Content about Pharmaceutical sciences

May 6, 2013
FDA gives breakthrough therapy designation to experimental hepatitis C regimen

An experimental drug regimen under development by AbbVie could change the way hepatitis C is treated, according to a special designation it received from the Food and Drug Administration.

NORTH CHICAGO, Ill. — An experimental drug regimen under development by AbbVie could change the way hepatitis C is treated, according to a special designation it received from the Food and Drug Administration.

May 6, 2013
FDA Law Blog: Recent Plan B One Step approval may reignite simultaneous Rx-OTC debate

The Food and Drug Administration may soon find itself in another Plan-B-generated quandary — the complications around granting a three-year marketing exclusivity for a medicine that is both prescription-only and over-the-counter, according to an FDA Law Blog posted Sunday by Hyman, Phelps & McNamara.

WASHINGTON — The Food and Drug Administration may soon find itself in another Plan-B-generated quandary — the complications around granting a three-year marketing exclusivity for a medicine that is both prescription-only and over-the-counter, according to an FDA Law Blog posted Sunday by Hyman, Phelps & McNamara. 

May 6, 2013
Florida legislature passes biosimilar substitution bill

Florida's state legislature approved a bill last week that will allow pharmacists to substitute biosimilars for brand name biotech drugs.

NEW YORK — Florida's state legislature approved a bill last week that will allow pharmacists to substitute biosimilars for brand name biotech drugs.

The bill, which was approved last Tuesday and is scheduled to take effect on July 1, institutes requirements for pharmacists to substitute biosimilars when they are determined to be biosimilar to and interchangeable with the brand name product, while also requiring the state board of pharmacy to maintain a current list of interchangeable products.

May 6, 2013
Industry urges FDA to clarify new dietary ingredient notification regulations

The five associations representing the dietary supplement industry on Monday requested that the Food and Drug Administration issue revised guidance on new dietary ingredient notifications, with a specific focus on the information to be included to identify the new dietary ingredient.

SILVER SPRING, Md. — The five associations representing the dietary supplement industry on Monday requested that the Food and Drug Administration issue revised guidance on new dietary ingredient notifications, with a specific focus on the information to be included to identify the new dietary ingredient. 

May 6, 2013
New Jersey attorney general's office releases anticrime best practices for pharmacy

Retail pharmacies, drug makers and law enforcement have a variety of methods used to fight organized crime, and the New Jersey Office of the Attorney General has drawn up a list of best practices that pharmacies can use to keep stores, drugs, staff and customers safe.

NEW YORK — Retail pharmacies, drug makers and law enforcement have a variety of methods used to fight organized crime, and the New Jersey Office of the Attorney General has drawn up a list of best practices that pharmacies can use to keep stores, drugs, staff and customers safe.

May 3, 2013
Actavis sales up 24% in first quarter 2013

Actavis' had $1.9 billion in sales in first quarter 2013, the drug maker said.

PARSIPPANY, N.J. — Actavis' had $1.9 billion in sales in first quarter 2013, the drug maker said.

The latest figure represented a 24% increase from first quarter 2012's $1.52 billion. "The new Actavis is off to a strong start in 2013, and as a result, we are increasing our 2013 forecast based on the strong performance and execution against our objectives to date," president and CEO Paul Bisaro said.

May 3, 2013
Expansion of in-store health kiosks setting stage for pharmacy web of improved-outcome solutions

Kinney Drugs, with its almost-100 locations located primarily in upstate New York, is the latest pharmacy to capitalize on the robust offerings available through in-store health kiosks. Because it isn't only about taking that random blood pressure check anymore.

No, the in-store health kiosks going into stores today are designed to augment outcomes-based health care. For example, through the use of "smart cards," PharmaSmart helps track historical health metrics across its trademarked Blood Pressure Tracker web portal.

Kinney Drugs, with its almost-100 locations located primarily in upstate New York, is the latest pharmacy to capitalize on the robust offerings available through in-store health kiosks. Because it isn't only about taking that random blood pressure check anymore. 

May 3, 2013
NCPA lobbies Hawaii governor to sign two 'pharmacy-friendly' pieces of legislation

The National Community Pharmacists Association on Thursday urged Hawaii Gov. Neil Abercrombie to sign two bills into law that the association asserts will "protect patient pharmacy choice."

ALEXANDRIA, Va. — The National Community Pharmacists Association on Thursday urged Hawaii Gov.

May 2, 2013
Eli Lilly, Boehringer Ingelheim launch educational program for healthcare professionals

Drug makers Boehringer Ingelheim and Eli Lilly have started a campaign designed to educate healthcare professionals about the role a type of protein plays in maintaining blood-sugar balance.

