Content about Generics

June 25, 2012

The Food and Drug Administration has approved a generic drug for attention deficit hyperactivity disorder made by Actavis, the drug maker said Monday.

MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic drug for attention deficit hyperactivity disorder made by Actavis, the drug maker said Monday.

Actavis, whose parent company was recently acquired by Watson Pharmaceuticals, announced the approval of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, also known as mixed-amphetamine salts ER capsules.

June 25, 2012

A federal court has ruled against Mylan in a case filed by Teva Pharmaceutical Industries over a drug to treat multiple sclerosis.

PITTSBURGH — A federal court has ruled against Mylan in a case filed by Teva Pharmaceutical Industries over a drug to treat multiple sclerosis.

The U.S. District Court for the Southern District of New York ruled Monday that Mylan's proposed generic version of the drug Copaxone (glatiramer acetate) infringed Teva's patents.

Mylan responded that it was "disappointed" by the decision and would appeal once it had the opportunity to review it in full.

June 25, 2012

Teva has launched a generic version of an Eli Lilly drug.

JERUSALEM — Teva has launched a generic version of an Eli Lilly drug.

The drug maker said it has launched olanzapine and fluoxetine capsules in the 6-mg/25-mg, 12-mg/25-mg, 6-mg/50-mg, and 12-mg/50-mg strengths. The drug is a generic version of Symbyax, an acute treatment of treatment-resistant depression and bipolar I depression in adults.

Symbyax had annual sales of approximately $82 million in the United States, according to on IMS sales data.

June 21, 2012

Taken together, asthma and chronic obstructive pulmonary disease — which includes chronic bronchitis and emphysema — affect nearly 50 million Americans, or about 15% of the total U.S. population, according to statistics from such organizations as the Centers for Disease Control and Prevention.

Taken together, asthma and chronic obstructive pulmonary disease — which includes chronic bronchitis and emphysema — affect nearly 50 million Americans, or about 15% of the total U.S. population, according to statistics from such organizations as the Centers for Disease Control and Prevention. And combined, the two diseases cause more than 100,000 deaths per year. Fortunately, however, there is a wide range of treatments available for both, many of which work for both diseases.


June 21, 2012

While the picture of a new Rx-to-OTC switch paradigm is being painted with a broad stroke brush, already there are two divergent pathways emerging around what that new paradigm landscape might look like. 


While the picture of a new Rx-to-OTC switch paradigm is being painted with a broad stroke brush, already there are two divergent pathways emerging around what that new paradigm landscape might look like. 


OTC manufacturers have been framing the new paradigm within the existing two-drug-class system, suggesting that the diagnostic tools that already are available in the marketplace significantly could help expand which medicines are considered appropriate in the OTC space.


Retail pharmacists, on the other hand, are advocating for the creation of a third class of drugs.


June 21, 2012

Drug Store News recently talked with COPD Foundation founder and president John Walsh about the organization’s new leadership. In March, the COPD Foundation took over leadership for Drive4COPD, which aims to screen people for chronic obstructive pulmonary disease, a collective term for emphysema and chronic bronchitis, which the group estimates to affect 24 million Americans who may have it but don’t know it.


Drug Store News recently talked with COPD Foundation founder and president John Walsh about the organization’s new leadership. In March, the COPD Foundation took over leadership for Drive4COPD, which aims to screen people for chronic obstructive pulmonary disease, a collective term for emphysema and chronic bronchitis, which the group estimates to affect 24 million Americans who may have it but don’t know it.


DSN: What led the COPD Foundation to take over Drive4COPD?


June 21, 2012

Legislation proposed in the House of Representatives would speed up Food and Drug Administration approval of knock-off versions of vaccines and other biologics while requiring the agency to conduct more inspections of drug factories overseas, according to published reports.

WASHINGTON — Legislation proposed in the House of Representatives would speed up Food and Drug Administration approval of knock-off versions of vaccines and other biologics while requiring the agency to conduct more inspections of drug factories overseas, according to published reports.

June 21, 2012

The Food and Drug Administration has approved a branded acne drug made by Ranbaxy Labs, the drug maker said. Ranbaxy announced the FDA approval of Absorica (isotretinoin), a drug for treating severe recalcitrant nodular acne.

