FDA confirms Mylan's version is only approved amlodipine
The FDA has confirmed Mylan's current status of having the only approved ANDA for all strengths of amlodipine besylate, which is a generic version of Pfizer's Norvasc
GPhA calls on Senate to include bipartisan biogenerics rule
Jaeger declared that the Senate must enact a clear, efficient, and abbreviated approval pathway to ensure timely access to biogenerics
GPhA: Medicare could save billions with biogenerics
GPhA declared that the availability of safe and effective generic versions of biopharmaceuticals, or biogenerics, could save the Medicare system billions of dollars annually.
PhRMA reports that many kids' meds are being tested
A new report released by PhRMA said there are 219 medicines currently in clinical trials or under review by the FDA for use in children.
FDA makes drug safety podcasts available
Healthcare professionals can now access emerging drug safety information via podcasts, according to the FDA.
New dose approved for injectable risperidone
The FDA has given the green light for a 12.5-mg dose of the long-acting injectable formulation of risperidone, Risperdal Consta, from Alkermes and Janssen.
CtW urges: 'Vote No' against CVS/Caremark directors
The CtW Investment Group is urging fellow CVS/Caremark shareholders to withhold their votes from former Caremark directors.
Duane Reade partners with Together Rx Access
Duane Reade, a drugstore chain in metropolitan New York, and Together Rx Access, a free prescription savings program, have partnered to help eligible New Yorkers without health insurance gain access to prescription medicines.
Wal-Mart to open 400 clinics in next three years
Wal-Mart intends to contract with local hospitals and other organizations to open as many as 400 in-store health clinics over the next two to three years.
Poll: Americans support FDA regulation of tobacco
77% of American voters support Congress' passing a bill to give the FDA the authority to regulate tobacco products.
NCPA partners with HME member service organization
NCPA and the VGM Group, a member service organization for home medical equipment (HME) providers, have announced an alliance that will help NCPA members enter the HME market or advance their HME business.
Little change in Part D enrollment for 2007
The Medicare Part D prescription drug plan market changed little with the second open-enrollment period, despite changes in plan benefits and formularies.
PBM says many seniors could have avoided donut hole
According to an analysis of 2006 prescription drug claim histories by PBM Express Scripts, 23% of seniors who fell into the Medicare Part D donut hole coverage gap could have avoided it altogether by using more generics.
Santa Clara to add MTM to Part D plan
Eligible members will receive an annual medication review as well as additional MTM services from trained pharmacists to help them achieve safe and effective results from their medications while controlling costs.
Distribution stopped at AmerisourceBergen Orlando facility
DEA claims that AmerisourceBergen did not maintain effective controls against diversion of controlled substances, specifically hydrocodone, to four Internet pharmacies from Jan. 1, 2006, through Jan. 31, 2007.
Maker of unapproved drugs agrees to stop illegal practices
PharmaFab is a major contract manufacturer and distributor of more than 100 different Rx and OTC products, including cough and cold products, ulcer treatments, and postpartum hemorrhage products.
AstraZeneca buying MedImmune
British pharmaceutical giant AstraZeneca announced it is acquiring Gaithersburg, Md.-based MedImmune for $15.6 billion.
FDA gives the go-ahead for generic Ambien
The sedative-hypnotic is indicated for the short-term treatment of insomnia. Zolpidem tablets in formulations of 5 and 10 mg are manufactured by multiple U.S. generic drug companies.
Biotech exec stresses clinical trials for follow-on biologics
"We strongly feel that not only should the FDA do guidance prior to approving, but also require clinical evidence."
San Francisco bans disposable bags in pharmacies
San Francisco supervisors recently passed the first ban in the nation on plastic bags. The bill applies to large grocers and all pharmacies in the city and bans the use of petroleum-based bags.
CVS unveils Extra Bucks Now
CVS unveiled added benefits to customers of its ExtraCare program, including the introduction of Extra Bucks Now.
PPA to connect uninsured children to health program
America?s pharmaceutical research companies, YMCA of the USA, and Easter Seals have joined forces to help uninsured children access health care.
Pharmacy staff can impact retail pharmacy experience
Medicine Shoppe pharmacies led the retail chain segment, receiving the highest ratings in all factors driving customer satisfaction.
IRI study: Capitalize on health and wellness
The study is the first in a phase of solutions that IRI will be releasing on health and wellness opportunities.
Rite Aid to close Brooks Eckerd deal by end of May
Rite Aid expects to close its acquisition of the Brooks and Eckerd drugstore chains by the end of May
Medicare Part D ready for e-prescribing
The Medicare Modernization Act requires HHS to develop uniform standards for the electronic transmission of prescriptions.
Donut hole to swallow more seniors
Cardiovascular disease and diabetes are expected to be the therapeutic areas most impacted by the coverage gap
FDA approves single-dose treatment for Paget's disease
The FDA has approved zoledronic acid (Reclast, Novartis) injection as the first new treatment in nearly a decade for patients with the bone condition Paget's disease
Financial incentives won't change consumer behavior
CDHP participants were less likely than traditional health plan enrollees to change behavior and take advantage of cost-saving generic drugs, instead opting to curtail brand-medication use.
Celgene launches patient support program for myeloma
Support Coordinators are oncology nurses and other trained professionals available by phone to help patients work their way through the complexities of drug access and reimbursement.