Page 8 - Usfda

Wanbury surges 5% after USFDA issues Zero observations for Patalganga site

At 9:55 AM, the shares were off highs, trading 2.25 per cent higher at Rs 163.95 per share. In comparison, BSE Sensex was trading 0.16 per cent lower at 77,211.40 levels.

Alembic gets USFDA nod for generic injection to treat hereditary angioedema

Alembic Pharmaceuticals Ltd on Monday said it has received final approval from the US health regulator for its generic Icatibant injection indicated for the treatment of acute attacks of hereditary angioedema in adults. The approval by the US Food & Drug Administration (USFDA) is for the Abbreviated New Drug Application (ANDA) for Icatibant injection of strengths 30 mg/3 mL (10 mg/mL) single-dose prefilled syringe, Alembic Pharmaceuticals said in a regulatory filing. This is the first peptide product approval from the USFDA received by the company, Alembic Pharma said. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Firazyr Injection, 30 mg/3 mL (10 mg/mL), of Takeda Pharmaceuticals USA, Inc, it added. Icatibant injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. Hereditary angioedema is a disorder characterised by recurrent episodes of severe swelling (angioedema)

USFDA closes inspection of Lupin's facility with zero 483 observations

The inspection of the Nagpur facility was carried out by the US drug regulator from June 10 to June 13, 2024

Zydus gets tentative nod from USFDA for blood pressure lowering drug

Zydus Lifesciences Ltd on Friday said it has received tentative approval from the US health regulator to market Azilsartan Medoxomil and Chlorthalidone tablets, which are indicated for the treatment of high blood pressure. The tentative approval by the US Food and Drug Administration (USFDA) is for Azilsartan Medoxomil and Chlorthalidone tablets of strengths 40 mg/12.5 mg and 40 mg/25 mg, Zydus Lifesciences said in a regulatory filing. Azilsartan and Chlorthalidone are diuretic combination products indicated for the treatment of high blood pressure to lower blood pressure, it added. The drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ- II, India, the company said. Azilsartan Medoxomil and Chlorthalidone tablets had annual sales of USD 77.9 million in the US, Zydus Lifesciences said citing IQVIA MAT March 2024 data.

Senators blast health, police officials over illegal sales of e-cigarettes

Senators on Wednesday blasted top health and law enforcement officials for not doing more to combat the rise of illegal electronic cigarettes in the U.S., a multibillion-dollar business that has flourished amid haphazard enforcement. Democrats and Republicans on the Senate Judiciary Committee expressed frustration and exasperation while questioning officials from the Food and Drug Administration and Justice Department about attempts to stay on top of the vaping industry, which has grown to include thousands of flavored, unauthorized e-cigarettes originating in China. Those products, including brands like Elf Bar, have become the most popular choice among American teens who vape. I simply do not understand how FDA and DOJ have permitted thousands of products to remain on store shelves when their manufacturers have not received authorization, or, in some cases, even filed an application, said the committee's chairman, Dick Durbin. The Illinois Democrat displayed a photo of a shelf ..

US FDA grants accelerated approval to Genfit, Ipsen's liver disease drug

Ipsen added that standard approval for Iqirvo may be contingent on confirmatory trials

USFDA issues Form 483 with four observations to Dr Reddy's API unit

Dr Reddy's Laboratories on Friday said the US health regulator has issued Form 483 with four observations after inspecting its Andhra Pradesh-based API manufacturing facility. The US Food & Drug Administration (USFDA) today completed a GMP inspection at the company's API manufacturing facility (CTO-6) in Srikakulam, Andhra Pradesh, the Hyderabad-based drug major said in a regulatory filing. The inspection was conducted from May 30, 2024 to June 7, 2024, it added. "We have been issued a Form 483 with four observations, which we will address within the stipulated timeline," the drug firm said. 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.

Covid shots should target JN.1, KP.2 subvariants in 2024-25 campaign: USFDA

FDA reviewers said since the difference between JN.1 and newer subvariants such as KP.2 subvariants is not much, it is possible that vaccines developed against JN.1 may adequately protect against KP.2

Delaware judge allows more than 70,000 Zantac lawsuits to go forward

In 2019, some manufacturers and pharmacies halted Zantac sales after a chemical called NDMA, which is known to cause cancer, was detected in some pills

Sun Pharma, Dr Reddy's pull drugs in US over manufacturing issues: USFDA

Sun Pharma and Dr Reddy's Laboratories are recalling products in the American market due to manufacturing issues, the US Food and Drug Administration (USFDA) has said. In its latest Enforcement Report, the US health regulator stated that a US-based unit of Sun Pharma is recalling 35,069 bottles of medication used to treat high pressure inside the eye due to glaucoma or other eye diseases. New Jersey-based Sun Pharmaceutical Industries Inc is recalling the affected lot of Xelpros (latanoprost ophthalmic emulsion) due to "out of specification for particulate matter test". The company initiated the voluntary Class III recall in the US on April 22 this year, the USFDA stated. In a separate filing, the USFDA stated that a US-based arm of Dr Reddy's Laboratories is recalling 1,176 bottles of an immunosuppressant medication. Dr Reddy's Laboratories Inc is recalling the affected lot of Sirolimus Tablets due to "Failed Impurities/Degradation Specifications", the USFDA said. The company ...

