Content about Pharmaceutical sciences

February 28, 2014

Lupin announced that it received approval from the Food and Drug Administration for rifabutin capsules USP, 150-mg, a generic version of Pharmacia and Upjohn Company's Mycobutin capsules.

MUMBAI and BALTIMORE — Lupin on Wednesday announced that it received approval from the Food and Drug Administration for rifabutin capsules USP, 150 mg — a generic version of Pharmacia and Upjohn Company's Mycobutin capsules. The company's U.S. subsidiary will begin marketing the product soon.

The drug is used for the prevention of disseminated Mycobacterium avium complex disease in patients with advanced HIV infection. Mycobutin capsules had annual sales of $18.6 million in the United States, according to IMS MAT.

 

February 26, 2014

A pair of Food and Drug Administration advisory committees on Tuesday voted against the over-the-counter sale of Armstrong Pharmaceuticals' Primatene HFA, an epinephrine inhalation aerosol indicated for the temporary relief of mild symptoms of intermittent asthma for people ages 12 years or older.

SILVER SPRING, Md. — A pair of Food and Drug Administration advisory committees on Tuesday voted against the over-the-counter sale of Armstrong Pharmaceuticals' Primatene HFA, an epinephrine inhalation aerosol indicated for the temporary relief of mild symptoms of intermittent asthma for people ages 12 years or older.

February 25, 2014

The Drug Enforcement Administration's Atlanta Field Division last week announced the launch of an anonymous statewide prescription drug texting tip line available to the public.

ATLANTA — The Drug Enforcement Administration's Atlanta Field Division last week announced the launch of an anonymous statewide prescription drug texting tip line available to the public. 

February 25, 2014

The Food and Drug Administration has approved Myalept (metreleptin for injection) to treat complications of leptin deficiency in patients with congenital generalized or acquired generalized lipodystrophy, a condition associated with a lack of fat tissue.

SILVER SPRING, Md. — The Food and Drug Administration has approved Myalept (metreleptin for injection) to treat complications of leptin deficiency in patients with congenital generalized or acquired generalized lipodystrophy, which is a condition associated with a lack of fat tissue.

February 25, 2014

U.S. House of Representatives Energy and Commerce Committee vice chair Marsha Blackburn, R-Tenn., and Rep. Tom Marino, R-Pa., have introduced legislation that would establish a work group to explore opportunities to reduce prescription drug abuse without compromising access to medications for patients who legitimately need them.

ARLINGTON, Va. — U.S. House of Representatives Energy and Commerce Committee vice chair Marsha Blackburn, R-Tenn., and Rep. Tom Marino, R-Pa., have introduced legislation that would establish a work group to explore opportunities to reduce prescription drug abuse without compromising access to medications for patients who legitimately need them.

The National Association of Chain Drug Stores on Tuesday expressed its support for the new legislation — the Ensuring Patient Access and Effective Drug Enforcement Act of 2013 (H.R. 4069).

February 25, 2014

As part of the National Governors Association’s ongoing effort to help states reduce prescription drug abuse, findings from the Prescription Drug Abuse Reduction Policy Academy were the focus of the Health and Human Services Committee session at NGA’s 2014 Winter Meeting, the association announced Sunday.

WASHINGTON — As part of the National Governors Association’s ongoing effort to help states reduce prescription drug abuse, findings from the Prescription Drug Abuse Reduction Policy Academy were the focus of the Health and Human Services Committee session at NGA’s 2014 Winter Meeting, the association announced Sunday. 

February 25, 2014

SpartanNash on Tuesday announced the formation of a partnership to offer a comprehensive mobile and web pharmacy solution to SpartanNash customers.

GRAND RAPIDS, Mich. — SpartanNash on Tuesday announced the formation of a partnership to offer a comprehensive mobile and web pharmacy solution to SpartanNash customers. The mobile solution, powered by mscripts, will enable SpartanNash customers to refill prescriptions, receive pickup and dosage reminders, and manage accounts for their family members. 

SpartanNash operates 88 pharmacies in six states throughout the upper Midwest.

February 25, 2014

UC-San Francisco and Walgreens on Tuesday opened a Walgreens store on the UCSF campus that aims to improve medication safety, decrease healthcare costs and help patients use medicines more effectively by offering pharmacist-based patient care and expanded health-and-wellness services to the community.

