Content about Regulatory and Washington

January 3, 2012

Mead Johnson Nutrition over the holidays conducted a new round of testing on samples of a batch of Enfamil Premium Newborn powdered formula related to a Food and Drug Administration investigation.

GLENVIEW, Ill. — Mead Johnson Nutrition over the holidays conducted a new round of testing on samples of a batch of Enfamil Premium Newborn powdered formula related to a Food and Drug Administration investigation.

Drawn from samples parallel to those being tested by public health officials and following the same methodology, the new testing did not detect any presence of Cronobacter (Enterobacter sakazakii), the company stated.

December 23, 2011

Rather than take off for Christmas, the editors of Drug Store News took a look at the year ahead and the stories, issues and trends that will make headlines in retail pharmacy in 2012.

Rather than take off for Christmas, the editors of Drug Store News took a look at the year ahead and the stories, issues and trends that will make headlines in retail pharmacy in 2012.

December 23, 2011

The Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee is set to review an investigational treatment for obesity.

MOUNTAIN VIEW, Calif. — The Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee is set to review an investigational treatment for obesity.

Biopharmaceutical company Vivus said the panel will review its new drug application for Qnexa on Feb. 22, 2012.

Meanwhile, the FDA will complete its review of the NDA for Qnexa on April 17, 2012. The regulatory agency accepted the NDA in November after Vivus' resubmission of the NDA in October.

December 23, 2011

The Food and Drug Administration on Thursday urged consumers to carefully read the labels of liquid acetaminophen marketed for infants to avoid giving the wrong dose to their infants.

SILVER SPRING, Md. — The Food and Drug Administration on Thursday urged consumers to carefully read the labels of liquid acetaminophen marketed for infants to avoid giving the wrong dose to their infants. Giving more than the recommended dose of acetaminophen can cause serious side effects and possibly death, the agency warned.

December 23, 2011

So far two retailers — Supervalu and Walmart — have pulled lots of Emfamil Premium Newborn powdered formula before any recall has been issued after learning of an infant's death this past weekend, according to published reports.

GLENVIEW, Ill. — So far two retailers — Supervalu and Walmart — have pulled lots of Emfamil Premium Newborn powdered formula before any recall has been issued after learning of an infant's death this past weekend, according to published reports.

December 22, 2011

Larry Hausner, the CEO of the American Diabetes Association, will serve as the 2012 chairman of the National Health Council's board of directors, NHC said.

WASHINGTON — Larry Hausner, the CEO of the American Diabetes Association, will serve as the 2012 chairman of the National Health Council's board of directors, NHC said.

December 22, 2011

Amneal Pharmaceuticals has launched its generic version of a drug designed to treat seizures in adults and children with epilepsy.

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has launched its generic version of a drug designed to treat seizures in adults and children with epilepsy.

The generic drug maker said it received approval from the Food and Drug Administration on Dec. 16 for felbamate oral suspension in the 600-mg/5-mL strength. The Amneal generic is available in two sizes, 8 fl. oz./240 mL and 16 fl. oz./473 mL. It is a generic version of Meda Pharmaceuticals' antiepileptic Felbatol.

December 22, 2011

McNeil Consumer Healthcare on Wednesday issued a voluntarily recall of certain lots of Motrin IB coated tablets from retailers.

FORT WASHINGTON, Pa. — McNeil Consumer Healthcare on Wednesday issued a voluntarily recall of certain lots of Motrin IB coated tablets from retailers. "This is not a consumer-level recall, which means that consumers do not need to dispose of or return the product," McNeil stated. 

McNeil is recalling these products because testing of product samples showed that some caplets may not dissolve as quickly as intended when nearing their expiration date.

December 21, 2011

The Food and Drug Administration has approved a new drug for high blood pressure made by Takeda, the drug maker said.

DEERFIELD, Ill. — The Food and Drug Administration has approved a new drug for high blood pressure made by Takeda, the drug maker said.