Indian pharmaceutical companies likely to cash in on US drug shortages

US drug shortages hit a decade-high of 323 across 22 therapies in the March quarter of 2024

Aurobindo Pharma Q4 results: PAT rises 79.5% to Rs 908 cr, revenue up 14.8%

The increase in PAT is attributed to expansion into the new markets, product launches and stable pricing

Cipla receives USFDA approval to market Lanreotide injection in US

Drug major Cipla on Wednesday said it has received approval from the US health regulator to market a generic medication used to treat acromegaly and other conditions. The company has received the final approval from the US Food and Drug Administration (USFDA) to market Lanreotide injection in multiple strengths, the Mumbai-based drug maker said in a statement. The company's Lanreotide Injection is therapeutic equivalent generic version of Somatuline Depot Injection, it added. The drugmaker said its product is indicated for the treatment of patients with acromegaly and gastroenteropancreatic neuroendocrine tumours. According to IQVIA (IMS Health), Somatuline Depot had sales of around USD 898 million in the US for the 12-month period ending March 2024.

Drug makers Dr Reddy's, Sun Pharma, Aurobindo recall products in US market

Drug makers Dr Reddy's Laboratories, Sun Pharma and Aurobindo Pharma are recalling products in the US market due to manufacturing issues, as per the latest Enforcement Report of the US Food and Drug Administration (USFDA). Dr Reddy's Laboratories is recalling close to 20,000 cartons of a medication used to control blood phenylalanine levels in adults and children. Princeton (New Jersey) based Dr Reddy's Laboratories, Inc, is recalling Javygtor (sapropterin dihydrochloride) Powder for Oral Solution (100mg) due to it being a "Sub-potent Drug", USFDA stated. The company is also recalling another lot of sapropterin dihydrochloride for the same reason, it added. The USFDA said the drug maker initiated the Class I recall in the US on April 8 this year. As per the US health regulator, a Class I recall pertains to defective products that can cause serious health problems. The USFDA said Sun Pharma is recalling 11,016 vials of Amphotericin B Liposome for Injection, used to treat fungal ...

Pharma major Glenmark gets USFDA nod for generic ophthalmic solution

Glenmark Pharmaceuticals Ltd on Friday said it has received final approval from the US health regulator for its generic brimonidine tartrate and timolol maleate ophthalmic solution indicated in the treatment increased pressure in the eye caused by glaucoma or other conditions. The final approval by the US Food & Drug Administration (USFDA) is for brimonidine tartrate and timolol maleate ophthalmic solution of strength 0.2 per cent/0.5 per cent, Glenmark said in a statement. The company's brimonidine tartrate and timolol maleate ophthalmic solution, 0.2 per cent/0.5 per cent has been determined by the USFDA to be bioequivalent and therapeutically equivalent to Combigan ophthalmic solution, 0.2 per cent/0.5 per cent of AbbVie, Inc, it added. The solution will be distributed in the US by Glenmark Pharmaceuticals Inc, USA, it added. Combigan ophthalmic solution, 0.2 per cent/0.5 per cent achieved annual sales of approximately USD 290 million, the company said citing IQVIATM sales data

USFDA issues Form 483 with 1 inspectional observation to Cipla's Maha unit

Pharma major Cipla Ltd on Wednesday said it has received one inspectional observation in Form 483 from the US health regulator for its manufacturing facility at Kurkumbh in Maharashtra. 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. A routine current Good Manufacturing Practices (cGMP) inspection was conducted by the USFDA at the company's manufacturing facility at Kurkumbh, Maharashtra from April 29, 2024, to May 8, 2024, Cipla said in a regulatory filing. "On conclusion of the inspection, the company has received one inspectional observation in Form 483," it added. The company will work closely with the USFDA and is committed to addressing this observation comprehensively within the stipulated time, Cipla said.

Cipla, Glenmark recall drugs from US over manufacturing issues: USFDA

Drug makers Cipla and Glenmark are recalling products from the American market due to manufacturing issues, according to the US health regulator. As per the latest Enforcement Report issued by the US Food and Drug Administration (USFDA), a New Jersey-based subsidiary of Cipla is recalling 59,244 packs of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution. The medication, produced at the company's Indore SEZ plant, is used to help control the symptoms of lung diseases, such as asthma, chronic bronchitis and emphysema. Cipla USA is recalling the affected lot due to "short fill". There were complaints of less fill volume in respule and few drops of liquid observed in the intact pouch, USFDA said. Cipla initiated the Class II recall in the US market on March 26 this year. USFDA also said that Glenmark Pharma is recalling 3,264 bottles of Diltiazem Hydrochloride extended-release capsules indicated for high blood pressure. The US-based arm of the company -- Glenmark ...

Abbott launches XIENCE Sierra coronary stent system for heart patients

The XIENCE Sierra is the latest generation of the XIENCE family of everolimus-eluting coronary stent systems

All ground beef samples test negative for H5N1 bird flu virus: USDA

The US Food and Drug Administration said preliminary results of tests on additional dairy products show pasteurization inactivates the bird flu virus

In a historic shift, US govt poised to ease restrictions on marijuana

The US Drug Enforcement Administration will move to reclassify marijuana as a less dangerous drug, The Associated Press has learned, a historic shift to generations of American drug policy that could have wide ripple effects across the country. The proposal, which still must be reviewed by the White House Office of Management and Budget, would recognise the medical uses of cannabis and acknowledge it has less potential for abuse than some of the nation's most dangerous drugs. However, it would not legalise marijuana outright for recreational use. The agency's move, confirmed to the AP on Tuesday by five people familiar with the matter who spoke on the condition of anonymity to discuss the sensitive regulatory review, clears the last significant regulatory hurdle before the agency's biggest policy change in more than 50 years can take effect. Once OMB signs off, the DEA will take public comment on the plan to move marijuana from its current classification as a Schedule I drug, ...