Just when Biogen Idec and Elan were hoping for the red light to turn green, it changed to yellow instead, as the FDA announced it would wait up to another 90 days before giving its final decision on the reintroduction of natalizumab (Tysabri). According to the FDA, extensions such as this often occur after a manufacturer submits a major amendment to the existing application, requiring extra time for the agency to review.
Seattle-based Bartell Drugs announced the purchase of Fairwood Pharmacy, a family-owned drugstore serving the Renton, Wash., area since 1970. With the acquisition, Bartell Drugs will own and operate 53 stores in King, Pierce, and Snohomish counties. The store will operate under the Bartell Drugs banner.
Kroger Co. has filed a civil antitrust lawsuit against Sanofi-Aventis, Bristol-Myers Squibb, and Apotex Inc., alleging the three drugmakers have entered into an illegal settlement of a patent lawsuit involving the blood thinner, Plavix (clopidogrel). In documents filed in the U.S. District Court in the Southern District of Ohio, Kroger said the three drug firms, in settling a dispute over the patent for Plavix, agreed to keep the patent protection for the drug in place until 2011.
Wyeth is launching "Dialogues: Time to Talk," a nationwide program for Spanish-speaking patients with depression who are taking Effexor XR (venlafaxine HCl). Patients who enroll in the program will receive educational materials.
CMS began notifying 500,000 Medicare beneficiaries enrolled in two Part D plans that they must indicate which plan they wish to use for their drug benefit. Beneficiaries who want to remain in their original plan must contact the insurer, while beneficiaries who do nothing will be dropped from their original plan and remain covered by the second plan.
A group of seven drug plans has filed a class action lawsuit against Pfizer Inc., claiming the company used off-label promotion of atorvastatin (Lipitor) to boost sales. According to New York-based Grant & Eisenhofer, P.A., the securities litigation firm representing the group, the plaintiffs contend that Pfizer's physician and hospital marketing materials have misrepresented treatment protocols established by the National Cholesterol Education Program's Adult Treatment Panel III (ATP III), and that the drug was approved by the FDA only for use in accordance with ATP III.
Which were the top 10 branded biotech drugs in 2005? In descending order, they are Procrit, followed by Aranesp, Epogen, Neulasta, Remicade, Enbrel, Rituxan, Lupron Depot, Lantus, and Avastin.
Since 1998, the Food & Drug Administration has had theregulatory authority to require pharmacies to distribute MedicationGuides to patients getting certain high-risk drugs. MedGuides,which provide written information to patients on their Rxs, areprepared by drug manufacturers and approved by the FDA. To date,the FDA lists more than 75 drugs on its Web site that require thedistribution of a MedGuide from a community pharmacy or uponhospital discharge. They include antidepressants, nonsteroidalanti-inflammatory drugs (NSAIDs), and others. Manufacturers ofthese high-risk drugs are responsible for ensuring that asufficient number of MedGuides are available in pharmacies.
The Food & Drug Administration would like to alert healthcare practitioners to three cases of medication dispensing errors in which the Alzheimer's medication Razadyne (galantamine, Janssen Pharmaceutica) was dispensed instead of the insomnia agent Rozerem (ramelteon, Takeda Pharmaceuticals) to geriatric patients. In two cases the wrong drug was actually administered to the patient but with no reported adverse outcomes, while the third error was caught prior to patient administration. Errors between these products could result in unnecessary adverse events or lack of efficacy.
Pharmacists say Medicare Part D caused chaos in their pharmacies at start-up; they hope for better days ahead
Among the sources of confusion accompanying the implementation of Medicare Part D is the distinction between drugs covered under Part B and Part D. CMS officials held a teleconference late in January to listen to provider concerns, answer questions, and correct misinterpretation.
The third echinocandin to hit the market in five years, anidulafungin (Eraxis, Pfizer) received Food & Drug Administration approval in February and joins both caspofungin (Cancidas, Merck) and micafungin (Mycamine, Astellas Pharma) in the fight against fungal infections in seriously ill patients. Anidulafungin is indicated to treat candidemia, other forms of Candida infections (intra-abdominal infections and peritonitis), and esophageal candidiasis.
CVS Corp. has reached an agreement with 42 states and the District of Columbia by promising to strengthen practices that keep minors from buying tobacco products. Under the voluntary settlement, the pharmacy chain agreed to check the identities of customers who attempt to purchase tobacco products if they look younger than 27.
Food retailers are differentiating their businesses from competition by launching target market-focused stores and expanding specialty services, according to the 2005 edition of the Food Marketing Institute (FMI) study, "Facts About Store Development." In-store pharmacies (55.7% of companies) continue to be a popular feature.