The Japanese drug maker received approval for Edarbyclor (azilsartan medoxomil and chlorthalidone) for the treatment of high blood pressure, also known as hypertension. The company called it the only fixed-dose therapy that combines an angiotensin II receptor blocker with chlorthalidone, a diuretic, in a once-daily, single tablet. The company also markets Edarbi, which only contains azilsartan medoxomil.

December 21, 2011

The branded subsidiary of Impax Labs has submitted a new drug application for its investigational idiopathic Parkinson's disease treatment to the Food and Drug Administration.

HAYWARD, Calif. — The branded subsidiary of Impax Labs has submitted a new drug application for its investigational idiopathic Parkinson's disease treatment to the Food and Drug Administration.

December 21, 2011

According to the National Community Pharmacists Association, changes governing long-term care facilities that recently were proposed by the Centers for Medicare and Medicaid Services could create turmoil for independent community pharmacies providing LTC services, the association stated in a release Wednesday.

ALEXANDRIA, Va. — According to the National Community Pharmacists Association, changes governing long-term care facilities that recently were proposed by the Centers for Medicare and Medicaid Services could create turmoil for independent community pharmacies providing LTC services, the association stated in a release Wednesday.

December 21, 2011

The Food and Drug Administration has approved an HIV drug for children and adolescents, the agency said Wednesday.

SILVER SPRING, Md. — The Food and Drug Administration has approved an HIV drug for children and adolescents, the agency said Wednesday.

The FDA announced the approval of Merck's Isentress (raltegravir) for HIV-1 infection in patients ages 2 to 18 years. The chewable form of the drug will be available for children ages 2 to 11 years.

"Many young children and adolescents are living with HIV, and this approval provides an important additional option for their treatment," FDA Office of Antimicrobial Products director Edward Cox said.

 

December 21, 2011

Ranbaxy Labs said Wednesday that it had resolved long-standing issues concerning two of its manufacturing plants in India with the U.S. government.

GURGAON, India — Ranbaxy Labs said Wednesday that it had resolved long-standing issues concerning two of its manufacturing plants in India with the U.S. government.

December 21, 2011

Drug maker Santarus has submitted a new drug application with the Food and Drug Administration for a treatment for ulcerative colitis, the company said.

SAN DIEGO — Drug maker Santarus has submitted a new drug application with the Food and Drug Administration for a treatment for ulcerative colitis, the company said.

The application was for Uceris (budesonide) tablets in the 9-mg strength for moderate active UC. The company is developing the drug under a collaboration with Cosmo Technologies.

 


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December 20, 2011

Pfizer is seeking approval from the Food and Drug Administration for its investigational treatment of moderately to severely active rheumatoid arthritis.

NEW YORK — Pfizer is seeking approval from the Food and Drug Administration for its investigational treatment of moderately to severely active rheumatoid arthritis.

The company said the FDA accepted a new drug application for tofacitinib for review. The agency also has provided an anticipated Prescription Drug User Fee Act action date of August 2012. Tofacitinib, which is a novel, oral JAK inhibitor, currently is under review by the European Medicines Agency.

December 20, 2011

The Pharmacy Technician Certification Board on Tuesday announced a push to inform patients with practical solutions on how to best utilize remaining 2011 flexible spending account funds.

WASHINGTON — The Pharmacy Technician Certification Board on Tuesday announced a push to inform patients with practical solutions on how to best utilize remaining 2011 flexible spending account funds.

December 20, 2011

The Council for Responsible Nutrition and VIRGO on Tuesday announced details for an industrywide webinar to examine key elements of good manufacturing practices for dietary supplements and offer advice as to what the industry can do to improve its record of inspections.

WASHINGTON — The Council for Responsible Nutrition and VIRGO on Tuesday announced details for an industrywide webinar to examine key elements of good manufacturing practices for dietary supplements and offer advice as to what the industry can do to improve its record of inspections. 

