Content about Pharmaceutical sciences

March 20, 2013
Doctors, public health experts want more FDA regulation of energy drinks

A group of doctors and public health professors are hoping the Food and Drug Administration will place stronger regulations on energy drinks to protect children and adolescents from what they call the harmful effects of high caffeine consumption.

NEW YORK — A group of doctors and public health professors are hoping the Food and Drug Administration will place stronger regulations on energy drinks to protect children and adolescents from what they call the harmful effects of high caffeine consumption.

March 20, 2013
HRG launches ranking system for top prescriptions by ZIP code

Hamacher Resource Group is offering pharmacists a new service that it said would allow them to get the top prescriptions dispensed in their two-digit ZIP code to ensure they are accurately and competitively pricing drugs.

WAUKESHA, Wis. — Hamacher Resource Group is offering pharmacists a new service that it said would allow them to get the top prescriptions dispensed in their two-digit ZIP code to ensure they are accurately and competitively pricing drugs.

HRG said the service, Rx Top Sellers, would provide data on the top 200, 500, 750 or 1,000 prescriptions and include cash median prices that are charged by food-drug retailers and independent pharmacies, as well as mass merchandise retailers.

March 20, 2013
Sandoz launches generic contraceptives

The Food and Drug Administration has approved and launched two generic contraceptives made by Sandoz, the drug maker said.

PRINCETON, N.J. — The Food and Drug Administration has approved and launched two generic contraceptives made by Sandoz, the drug maker said.

Sandoz, the generics division of Swiss drug maker Novartis, announced the approval of Estarylla (norgestimate and ethinyl estradiol tablets) and Tri-Estarylla (norgestimate and ethinyl estradiol tablets), generic versions of Johnson & Johnson's Ortho Cyclen and Ortho Tri-Cyclen, respectively. Sandoz said the launches brought the total number of oral contraceptives it has launched since the beginning of 2011 to six.

March 20, 2013
Teva appoints former Dyax executive

Teva Pharmaceutical Industries has appointed a former executive from Dyax to its executive team, the Israeli generic drug maker said.

JERUSALEM — Teva Pharmaceutical Industries has appointed a former executive from Dyax to its executive team, the Israeli generic drug maker said.

Teva announced the appointment of Ivana Magovčević-Liebisch as SVP and head of corporate business development, effective April 1. Magovčević-Liebisch served as EVP and COO for Dyax, a Burlington, Mass.-based drug company.

March 19, 2013
FDA picks acting director for Office of Generic Drugs

The Food and Drug Administration has picked Kathleen Uhl to serve as acting director of the Office of Generic Drugs, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has picked Kathleen Uhl to serve as acting director of the Office of Generic Drugs, the agency said Tuesday.

In a memo sent out to staff of the Center for Drug Evaluation and Research, the section of the agency that oversees the OGD, CDER director Janet Woodcock wrote that Uhl most recently served as senior adviser to director Greg Geba, who announced his resignation Thursday.

March 19, 2013
GAO pushes FDA for final NDI guidance to improve enforcement efforts

The U.S. Government Accountability Office on Monday advised the Food and Drug Administration to establish a time frame on New Dietary Ingredient guidance, as well as guidance clarifying whether a liquid product may be labeled and marketed as a dietary supplement or as a conventional food with added ingredients.

WASHINGTON — The U.S. Government Accountability Office on Monday advised the Food and Drug Administration to establish a time frame on New Dietary Ingredient guidance, as well as guidance clarifying whether a liquid product may be labeled and marketed as a dietary supplement or as a conventional food with added ingredients. Those two guidelines will help the agency use adverse event reports in overseeing dietary supplement products, the GAO stated.

March 19, 2013
MTM message breaks through in Congress

Last week, I wrote about Medication Therapy Management and a new bill in the House of Representatives to expand the pool of patients who qualify for MTM programs through Medicare. This week, I’m writing about – wait for it – medication therapy management.

Why? Because MTM is important, vitally important, to the future of community pharmacy, and one of the key health and prevention services that will define the profession in the era of health reform and evidence-based health care.

Last week, I wrote about medication therapy management and a new bill in the House of Representatives to expand the pool of patients who qualify for MTM programs through Medicare. This week, I’m writing about — wait for it — medication therapy management.

March 19, 2013
Supreme Court to hear generic drug liability case

The question of whether a generic drug company can be held liable for harmful side effects from its medicines goes before the Supreme Court Tuesday in a case involving a New Hampshire woman who sustained several injuries after taking a generic pain drug.

WASHINGTON — The question of whether a generic drug company can be held liable for harmful side effects from its medicines goes before the Supreme Court Tuesday in a case involving a New Hampshire woman who sustained several injuries after taking a generic pain drug.

March 19, 2013
WAG Q2 results headed in right direction as chain prepares three new flagship openings in DC, NY and Boston

Even as Walgreens expands its operation globally through strategic partnerships with both Alliance Boots and now AmerisourceBergen, the pharmacy operator continues to create some retail pop in the U.S. market.

