FDA scolds Merck for missing Januvia deadline
U.S. regulators have slapped Merck ($MRK) with a warning letter for dragging its feet in conducting a pancreatic safety study in rodents for its diabetes drug Januvia, a blockbuster product that has made billions for the drugmaker but also has been linked with a troubling safety issue. Whitehouse Station, NJ-based Merck was supposed to have […]
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FDA warning: Counterfeit version of cancer drug Avastin circulating
Some cancer patients may not get proper treatment because a counterfeit version of the drug sold as Avastin 400mg/16mi has been purchased by as many as 19 medical practices in the United States, FDA warned Wednesday. Avastin is used to treat certain types of cancer, including lung cancer and cancer of the colon (large intestine) […]
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FDA issues warning to Grand Isle NY drugmaker
APP Pharmaceuticals, a Grand Island NY drugmaker, has received a warning letter from the Food and Drug Administration. The letter notified the Staley Road manufacturer that the FDA expects it to “undertake a comprehensive and global assessment†of its operations, particularly its “aseptic processing capabilities.†The FDA inspected the plant in July, citing several “significant […]
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Merck Gets FDA Warning Letter on Drug Study
FDA said Merck & Co . failed to meet a requirement to conduct a safety study in rodents of its blockbuster diabetes drug Januvia. The FDA issued a warning letter to Merck on Feb. 17, saying Merck was months late in submitting information about the required study to the agency. The FDA instructed Merck to […]
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FDA adds diabetes, memory loss warnings to statins
Health regulators are adding warnings to the labels of widely used cholesterol lowering drugs, such as Lipitor, to say they may raise levels of blood sugar and could cause memory loss. The Food and Drug Administration announced on Tuesday the changes to the safety information on the labels of statins such as Pfizer Inc’s Lipitor, […]
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FDA Sends Serious Warning Letter to Lab for All Using 1 Login
This February warning letter from FDA found that Biochem Laboratory’s contract testing lab in NJ was having all of its employees utilizing the exact same username and password. This led FDA to question the computer systems and data integrity of Biochem’s entire operation. Biochem responded that it would provide all users with their own usernames […]
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Senior Exec Leaves Novartis After Major Quality Problems
Source: Pharmalot Exactly one year after joining Novartis to run its over-the-counter division and less than two months after joining the executive committee, Naomi Kelman has resigned from the drugmaker and her replacement at the OTC unit is Brian McNamara, according to a statement. Her departure comes on the heels of an embarrassing and costly […]
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Merck’s Januvia and Janumet Misbranded, FDA Says
Source: Pharmalot The FDA has decided that the Januvia and Janumet diabetes meds sold by Merck are misbranded, because the drugmaker failed to submit an agreed-upon post-marketing study, which the agency had required to assess the risk of acute pancreatitis. The disclosure came in a warning letter that the FDA sent to Merck in which […]
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APP Pharmaceuticals Cited for Major Quality Problems, Bugs
Source: Pharmalot File this under ‘a fine mess.’ The FDA has tagged APP Pharmaceuticals for so many systemic problems -insects; vials with missing labels; failed assays; contamination; floating particles and a failure to file reports or follow-up complaints – that the agency has instructed the executive team to “undertake a comprehensive and global assessment,†according […]
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Pfizer recalls Prevnar pneumococcal vaccine
Drugmaker Pfizer Inc. is recalling one lot of its blockbuster vaccine against pneumococcal disease, Prevnar 13. Pfizer says the lot is being recalled from a drug wholesaler because Pfizer found the active ingredient was past its expiration date. The company says none was distributed to health care providers. Prevnar 13 protects against 13 strains of […]
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