Page 8 - Usfda

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, ...

Glenmark Pharma receives USFDA nod for generic anti-inflammatory drug

Glenmark Pharmaceuticals on Monday said it has received approval from the US health regulator to sell a generic version of anti-inflammatory drug in the American market. The company has received approval from the US Food and Drug Administration (USFDA) for Acetaminophen and Ibuprofen tablets (250 mg/125 mg), the Mumbai-based drug maker said in a statement. The company's product is the generic version of Haleon US Holdings, LLC's Advil 2 Dual Action with Acetaminophen Tablets, 250 mg/125 mg (OTC), it added. Glenmark Therapeutics Inc, USA will distribute the drug in the US market, the drug maker said. According to Nielsen syndicated data for the latest 52 weeks period ending March 23, 2024, the Advil Dual Action with Acetaminophen Tablets, 250 mg/125 mg achieved annual sales of around USD 84.1 million. Glenmark said its current portfolio consists of 195 products authorised for distribution in the US marketplace and 52 abbreviated new drug applications (ANDAs) pending approval with

USFDA gathering information on Indian spices after alleged contamination

Hong Kong this month suspended sales of three MDH spice blends and an Everest spice mix for fish curries. Singapore ordered a recall of the Everest spice mix as well

US FDA gathering information on Indian spices after alleged contamination

MDH and Everest spices, which are among the most popular names in India and are also sold in Europe, Asia and North America, are also under the Indian regulator's scanner

Zydus Life stock sheds 5% as USFDA issues 10 observations for Vadodara unit

Zydus Lifesciences share price update: The USFDA conducted an inspection at the Injectable Manufacturing site situated at Jarod, near Vadodara, between April 15 and April 23, 2024

USFDA pulls up Natco Pharma for several violations at Telangana plant

Natco Pharma failed to maintain cleanliness, sterilise equipment and utensils at appropriate intervals at its Telangana-based plant, as per the US health regulator. In the warning letter to the company, US Food and Drug Administration said its investigators observed various violations at the finished pharmaceuticals plant located at Kothur Village in Telangana. The USFDA inspected the facility from October 9 to 18, 2023. "Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilise equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements," the US health regulator noted. It further said: "Your cleaning procedure for your non-dedicated equipment is inadequate." Cross-contamination is not uniform, and the testing of control samples and placebo batches failed to ...

Glenmark Pharma recalls 6,528 bottles of blood pressure drug in US

Glenmark Pharmaceuticals is recalling 6,528 bottles of a medication used to treat high blood pressure in the American market due to failed dissolution specifications, the US health regulator said. The US-based arm of the Mumbai-headquartered drug firm is recalling the affected lot of Diltiazem Hydrochloride extended-release capsules, the US Food and Drug Administration said in its latest Enforcement Report. The affected lot has been produced in India and is being recalled by New Jersey-based Glenmark Pharmaceuticals Inc for "failed dissolution specifications", the USFDA said. "Out of Specification (OOS) was reported in a test of dissolution at the 12th month time point in long-term stability study," it noted. Glenmark initiated Class II recall of the drug across the US on March 26 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

USFDA issues 'warning letter' to Kilitch Healthcare over GMP violation

The FDA questioned Kilitch's quality system, citing concerns about its ability to ensure data accuracy and integrity for drug safety

Natco Pharma receives warning letter from USFDA for Telangana plant

Natco Pharma on Tuesday said it has received a warning letter from the US health regulator for its Telangana-based manufacturing plant. The US Food and Drug Administration (USFDA) had issued eight observations under Form 483 after inspecting the company's Kothur-based formulation facility. The inspection was conducted by USFDA from October 9 to October 18, 2023. "We wish to inform you that the company has received a warning letter dated April 8, 2024 from the USFDA," the drug firm said in a regulatory filing. The company does not believe that the warning letter will have an impact on supplies or the existing revenues from this facility, it added. "It may cause delay/withholding of pending product approvals from this site," Natco Pharma said. The drug firm will respond to the letter within the stipulated timelines and work closely with the USFDA to address the concerns in a holistic and timely manner to ensure sustained compliance, it said. A warning letter is issued when the US

Wardwizard Foods & Beverages to enters US mkt as it gets USFDA registration

Wardwizard Foods and Beverages, maker of frozen and ready-to-eat foods, on Monday announced its foray into the US market following the USFDA registration. The Vadodara, Gujarat-based company will commence exporting to US market in the first quarter of this fiscal, according to a statement from the company. "The initial phase will focus on key cities including Chicago, New Jersey and Texas, where consumers will have the chance to indulge in the rich and authentic tastes of India's culinary offerings," it said. The firm offers convenient RTE (ready-to-eat) meals to frozen products, spices, savory sauces, condiments, and beverages. Chairperson and Managing Director Sheetal Bhalerao said: "The attainment of USFDA registration stands as a validation to our product quality and regulatory compliance.

Zydus Lifesciences gets 4 observations from USFDA for Gujarat plant

Zydus Lifesciences on Wednesday said the US health regulator has issued a Form-483 with four observations following the inspection of its Ahmedabad-based SEZ Onco Injectable manufacturing plant. The US Food and Drug Administration (USFDA) conducted the cGMP (Current Good Manufacturing Practice) inspection at the facility from March 18-27, 2024, the company said in a regulatory filing. The inspection closed with four observations, it added. There were no data integrity-related observations, the drug firm said. Zydus will closely work with the USFDA to address the observations, it added. Shares of the company ended 1.82 per cent lower at Rs 999.60 apiece on BSE.

Lupin gets USFDA nod to market a generic drug to treat bacterial infections

Drug maker Lupin on Friday said it has received approval from the US health regulator to market a generic medication to treat bacterial infections, in America. The company has received approval from the USFDA for Doxycycline for Injection USP, the Mumbai-based drug maker said in a statement. The company's product is the generic equivalent of Pfizer Inc's Vibramycin for injection, it added. The product will be manufactured at its Nagpur facility, Lupin said. Doxycycline for Injection USP is indicated to reduce the development of drug-resistant bacteria. As per the IQVIA MAT January 2024 data, Doxycycline for Injection USP had estimated annual sales of USD 47 million in the US market.

Sun Pharma recalls around 55,000 bottles of generic medication in US

Sun Pharma is recalling about 55,000 bottles of a generic medication to treat bowel disease in the American market, according to the US Food & Drug Administration (USFDA). As per the latest Enforcement Report by the US health regulator, New Jersey-based Sun Pharmaceutical Industries Inc, a unit of the Mumbai-headquartered drug major, is recalling 54,960 bottles of Mesalamine extended-release capsules in the American market. Mesalamine delayed-release capsules are indicated for the treatment of mild to moderate ulcerative colitis. The affected lot of capsules have been manufactured by Sun Pharmaceutical Industries at its Mohali-based manufacturing plant and distributed in the US market by Sun Pharmaceutical Industries Inc. As per the USFDA, the company has initiated the Class II recall due to "Failed Dissolution Specifications". The company initiated the Class II recall on February 5 this year. As per the USFDA, a class II recall is initiated in a situation in which the use of, or

Strides Pharma receives USFDA approval for neurology medication Gabapentin

Gabapentin is widely used in managing neuropathic pain associated with diabetic neuropathy, postherpetic neuralgia, and central pain