DEERFIELD, Ill. — Even as Walgreens expands its operation globally through strategic partnerships with both Alliance Boots and now AmerisourceBergen, the pharmacy operator continues to create some retail pop in the U.S. market. For example, Walgreens has set the stage for the opening of three more flagship stores.

March 19, 2013
Walgreens, Alliance Boots announce blockbuster partnership with AmerisourceBergen

Walgreens will no longer source branded prescription medicines directly from suppliers beginning in September, the Chicago-based retailer announced as part of a significant partnership between Walgreens, Alliance Boots and AmerisourceBergen that includes Walgreens and Alliance Boots potentially taking a 7% stake in the Pennsylvania wholesaler.

DEERFIELD, Ill. — Walgreens will no longer source branded prescription medicines directly from suppliers beginning in September, the Chicago-based retailer announced Tuesday as part of a significant partnership between Walgreens, Alliance Boots and AmerisourceBergen that includes Walgreens and Alliance Boots potentially taking a 7% stake in the Pennsylvania wholesaler. Walgreens will begin sourcing generic medicines from AmerisourceBergen beginning in the calendar year 2014.  

March 18, 2013
FDA approves Mylan bronchospasm drug

The Food and Drug Administration has approved a generic treatment for bronchospasm made by Mylan, the drug maker said Monday.

PITTSBURGH — The Food and Drug Administration has approved a generic treatment for bronchospasm made by Mylan, the drug maker said Monday.

Mylan announced the approval of levalbuterol inhalation solution in the 0.31 mg/3 mL, 0.63 mg/3 mL and 1.25 mg/3 mL strengths. The company has begun shipping the product.

The drug is a generic version of Sunovion's Xopenex inhalation solution, which is used to treat bronchospasm in patients ages 6 years and older with reversible obstructive airway disease.

March 18, 2013
Perrigo launches store-brand guaifenesin 600-mg extended-release tablets

Perrigo announced that it has begun shipments of guaifenesin 600-mg extended-release tablets. It's the first product that is generically equivalent to Reckitt Benckiser's Mucinex 600-mg extended-release tablets.

ALLEGAN, Mich. — Perrigo on Monday announced that it has begun shipments of guaifenesin 600-mg extended-release tablets. It's the first product that is generically equivalent to Reckitt Benckiser's Mucinex 600-mg extended-release tablets. 

March 18, 2013
Walgreens demonstrates success on improving adherence at World Congress Summit

Walgreens recently presented the research on how community pharmacy programs, as well as new adherence models and metrics, can help drive better medication adherence.

DEERFIELD, Ill. — Walgreens recently presented the research on how community pharmacy programs, as well as new adherence models and metrics, can help drive better medication adherence. The research, presented at the World Congress Summit in Philadelphia last Friday, demonstrates the company’s success in improving patient medication adherence by developing an infrastructure that tracks patient-level adherence and uses predictive modeling along with risk stratification to identify patient patterns. 

March 15, 2013
FDA approves new packet version of AbbVie testosterone gel

The Food and Drug Administration has approved a new pocket-sized packet option for a testosterone-replacement therapy made by AbbVie, the drug maker said Friday.

CHICAGO — The Food and Drug Administration has approved a new pocket-sized packet option for a testosterone-replacement therapy made by AbbVie, the drug maker said Friday.

AbbVie announced the approval of the new version of AndroGel (testosterone) 1.62%, available in a packet containing 40.5 mg of testosterone in 2.5 g of gel and a packet with 20.25 mg of testosterone in 1.25 g of gel. The drug is used to raise testosterone levels in men with low or no testosterone, known as hypogonadism, estimated to affect nearly 14 million men in the United States.

March 15, 2013
Medbox buys stake in drug-vending company, forms jointly controlled corporation

Pharmaceutical vending machine maker Medbox has bought a 50% stake in a Michigan-based company that has developed an automated medicine dispensing machine, Medbox said Friday.

NEW YORK — Pharmaceutical vending machine maker Medbox has bought a 50% stake in a Michigan-based company that has developed an automated medicine dispensing machine, Medbox said Friday.

The $5.15 million deal with MedVend includes a $300,000 capital infusion and additional loans if needed for operating expenses into a jointly controlled new corporation that will also be called MedVend.

March 15, 2013
NCPA gets behind collective bargaining bill

The National Community Pharmacists Association endorsed H.R. 1188, legislation introduced by U.S. Reps. Tom Marino, R-Pa., and Judy Chu, D-Calif., that would allow independent community pharmacies to collectively negotiate.

ALEXANDRIA, Va. — The National Community Pharmacists Association on Friday endorsed H.R. 1188, legislation introduced by U.S. Reps. Tom Marino, R-Pa., and Judy Chu, D-Calif. The bill will allow independent community pharmacies to collectively negotiate the terms and conditions of insurance contracts they must sign, typically with pharmacy benefit managers that administer prescription drug plans. 