Moderated by Duffy MacKay, CRN VP scientific and regulatory affairs, the webinar will help companies better understand the intricacies of GMPs and will offer tips and best practices for passing Food and Drug Administration inspections.

December 19, 2011

The Food and Drug Administration has approved a drug for treating high blood pressure made by Mylan, FDA records showed.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug for treating high blood pressure made by Mylan, FDA records showed.

The FDA approved Mylan's metoprolol succinate tablets in the 25-mg, 50-mg, 100-mg and 200-mg strengths.

The drug is a generic version of AstraZeneca's Toprol-XL.

December 19, 2011

The Food and Drug Administration has approved a drug made by Sandoz for treating yeast and other fungal infections.

PRINCETON, N.J. — The Food and Drug Administration has approved a drug made by Sandoz for treating yeast and other fungal infections.

Sandoz announced Monday the approval of voriconazole tablets in the 50-mg and 200-mg strengths, a generic version of Pfizer's Vfend.

Branded and generic versions of the drug had sales of about $189 million during the 12-month period ended in October, according to IMS Health.

 

December 16, 2011

The Electronic Retailing Self-Regulation Program on Wednesday recommended that Emergent Health modify or discontinue certain Internet advertising claims for the company’s “JDI MultiVitamin,” promoted by the advertiser as designed to “increase adult stem cells.”

NEW YORK — The Electronic Retailing Self-Regulation Program on Wednesday recommended that Emergent Health modify or discontinue certain Internet advertising claims for the company’s “JDI MultiVitamin,” promoted by the advertiser as designed to “increase adult stem cells.” The marketer voluntarily modified several claims at issue in ERSP’s inquiry.

December 16, 2011

ViroPharma has received approval for updated labeling to its antibiotic drug.

EXTON, Pa. — ViroPharma has received approval for updated labeling to its antibiotic drug.

The drug maker announced that the Food and Drug Administration approved the "modernization" of labeling for Vancocin (vancomycin hydrochloride) capsules. The new label includes clinical safety and efficacy data for the drug in treatment strains of Clostridium difficile bacteria currency circulating.

December 16, 2011

The Obama administration on Thursday issued an interim final rule that will help prevent prescription drug shortages.

WASHINGTON — The Obama administration on Thursday issued an interim final rule that will help prevent prescription drug shortages.

The rule, the administration said, will require manufacturers (that are the sole producer of certain critical drugs) to report to the Food and Drug Administration all interruptions in manufacturing of products.

December 16, 2011

A new bipartisan bill introduced in the Senate seeks to protect consumers from Internet drug sellers posing as legitimate pharmacies.

ALEXANDRIA, Va. — A new bipartisan bill introduced in the Senate seeks to protect consumers from Internet drug sellers posing as legitimate pharmacies.

December 15, 2011

Approximately 5.3% of high school seniors abused over-the-counter cough-cold medicines in the past month, according to the latest "Monitoring the Future" survey released Wednesday by the National Institute on Drug Abuse.

WASHINGTON — Approximately 5.3% of high school seniors abused over-the-counter cough-cold medicines in the past month, according to the latest "Monitoring the Future" survey released Wednesday by the National Institute on Drug Abuse. That's down from 6.6% of high school seniors who claimed to have recently abused cough-cold medicines last year.

December 15, 2011

A Food and Drug Administration expert panel will review a drug made by NeurogesX as a potential treatment for pain associated with HIV.

SAM MATEO, Calif. — A Food and Drug Administration expert panel will review a drug made by NeurogesX as a potential treatment for pain associated with HIV.

NeurogesX said Thursday that the FDA Anesthetic and Analgesic Drug Products Advisory Committee would meet on Feb. 9, 2012, to review the patch drug Qutenza (capsaicin) as a treatment for pain associated with HIV-associated peripheral neuropathy, or HIV-PN.

The drug currently is approved for treating pain associated with postherpetic neuralgia.