INDIANAPOLIS — Drug makers Boehringer Ingelheim and Eli Lilly have started a campaign designed to educate healthcare professionals about the role a type of protein plays in maintaining blood-sugar balance.

BI and Lilly created the website sglt.com to inform users about the role of sodium glucose co-transporters. The program also includes a video, Glucose Perspectives, in the form of a sketch animation by the United Kingdom's Royal Society for the Encouragement of Arts, Manufactures and Commerce.

May 2, 2013
Justice Department appeals district court ruling removing emergency contraceptive sales restrictions

The Justice Department reported it will appeal a recent judicial decision that would require removing any age restriction from the purchase of the Plan B emergency contraceptive, according to a report published in USA Today.

WASHINGTON — The Justice Department late Wednesday reported it will appeal a recent judicial decision that would require removing any age restriction from the purchase of the Plan B emergency contraceptive, according to a report published in USA Today.

May 2, 2013
NACDS joins 'Partnership for Advancing Medication Adherence'

The National Association of Chain Drug Stores has announced its membership in “Prescriptions for a Healthy America: A Partnership for Advancing Medication Adherence."

ARLINGTON, Va. — The National Association of Chain Drug Stores has announced its membership in “Prescriptions for a Healthy America: A Partnership for Advancing Medication Adherence."

May 2, 2013
Rite Aid comps decrease amid earlier Easter, new generics

Rite Aid's same-store sales decreased 4% in April compared with April 2012 due to an earlier Easter and introductions of new generic drugs, the retail pharmacy chain said.

CAMP HILL, Pa. — Rite Aid's same-store sales decreased 4% in April compared with April 2012 due to an earlier Easter and introductions of new generic drugs, the retail pharmacy chain said Thursday.

The numbers released Thursday included a 3.5% decrease in sales on the front end and a 4.2% decrease in pharmacy sales, but the pharmacy figure included a 4.54% negative effect due to new generics. Same-store prescription count decreased by 0.2%.

Total sales for the month were $1.902 billion, a 4.6% decrease over April 2012's $1.993 billion.

May 1, 2013
FDA approves Plan B One-Step front-end placement for females 15 and older

The Food and Drug Administration announced that it has approved an amended application submitted by Teva Women’s Health to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years and older.

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday announced that it has approved an amended application submitted by Teva Women’s Health to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years and older. The approval will move Plan B from behind the pharmacy counter into the family planning set of the pharmacy. 

May 1, 2013
Teva introduces generic bronchospasm drug

Teva Pharmaceutical Industries has launched a generic inhaler used to treat bronchospasm, the company said.

NORTH WALES, Pa. — Teva Pharmaceutical Industries has launched a generic inhaler used to treat bronchospasm, the company said.

Teva announced the introduction of levalbuterol inhalation solution. The product is a generic version of Sunovion's Xopenex and is available in the 0.31 mg, 0.63 mg and 1.25 mg strengths.

Various versions of the drug had sales of $438.8 million in 2012, according to IMS Health.

April 30, 2013
Aurobindo receives FDA approval for hypertension, antibiotic drugs

The Food and Drug Administration has approved two generic drugs made by Aurobindo Pharma, the drug maker said.

HYDERABAD — The Food and Drug Administration has approved two generic drugs made by Aurobindo Pharma, the drug maker said.

The company announced Tuesday the approval of quinapril tablets in the 5-mg, 10-mg, 20-mg and 40-mg strengths. The drug is a generic version of Pfizer's Accupril and is used to treat high blood pressure. Various versions of the drug had sales of about $49 million during the 12-month period ending in September, according to IMS Health.

April 30, 2013
Drug for rare, fatal genetic disorder receives FDA approval

The Food and Drug Administration has approved a new treatment for a genetic disorder that affects about 500 people in the United States and 3,000 worldwide, the agency said Tuesday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for a genetic disorder that affects about 500 people in the United States and 3,000 worldwide, the agency said Tuesday.

April 30, 2013
FDA approves anticoagulant-reversal product

The Food and Drug Administration has approved a drug that reverses the effects of anticoagulant drugs in patients who have suffered acute major bleeding, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug that reverses the effects of anticoagulant drugs in patients who have suffered acute major bleeding, the agency said.

The FDA announced the approval of CSL Behring's Kcentra (prothrombin complex concentrate [human]) for the urgent reversal of vitamin K antagonist, or VKA drugs such as warfarin.

April 30, 2013
FDA approves Genentech arthritis drug for rare disorder in children

The Food and Drug Administration has approved a drug made by Genentech for a rare form of arthritis in children, the company said Tuesday.

SOUTH SAN FRANCISCO, Calif. — The Food and Drug Administration has approved a drug made by Genentech for a rare form of arthritis in children, the company said Tuesday.