March 15, 2013
PharmaSmart kiosks validated in two independent studies, new clinical integration announced

PharmaSmart International’s comprehensive blood pressure program has recently been validated in two new, independent scientific studies, the company announced today. The company also announced a partnership with Rx-30 Pharmacy System that offers an automated clinical integration of validated PharmaSmart biometrics within the patient record.

ROCHESTER, N.Y. — PharmaSmart International’s comprehensive blood pressure program has recently been validated in two new, independent scientific studies, the company announced today. The company also announced a partnership with Rx-30 Pharmacy System that offers an automated clinical integration of validated PharmaSmart biometrics within the patient record.

March 14, 2013
FDA approves Par generic obsessive compulsive disorder drug

The Food and Drug Administration has approved a drug for obsessive compulsive disorder made by Par Pharmaceutical Cos., the drug maker said Thursday.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a drug for obsessive compulsive disorder made by Par Pharmaceutical Cos., the drug maker said Thursday.

Par announced the approval and shipment of fluvoxamine maleate extended-release capsules in the 100-mg and 150-mg strengths. The drug is a generic version of Jazz Pharmaceuticals' Luvox CR.

March 14, 2013
FDA to review experimental opioid drug

The Food and Drug Administration will decide in late August whether to approve an experimental opioid painkiller made by QRxPharma, the drug maker said Thursday.

BEDMINSTER, N.J. — The Food and Drug Administration will decide in late August whether to approve an experimental opioid painkiller made by QRxPharma, the drug maker said Thursday.

Australia-based QRxPharma is seeking approval for Moxduo (morphine and oxycodone), and the FDA plans to decide whether to approve the drug on Aug. 26.

March 14, 2013
Increasing use of generics would save money amid sequester, GPhA tells members of Congress

Amid a tide of automatic spending cuts resulting from the failure of Congress and the White House to agree on a budget, the generic drug lobby has offered some suggestions to generate savings.

WASHINGTON — Amid a tide of automatic spending cuts resulting from the failure of Congress and the White House to agree on a budget, the generic drug lobby has offered some suggestions to generate savings.

March 14, 2013
Mylan can launch generic diabetes drug in August

Mylan has settled a patent-infringement lawsuit filed by Shionogi over its generic version of a drug for diabetes, Mylan said.

PITTSBURGH — Mylan has settled a patent-infringement lawsuit filed by Shionogi over its generic version of a drug for diabetes, Mylan said.

The generic drug maker said that under the agreement, it can launch a generic version of Shionogi's Fortamet (metformin hydrochloride) extended-release tablets in the 500-mg and 1,000-mg strengths on Aug. 1.

Metformin hydrochloride extended-release tablets in those two strengths had sales of about $125 million during the 12-month period that ended in September, according to IMS Health.

 

March 14, 2013
Reports: FDA generic drug chief resigns

The director of the Food and Drug Administration's Office of Generic Drugs is stepping down, according to published reports.

NEW YORK — The director of the Food and Drug Administration's Office of Generic Drugs is stepping down, according to published reports.

Pharmalot, a blog run by journalist Ed Silverman, reported that Greg Geba is leaving the office over differences resulting from a recent reorganization, effective Friday.

March 14, 2013
SoloHealth named to Georgia’s list of Top 10 Innovative Technology Companies

SoloHealth on Thursday announced it has been selected as one of the Technology Association of Georgia’s Top 10 Innovative Technology Companies. SoloHealth was recognized for its FDA-approved health and wellness kiosk, the SoloHealth Station.

ATLANTA — SoloHealth on Thursday announced it has been selected as one of the Technology Association of Georgia’s Top 10 Innovative Technology Companies. SoloHealth was recognized for its FDA-approved health and wellness kiosk, the SoloHealth Station.

"The Top 10 awards are given to an elite group of companies whose products and solutions are not only changing their respective industries, they also are putting Georgia on the map as a state where technology innovation can thrive," stated Tino Mantella, president & CEO of TAG. 

March 13, 2013
PDX, CoverMyMeds partner on prior authorizations

Pharmacy-automation system maker PDX has made a deal with CoverMyMeds to help pharmacies using PDX's system to expedite the submission of prior-authorization forms to health insurance plans, PDX said.

COLUMBUS, Ohio — Pharmacy-automation system maker PDX has made a deal with CoverMyMeds to help pharmacies using PDX's system to expedite the submission of prior-authorization forms to health insurance plans, PDX said.

The service, which will be offered at no cost to pharmacies, is meant to decrease the administrative hassles of prior authorizations, improve turnaround time and help to stop prescription abandonment.

March 12, 2013
State, territorial attorneys general call for anti-tampering measures in opioids

The attorneys general of 46 states and two territories are calling on the Food and Drug Administration to make prescription painkillers harder to abuse.

NEW YORK — The attorneys general of 46 states and two territories are calling on the Food and Drug Administration to make prescription painkillers harder to abuse.