The Food and Drug Administration has approved a branded acne drug made by Ranbaxy Labs, the drug maker said. Ranbaxy announced the FDA approval of Absorica (isotretinoin), a drug for treating severe recalcitrant nodular acne. The company expects to launch it in the United States in fourth quarter 2012 under an agreement with Canada-based Cipher Pharmaceuticals.


June 21, 2012

Faced with the possibility of a critical cutoff in funding for the Food and Drug Administration, Congress moved in late May to reauthorize the Prescription Drug User Fee Act that provides the bulk of the agency’s resources for new-drug review and approval. 


Faced with the possibility of a critical cutoff in funding for the Food and Drug Administration, Congress moved in late May to reauthorize the Prescription Drug User Fee Act that provides the bulk of the agency’s resources for new-drug review and approval. 


June 21, 2012

Specialty and biologically engineered medicines have been a boon to millions of Americans with life-threatening and life-altering conditions. But their lofty prices are squeezing patients and payers and spawning a growing legislative backlash that threatens insurers and employer-based health plans.

Specialty and biologically engineered medicines have been a boon to millions of Americans with life-threatening and life-altering conditions. But their lofty prices are squeezing patients and payers and spawning a growing legislative backlash that threatens insurers and employer-based health plans.

“The imperative to find cost-effective alternatives to biologics reflects the growing demand for these specialty drugs,” IMS Health noted. “Since their origins in the 1980s, biologics have prospered into a U.S. $138 billion market [in 2010].”

June 21, 2012

In 2008, an investigation by the Associated Press revealed that drinking water supplies in major cities and metropolitan regions across the country are riddled with pharmaceutical compounds.

In 2008, an investigation by the Associated Press revealed that drinking water supplies in major cities and metropolitan regions across the country are riddled with pharmaceutical compounds. For 41 million Americans, it suggests water with something extra means more than just a slice of lemon, though the quantities of pharmaceutical compounds in the water are too small to constitute a medical dose, according to the report.


June 20, 2012

Hamacher Resource Group on Tuesday announced it will present “Marketing Diabetes in the Retail Setting” June 21 at the Marketing Diabetes Prevention and Awareness Conference in Atlanta.

WAUKESHA, Wis. — Hamacher Resource Group on Tuesday announced it will present “Marketing Diabetes in the Retail Setting” June 21 at the Marketing Diabetes Prevention and Awareness Conference in Atlanta.

Dave Wendland, VP and part of the owners group at HRG, will share ideas about how retail pharmacies can collaborate with suppliers to bring innovation to the diabetes care category to better serve patients, capture incremental sales and significantly grow the category’s reach.

June 20, 2012

Pharmacy customers who use the Mscripts application to order, refill and manage their prescriptions now can do so in English or Spanish, the company announced Wednesday.

SAN FRANCISCO — Pharmacy customers who use the Mscripts application to order, refill and manage their prescriptions now can do so in English or Spanish, the company announced Wednesday. They also can receive reminders to take their medications, making it easier to remain adherent to prescribed medication regimes.

Mscripts supports the mobile offerings of large pharmacy chains across the country.

June 19, 2012

The U.S. Court of Appeals for the Federal Circuit ruled in favor of Watson Pharmaceuticals during patent litigation concerning the drug maker's abbreviated new drug application for an overactive bladder treatment.

PARSIPPANY, N.J. — The U.S. Court of Appeals for the Federal Circuit ruled in favor of Watson Pharmaceuticals during patent litigation concerning the drug maker's abbreviated new drug application for an overactive bladder treatment.

The appeals court affirmed a U.S. District Court for the District of Delaware's decision — made March 31 — that asserted that patents related to Allergan's Sanctura XR (trospium chloride extended-release capsules) are invalid. Watson's ANDA for a generic version of Sanctura XR is pending with the Food and Drug Administration.

June 19, 2012

Maxim Health Systems now is a certified distributor of the Citi Flu Care card, the healthcare group announced Tuesday.

NEW YORK — Maxim Health Systems now is a certified distributor of the Citi Flu Care card, the healthcare group announced Tuesday.

June 19, 2012

Mylan's Canadian subsidiary has launched a new website that is designed to help Canadians learn more about the value, reliability and quality of generic pharmaceuticals.

PITTSBURGH — Mylan's Canadian subsidiary has launched a new website that is designed to help Canadians learn more about the value, reliability and quality of generic pharmaceuticals.