Genentech, a subsidiary of Swiss drug maker Roche, announced the approval of Actemra (tocilizumab) for polyarticular juvenile idiopathic arthritis in children ages 2 years and older, either alone or combined with the generic drug methotrexate.

April 30, 2013
FDA delays approval of Gilead HIV drugs

The Food and Drug Administration declined to approve two drugs for HIV made by Gilead Sciences for which the company was seeking approval for use as part of treatment regimens.

FOSTER CITY, Calif. — The Food and Drug Administration declined to approve two drugs for HIV made by Gilead Sciences for which the company was seeking approval for use as part of treatment regimens.

April 29, 2013
FDA appoints Mary Beth Clarke as director of Office of Executive Programs

A Food and Drug Administration staffer who has led implementation of the Generic Drug User Fee Act has been named to a new director position at the agency, the FDA said Monday.

SILVER SPRING, Md. — A Food and Drug Administration staffer who has led implementation of the Generic Drug User Fee Act has been named to a new director position at the agency, the FDA said Monday.

The FDA announced that it had appointed Mary Beth Clarke as permanent director of the Office of Executive Programs. Clarke had previously served as the OEP's executive director.

April 26, 2013
Actavis can launch generic OxyContin in January 2014 under settlement with Purdue

Generic drug maker Actavis is settling a patent-infringement suit with Purdue Pharma concerning the opioid painkiller OxyContin, Actavis said, saying it expected to make more than $100 million in the deal between 2014 and 2015.

PARSIPPANY, N.J. — Generic drug maker Actavis is settling a patent-infringement suit with Purdue Pharma concerning the opioid painkiller OxyContin, Actavis said Friday, saying it expected to make more than $100 million in the deal between 2014 and 2015.

April 26, 2013
CVS Caremark stresses proper management, disposal of meds in light of study on teen Rx abuse

With National Drug Take Back Day scheduled for April 27 and in light of a new national study revealing that 1-out-of-4 teenagers has misused or abused a prescription medication at least once, CVS Caremark is reminding families that proper management, storage and disposal of their medication can reduce access to drugs by young people in their homes.

WOONSOCKET, R.I. — With National Drug Take Back Day scheduled for April 27 and in light of a new national study revealing that 1-out-of-4 teenagers has misused or abused a prescription medication at least once, CVS Caremark is reminding families that proper management, storage and disposal of their medication can reduce access to drugs by young people in their homes.

April 26, 2013
Mallinckrodt collects unused medications in St. Louis

Medical products manufacturer Covidien's pharmaceutical division is expanding an initiative to collect unused and unwanted medications.

ST. LOUIS — Medical products manufacturer Covidien's pharmaceutical division is expanding an initiative to collect unused and unwanted medications.

Mallinckrodt said it would expand communities' access to drug take-back collection boxes and promote safe disposal practices, installing lock boxes in three police stations around St. Louis. The company said it purchased the boxes under a collaboration with the National Association of Drug Diversion Investigators and also would provide a grant to help incinerate the medications that are collected.

April 26, 2013
Obama administration hopes to tackle prescription drug abuse

More than 1.3 million emergency room visits in 2010 were related to abuse of prescription drugs, and the problem has become widespread enough that the Centers for Disease Control and Prevention classifies it as an epidemic. In response, curbing abuse of prescription drugs has become a cornerstone of the Obama administration's drug policy.

WASHINGTON — More than 1.3 million emergency room visits in 2010 were related to abuse of prescription drugs, and the problem has become widespread enough that the Centers for Disease Control and Prevention classifies it as an epidemic. In response, curbing abuse of prescription drugs has become a cornerstone of the Obama administration's drug policy.

April 26, 2013
Pharmaceutical distribution agreements critical for Cardinal, McKesson

Cardinal Health announced the renewal of its pharmaceutical distribution agreement with CVS Caremark to supply pharmaceuticals to the company’s retail pharmacies and distribution centers, as McKesson, which generally serves the PBM side of the business, also announced the renewal of its current distribution agreement with the pharmacy retailer.

The renewal of the agreements was not only critical for both companies but, as Adam Fein, president of Pembroke Consulting and CEO of Drug Channels Institute, wrote in his blog “CVS Caremark Renews with Cardinal and McKesson,” it also “demonstrates wholesalers' value in the brand-name pharmacy supply chain.”

Cardinal Health announced the renewal of its pharmaceutical distribution agreement with CVS Caremark to supply pharmaceuticals to the company’s retail pharmacies and distribution centers, as McKesson, which generally serves the PBM side of the business, also announced the renewal of its current distribution agreement with the pharmacy retailer.