SAN FRANCISCO — UC-San Francisco and Walgreens on Tuesday opened a Walgreens store on the UCSF campus that aims to improve medication safety, decrease healthcare costs and help patients use medicines more effectively by offering pharmacist-based patient care and expanded health-and-wellness services to the community. A joint effort among Walgreens, the UCSF School of Pharmacy and UCSF Medical Center, “Walgreens at UCSF” also will explore new models for improving overall patient care.

February 21, 2014

Food and Drug Administration Office of Generic Drugs' acting director Kathleen Uhl highlighted the industry and FDA’s shared commitment to Generic Drug User Fee Act milestones and approaching metrics in her keynote address at the GPhA Annual Meeting taking place here.

ORLANDO, Fla. — Food and Drug Administration Office of Generic Drugs' acting director Kathleen Uhl on Thursday highlighted the industry and FDA’s shared commitment to Generic Drug User Fee Act milestones and approaching metrics in her keynote address at the GPhA Annual Meeting taking place here.

February 21, 2014

The Food and Drug Administration will host a public meeting in March to discuss updating the OTC monograph system, the Wall Street Journal reported Friday.

SILVER SPRING, Md. — The Food and Drug Administration will host a public meeting in March to discuss updating the OTC monograph system, the Wall Street Journal reported Friday

According to the report, the FDA will consider improving the agency's ability to initiate label changes quickly, allowing for faster innovation from manufacturers and imposing new pediatric dosing limits based on the most recent science. 

February 20, 2014

The Generic Pharmaceutical Association on Wednesday announced that Craig Wheeler, president and CEO, Momenta Pharmaceuticals, was elected as GPhA board chairman.

ORLANDO, Fla. — The Generic Pharmaceutical Association on Wednesday announced that Craig Wheeler, president and CEO, Momenta Pharmaceuticals, was elected as GPhA board chairman. Wheeler succeeds Tony Mauro, president, Mylan North America. 

February 20, 2014

How retail pharmacies invest in technology and harness the flood of patient and drug utilization data it generates will determine, in large part, the future of the profession and its relevance to a fast-changing health system seeking new cost-saving solutions and more effective approaches to patient care and disease prevention.

Where is pharmacy technology headed, and how will it be put to use by pharmacists and the companies that employ them?

February 19, 2014

Tricare for Life beneficiaries soon will receive letters guiding them to Tricare Pharmacy Home Delivery or a military pharmacy for some prescriptions as part of a congressionally mandated pilot program, officials of the military healthcare plan reported Tuesday.

FALLS CHURCH, Va. — Tricare for Life beneficiaries soon will receive letters guiding them to Tricare Pharmacy Home Delivery or a military pharmacy for some prescriptions as part of a congressionally mandated pilot program, officials of the military healthcare plan reported Tuesday.

Tricare for Life is secondary coverage for Tricare beneficiaries who have both Medicare Parts A and B in the United States and U.S. territories.

February 19, 2014

The Food and Drug Administration announced that it has approved Northera capsules (droxidopa) for the treatment of neurogenic orthostatic hypotension.

SILVER SPRING, Md. — The Food and Drug Administration announced that it has approved Northera capsules (droxidopa) for the treatment of neurogenic orthostatic hypotension.

NOH is a rare, chronic drop in blood pressure upon standing that's associated with Parkinson's disease, multiple-system atrophy and pure autonomic failure. Symptoms include dizziness, lightheadedness, blurred vision, fatigue and fainting when a person stands.

February 19, 2014

The Food and Drug Administration announced the initiation of the Secure Supply Chain Pilot Program to enhance the security of imported drugs.

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday announced the initiation of the Secure Supply Chain Pilot Program to enhance the security of imported drugs. 

In August 2013, the FDA published a notice in the Federal Register (78 FR 51192) to solicit companies to voluntarily submit applications for participation in this two-year program. Thirteen prequalified companies have now been designated to take part, and will receive expedited entry for the importation of up to five selected drug products into the United States.

February 19, 2014

Legislation recently introduced by U.S. Rep. Tom Marino, R-Pa., which is intended to reduce the abuse of prescription drugs by fostering greater collaboration among stakeholders and implementing new safeguards, has received the endorsement of the National Community Pharmacists Association.

ALEXANDRIA, Va. — Legislation recently introduced by U.S. Rep. Tom Marino, R-Pa., which is intended to reduce the abuse of prescription drugs by fostering greater collaboration among stakeholders and implementing new safeguards, has received the endorsement of the National Community Pharmacists Association.

February 19, 2014

The results of the 2013 BPS specialty certification and recertification exams were announced Tuesday by the Board of Pharmacy Specialties, the post-licensure certification organization serving the pharmacy profession.

