergic conjunctivitis. The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Loteprednol Etabonate ophthalmic suspension, 0.2 per cent, Lupin said in a regulatory filing. It is a generic equivalent to the reference listed drug (RLD) Alrex ophthalmic suspension, 0.2 per cent of Bausch & Lomb Inc. The product will be manufactured at Lupin's Pithampur facility in India, the company added. Loteprednol Etabonate ophthalmic suspension, 0.2 per cent, is indicated for the temporary relief of signs and symptoms of seasonal allergic conjunctivitis. It had estimated annual sales of USD 29.1 million in the US market, Lupin said citing IQVIA MAT October 2023 data.

Aurobindo Pharma gets USFDA approval for generic antifungal injection

Aurobindo Pharma Ltd on Wednesday said its wholly-owned arm Eugia Pharma Specialities Ltd has received final approval from the US health regulator to manufacture and market generic Posaconazole injection used to prevent serious fungal infections. The approval by the US Food & Drug Administration (USFDA) is for Posaconazole injection of 300 mg/16.7 mL (18 mg/mL), single-dose vial, Aurobindo Pharma said in a regulatory filing. It is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Noxafil Injection, 300 mg/16.7 mL (18 mg/mL), of Merck Sharp & Dohme LLC (Merck), it added. "The product is expected to be launched in December 2023," the company said. Posaconazole injection, 300 mg/16.7 mL (18 mg/mL), single-dose vial is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised due to certain conditions, it added. The approved ...

Aurobindo Pharma gets 'Voluntary Action Indicated' classing from US FDA

The classification follows an inspection conducted by the FDA from September 13 to September 19, 2023

Sun Pharma, Lupin recall drugs in US market over manufacturing issues: FDA

Leading drugmakers Sun Pharma and Lupin are recalling products in the US market over manufacturing issues, as per the US Food and Drug Administration (USFDA). Mumbai-based Sun Pharmaceutical Industries is recalling 96,192 bottles of Liothyronine Sodium Tablets in the US that are used to treat an underactive thyroid, according to the latest enforcement report issued by the American health regulator. Princeton-based Sun Pharmaceutical Industries Inc, a unit of the company, is recalling the affected lot that was produced at the drugmaker's Dadra-based facility. The company is recalling the lot due to "failed impurities/degradation specifications", the USFDA stated. The company commenced the voluntary nationwide Class II recall on December 4, this year. USFDA stated that Mumbai-based Lupin is also recalling an unspecified number of penicillamine tablets in the US. The medication is used to treat rheumatoid arthritis and Wilson's disease. Baltimore-based Lupin Pharmaceuticals Inc, a u

Zydus Lifesciences gets USFDA nod to sell generic anti-epileptic medication

Zydus Lifesciences on Saturday said it has received approval from the US health regulator to market a generic anti-epileptic medication. The company has received approval from the US Food and Drug Administration (USFDA) to manufacture and market Lacosamide Tablets in multiple strengths, the drug firm said in a statement. Lacosamide is indicated to treat partial-onset seizures. It is also used with other medicines to treat primary generalized tonic-clonic seizures. The company said it will manufacture the product at the group's formulation manufacturing facility in Moraiya, Ahmedabad. As per IQVIA data, Lacosamide Tablets had annual sales of USD 249 million in the US.

Indian companies likely to garner up to 50% USFDA nod share in 2023

Companies may get up to 375 ANDA approvals in 2023, more than last year's 355

Zydus gets USFDA's approval for antiviral drug used in HIV treatment

Zydus Lifesciences on Friday said it has received approval from the US health regulator to market a generic antiviral medication used in the treatment of HIV-1 infection. The company has received final approval from the US Food and Drug Administration (USFDA) for Darunavir Tablets, the company said in a statement. Darunavir is a protease inhibitor antiviral medicine that prevents Human Immunodeficiency Virus (HIV-1) from multiplying in the body. It is indicated for the treatment of HIV-1 infection in adult patients. It is also indicated for the treatment of HIV-1 infection in pediatric patients three years of age and older. It must be co-administered with Ritonavir and with other antiretroviral agents. Zydus said the product will be manufactured at the group's formulation manufacturing facility in SEZ, Ahmedabad, Gujarat. As per IQVIA MAT data, Darunavir tablets (75 mg, 150 mg, 600 mg, and 800 mg) had annual sales of USD 275 million in the US. Shares of the company were trading

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