June 18, 2012

Merck announced that the U.S. District Court for the District of New Jersey ruled against the company in a patent infringement suit against Canada-based drug maker Apotex.

WHITEHOUSE STATION, N.J. — Merck announced that the U.S. District Court for the District of New Jersey ruled against the company in a patent infringement suit against Canada-based drug maker Apotex.

June 18, 2012

Greenstone, the generic pharmaceutical subsidiary of Pfizer, has launched olanzapine tablets.

PEAPACK, N.J. — Greenstone, the generic pharmaceutical subsidiary of Pfizer, has launched olanzapine tablets.

The drug, which is a generic version of Zyprexa — an Eli Lilly drug used to treat psychiatric disorders — in the 2.5-mg, 5-mg, 7.5-mg, 10-mg, 15-mg and 20-mg strengths.

Generic and branded versions of the drug had sales of about $3.28 billion during the 12-month period ended in January, according to IMS Health.

June 14, 2012

A new Walgreens study released Thursday found that a pharmacist-led training and counseling program for patients receiving an injectable diabetes medication improved medication adherence by 24%.

DEERFIELD, Ill. — A new Walgreens study released Thursday found that a pharmacist-led training and counseling program for patients receiving an injectable diabetes medication improved medication adherence by 24%.

June 13, 2012

As health departments across the country report record numbers of pertussis cases, the results of a new survey of American adults released Wednesday revealed that most parents aren't asking adults close to their infants and young children to get an adult whooping cough booster vaccine, even though they do ask them to follow other basic precautions to safeguard their children's health.

SWIFTWATER, Pa. — As health departments across the country report record numbers of pertussis cases, the results of a new survey of American adults released today reveal that most parents aren't asking adults close to their infants and young children to get an adult whooping cough booster vaccine, even though they do ask them to follow other basic precautions to safeguard their children's health.

June 12, 2012

The 2011-2012 influenza season was one of the mildest and latest seasons on record, according to a report from the Centers for Disease Control and Prevention.

ATLANTA — The 2011-2012 influenza season was one of the mildest and latest seasons on record, according to a report from the Centers for Disease Control and Prevention.

The peak percentage of outpatient visits for influenza-like illnesses of 2.4% was the lowest reported since the system began in its current format in 1997. The peak percentage of visits for ILI during those 14 seasons ranged from 3.2% for the 2002-2003 season to 7.7% during the 2009 H1N1 pandemic.

June 12, 2012

The Healthcare Distribution Management Association on Tuesday honored 10 pharmaceutical and consumer product manufacturers through the presentation of its annual Distribution Management Awards for Notable Achievements in Healthcare, or DIANA. The winners were announced Monday evening at the Association’s 2012 Business and Leadership Conference in San Antonio, Texas.

ARLINGTON, Va. — The Healthcare Distribution Management Association on Tuesday honored 10 pharmaceutical and consumer product manufacturers through the presentation of its annual Distribution Management Awards for Notable Achievements in Healthcare, or DIANA. The winners were announced Monday evening at the Association’s 2012 Business and Leadership Conference in San Antonio, Texas.

June 8, 2012

Mylan announced that its subsidiary has resolved all disputes with Teva pertaining to the sale of generic versions of a sleep disorder drug.

PITTSBURGH — Mylan announced that its subsidiary has resolved all disputes with Teva pertaining to the sale of generic versions of a sleep disorder drug.

June 8, 2012

Walmart has partnered with En-Vision America to launch a pilot program that provides those who cannot read standard print a safe and easy way to access the information on their prescriptions.

BENTONVILLE, Ark. — Walmart has partnered with En-Vision America to launch a pilot program that provides those who cannot read standard print a safe and easy way to access the information on their prescriptions.

June 7, 2012

Government authorities are working to educate independent pharmacy owners on prescription drug abuse, an independent pharmacy network said.

SCOTTSBORO, Ala. — Government authorities are working to educate independent pharmacy owners on prescription drug abuse, an independent pharmacy network said.

In an event sponsored by American Associated Pharmacies in San Diego, Drug Enforcement Administration deputy assistant administrator for the Office of Diversion Control Joseph Rannazzisi discussed topics related to prescription drug abuse. Rannazzisi explained how drug abusers divert prescription drugs through doctor shopping, forged prescriptions, theft and the Internet.