Seniors who take multiple medications are at increased risk for accidental poisonings, according to ASHP. Older patients have complex medication regimens, often involving multiple medications prescribed by several physicians, which make them vulnerable to accidental poisonings.
Longs Drug Stores announced a new long-term supply contract with AmerisourceBergen Drug Corp. for the supply of prescription pharmaceutical products. The agreement will become effective July 1, 2006, and will run for a term of at least three and as long as seven years, with the actual duration depending on the time when the company's total purchases of branded prescription pharmaceuticals under the agreement reach a certain amount.
Reimbursement for retail and mail-service pharmacy continues to decrease, according to the findings of the Prescription Drug Benefit Cost and Plan Design Survey Report, conducted by the Pharmacy Benefit Management Institute (PBMI). The average retail brand-drug dispensing fee decreased from $2.05 in 2003 to $1.95 in 2004.
H.D. Smith, the fourth largest national pharmaceutical wholesaler, was recently awarded a multiyear agreement with Novation, the healthcare contracting service organization, to provide members of VHA Inc. and University HealthSystem Consortium (HC) with H.D. Smith's extensive list of products and services.
A Palm Beach, Fla., woman is suing Walgreens on grounds that when she picked up a prescription for the sleep aid Ambien (zolpidem, Sanofi-Aventis), she found a message attached in the section reserved for patient information that said "Crazy!" The patient, Janey Karp, said the prescription also said, "She's really a psycho! Do not say her name too loud, never mention her meds by names, and try to talk to her when..." The information continued on to another page, which was not attached. Karp is suing for defamation, negligent supervision, and intentional infliction of emotional distress.
Following reports of two fatalities in women who took mifepristone (Mifeprex, Danco Laboratories) to terminate their pregnancies, the FDA has issued a public health advisory to providers and patients. The agency said they are investigating the cases, but at this time are not certain of the exact cause of death.
A new monophasic oral contraceptive (OC) from Berlex Inc. may offer women less hormonal fluctuation between monthly cycles than traditional OCs. Yaz contains both 3 mg of drospirenone and 20 mcg ethinyl estradiol in a 24-day active pill regimen-a longer period of time than traditional OCs, which typically provide 21 days of hormone-containing tablets.
At the 2006 annual APhA meeting, information was released showing that pharmacists overestimate the number of interactions between drugs and grapefruit juice. A follow-up survey performed by KRC Research for the Florida Department of Citrus has found that while 50% more pharmacists are well informed regarding grapefruit juice interactions compared with the results of the initial 2002 survey, many pharmacists still need more specific information.
Just as pharmacists can get board-certified in certain specialties, technicians could show that they are trained to work in certain settings down the line. At present, there is only one Pharmacy Technician Certification Board exam for technicians.
Not only more female but also more male pharmacists are practicing part-time. On top of that, more than 40% of male pharmacists are approaching retirement or are over the age of 55.
Already approved as a subcutaneous or intravenous infusion for the treatment of pulmonary arterial hypertension (PAH), treprostinil sodium (Remodulin, United Therapeutics) for injection has received expanded label approval from the FDA and can now also be used to diminish the rate of clinical deterioration in patients requiring transition from epoprostenol sodium (Flolan, GlaxoSmithKline). United Therapeutics said it has also successfully completed a phase IV postmarketing study as part of an FDA Subpart H accelerated approval requirement.
By reducing medication discrepancies, pharmacist counseling of and follow-up with hospitalized patients at discharge were associated with lower rates of preventable adverse drug events, according to a randomized study of 178 general medicine patients. The study appeared in the March 13 issue of Archives of Internal Medicine.
The Food & Drug Administration has been counting on radio frequency identification (RFID) technology to be ready for widespread adoption next year, allowing drug product packages to be tagged with tiny chips containing an electronic product code or unique electronic serial number. Now the agency thinks that may not happen and is in a bit of a quandary.
The first in a new class of drugs, lubiprostone (Amitiza, Sucampo/Takeda) was approved by the Food & Drug Administration in late January for the treatment of chronic idiopathic constipation in the 33 million adults the condition is estimated to affect. It is responsible for 92,000 hospitalizations annually and is more common in women and in patients over the age of 65.
The first in a new class of drugs, lubiprostone (Amitiza, Sucampo/Takeda) was approved by the Food & Drug Administration in late January for the treatment of chronic idiopathic constipation in the 33 million adults the condition is estimated to affect. It is responsible for 92,000 hospitalizations annually and is more common in women and in patients over the age of 65.