WASHINGTON — The results of the 2013 BPS specialty certification and recertification exams were announced Tuesday by the Board of Pharmacy Specialties, the post-licensure certification organization serving the pharmacy profession.   

February 19, 2014

The West Virginia Senate on Tuesday voted 25-to-9 to make pseudoephedrine a Schedule IV prescription drug and exempt medicines that can’t easily be diverted to methamphetamine, according to published reports.

CHARLESTON, W.Va. — The West Virginia Senate on Tuesday voted 25-to-9 to make pseudoephedrine a Schedule IV prescription drug and exempt medicines that can’t easily be diverted to methamphetamine, according to published reports. A similar bill is being considered by the West Virginia House of Delegates.

According to reports, the two exceptions to the prescription-only requirement would include Acura Pharmaceuticals' Nexafed and Westport Pharmaceuticals' Zephrex-D. 

February 18, 2014

Recent strategic business initiatives are granting wholesalers more generic drug purchasing power than ever before.

Recent strategic business initiatives are granting wholesalers more generic drug purchasing power than ever before.

Over the last few years, some major deals in the world of drug wholesaling have taken shape. While the business arrangements among the three top wholesalers differ slightly in terms of ownership, benefits and risks, one thing is for certain: all of the agreements will translate into growth opportunities for the companies involved and will help them improve their generic drug sourcing practices.

February 18, 2014

In a blog post updated Friday, Food and Drug Administration commissioner Margaret Hamburg addressed two challenges facing Indian drug manufacturers — approval times for abbreviated new drug applications and quality inspections.

SILVER SPRING, Md. — In a blog post updated Friday, Food and Drug Administration commissioner Margaret Hamburg addressed two challenges facing Indian drug manufacturers — approval times for abbreviated new drug applications and quality inspections. 

February 18, 2014

From 2012 to 2017, global spending on medicines will increase from $205 billion to $235 billion, according to IMS Health. By 2017, 36% of the spend will be on generics, a number that is 9% more than the percentage in 2013.

From 2012 to 2017, global spending on medicines will increase from $205 billion to $235 billion, according to IMS Health. By 2017, 36% of the spend will be on generics, a number that is 9% more than the percentage in 2013.

As a result of the patent cliff, generic drug manufacturers have thrived while branded pharmaceutical manufacturers have suffered. Branded pharmaceutical manufacturers are expected to suffer even more in the coming years, as many more important patents will lose exclusivity.

February 18, 2014

The federal agency in charge of Medicare is pushing for a major overhaul of its Medicare Part D drug benefit program for seniors.

The federal agency in charge of Medicare is pushing for a major overhaul of its Medicare Part D drug benefit program for seniors. Those changes, if adopted, could help level the competitive playing field for pharmacy retailers in Part D plan networks, reduce competitive advantages for preferred pharmacy networks and mail-order pharmacies, and put a tighter squeeze on pharmacy benefit managers.

Thus, the proposals by the Centers for Medicare and Medicaid Services for the 2015 federal fiscal year could spell big changes for retail pharmacies. Among the most far-reaching are:

February 18, 2014

To put it in Facebook terms, the pharmaceutical industry by and large has yet to friend American consumers.

To put it in Facebook terms, the pharmaceutical industry by and large has yet to friend American consumers.

A new report from the IMS Institute for Healthcare Informatics concludes that fewer than half of the top 50 global pharmaceutical manufacturers “have some level of healthcare social media engagement.” This, despite the fact that “increasingly, patients are turning to social media as an essential forum for obtaining and sharing information related to their health,” noted Murray Aitken, the institute’s executive director.

February 18, 2014

Where is pharmacy automation headed, and how will it be put to use by pharmacists and the companies that employ them?

Where is pharmacy automation headed, and how will it be put to use by pharmacists and the companies that employ them?

February 14, 2014

Global public health organization NSF International has launched the NSF Cosmetics and Personal Care Program to provide auditing, training, product testing, claim substantiation and certification services to enable manufacturers to improve the quality and safety of their products, and retailers to strengthen the oversight of their cosmetic and personal care suppliers, the organization announced on Friday.

ANN ARBOR, Mich. — Global public health organization NSF International has launched the NSF Cosmetics and Personal Care Program to provide auditing, training, product testing, claim substantiation and certification services to enable manufacturers to improve the quality and safety of their products, and retailers to strengthen the oversight of their cosmetic and personal care suppliers, the organization announced on Friday.