Page 9 - Usfda

US FDA approves Eyenovia's eye drops to reduce pain: Formosa Pharma

Eyenovia acquired US commercial rights of the drug last August from Formosa

Biocon Biologics signs agreement with Janssen Biotech for psoriasis drug

Biocon said that the U.S. FDA has accepted the Biologics License Application (BLA) for Bmab 1200 (bUstekinumab) for review under the 351(k) pathway

Zydus Lifesciences gets USFDA nod for generic drug to prevent chest pain

Zydus Lifesciences Ltd on Friday said it has received final approval from the US health regulator to manufacture and market its generic Isosorbide Mononitrate extended-release tablets used to prevent chest pain in patients with a certain heart condition. The approval by the US Food and Drug Administration (USFDA) is to manufacture and market Isosorbide Mononitrate Extended-Release, of strengths 30 mg, 60 mg, and 120 mg, Zydus Lifesciences said in a regulatory filing. Isosorbide mononitrate is used to prevent chest pain (angina) in patients with a certain heart condition, coronary artery disease, it added. The product will be manufactured at the group's formulation manufacturing facility at Ahmedabad SEZ, the company said. Isosorbide Mononitrate extended-release tablets 30 mg, 60 mg, and 120 mg had annual sales of USD 47 million in the US, Zydus said citing IQVIA December 2023 data. PTI RKL.

Lupin gets approval from USFDA for pregnancy prevention drug 'Minzoya'

Pharma major Lupin Ltd on Friday said it has received approval from the US health regulator to market its generic 'Minzoya' tablets used to prevent pregnancy. The approval granted by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Minzoya (Levonorgestrel and Ethinyl Estradiol tablets, and Ferrous Bisglycinate tablets) of strengths 0.1 mg/0.02 mg and 36.5 mg, Lupin said in a regulatory filing. The drug is a generic equivalent of Balcoltra (Levonorgestrel and Ethinyl Estradiol Tablets, USP and Ferrous Bisglycinate Tablets) 0.1 mg/0.02 mg and 36.5 mg, of Avion Pharmaceuticals LLC, it added. The product will be manufactured at Lupin's Pithampur facility in India, the company said. Minzoya tablets are indicated for use by females of reproductive potential to prevent pregnancy. Levonorgestrel and Ethinyl Estradiol tablets, and Ferrous Bisglycinate tablets had estimated annual sales of USD 42 million in the US, the company said citing IQVIA MAT

Dr Reddy's Laboratories R&D facility gets VAI status in USFDA inspection

Last year in December, during the Good Manufacturing Practice (GMP) and Pre-Approval Inspection at the same facility concluded with three observations

Biocon gets USFDA approval to market generic anti-cancer medication

Biocon Ltd on Tuesday said it has received approval from the US health regulator for a generic anti-cancer medication. The company has received approval from the US Food and Drug Administration (USFDA) for Dasatinib tablets to market in strengths of 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, Biocon said in a regulatory filing. The approval will further strengthen the company's portfolio of vertically integrated, complex drug products, it added. Shares of Biocon settled 4.97 per cent higher at Rs 298.75 apiece on the BSE.

Lupin secures a tentative USFDA approval for Rivaroxaban tablets

Lupin boasts 15 manufacturing sites, 7 research centres, and a global team of more than 20,000 professionals

USFDA finds new manufacturing lapses at pharma co Eli Lilly's plant: Report

Lilly said in a statement to Reuters that the inspection followed a company request to the FDA to make a change to its manufacture of migraine treatment Emgality

Lupin gets USFDA nod to market generic hyperuricemia treatment drug

Pharma major Lupin Ltd on Thursday said it has received approval from the US health regulator to market its generic Febuxostat tablets, indicated for the chronic management of hyperuricemia in adult patients with gout. The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Febuxostat tablets of strengths 40 mg and 80 mg, a generic equivalent of Uloric tablets, 40 mg and 80 mg, of Takeda Pharmaceuticals USA, Inc, Lupin said in a regulatory filing. The product will be manufactured at the company's Pithampur facility in India, it added. The company said Febuxostat tablets of strengths 40 mg and 80 mg are indicated for the chronic management of hyperuricemia (elevated serum uric acid level) in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol; who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. Febuxostat tablets had estimated annual sales of U

Lupin receives USFDA approval to market generic hypertension drug

Drug maker Lupin on Sunday said it has received approval from the US health regulator to market a generic hypertension drug in America. The company has received approval from the US Food and Drug Administration (USFDA) for Propranolol Hydrochloride extended-release capsules in multiple strengths, Lupin Ltd said in a regulatory filing. The company's product is the generic version of ANI Pharmaceuticals' Inderal LA extended-release capsules, it added. The product will be manufactured at the company's Pithampur-based manufacturing plant, the drug firm stated. Propranolol Hydrochloride extended-release capsules USP are indicated in the management of hypertension. They may be used alone or in combination with other antihypertensive agents, particularly a thiazide diuretic. As per IQVIA MAT November 2023 data, Propranolol Hydrochloride extended-release capsules had estimated annual sales of USD 71 million in the US.

Indian-American medical biller held for stealing more than $1 million

A 61-year-old Indian-origin medical biller has been arrested for stealing more than USD 1 million from doctors who provided medical care to injured workers in New York, according to the Attorney General's Office here. Amrish Patel and his two companies -- Medlink Services and Medlink Partners -- were charged on Wednesday with 27 felony counts for the thefts they allegedly committed from January 2012 through January 2019, New York Attorney General Letitia James announced. Patel and the companies were charged with one count of insurance fraud in the first degree, one count of grand larceny in the first degree, one count of grand larceny in the second degree, one count of grand larceny in the third degree, one count of scheme to defraud in the first degree, 11 counts of falsifying business records in the first degree and 11 counts of workers' compensation fraud. He was released with electronic monitoring and a USD 100,000 bond, according to the New York Attorney General's Office. Pate

Lupin gets USFDA approval to market generic medication to treat diabetes

Drug firm Lupin on Thursday said it has received approval from the US health regulator to market a generic medication to treat diabetes. The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application for Dapagliflozin and Saxagliptin tablets, the Mumbai-based drug maker said in a regulatory filing. The company's product is a generic equivalent of AstraZeneca AB's Qtern tablets, it added. This generic product will be manufactured at its Pithampur facility, the company said. Dapagliflozin and Saxagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. As per IQVIA data, Dapagliflozin and Saxagliptin tablets had estimated annual sales of USD 5 million in the US market.

Alembic Pharmaceuticals clinches eight USFDA approvals in Q3 FY24

The same day, Alembic Pharma's share price rose to 3.55 per cent, ending the day's trade at Rs 792 apiece on the BSE

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