Content about Generics

October 22, 2013

Keeping counterfeit and diverted drugs out of the U.S. drug supply chain will require closing vulnerable regulatory gaps that risk letting them in, according to a new report by the National Association of Boards of Pharmacy.

NEW YORK — Keeping counterfeit and diverted drugs out of the U.S. drug supply chain will require closing vulnerable regulatory gaps that risk letting them in, according to a new report by the National Association of Boards of Pharmacy.

October 22, 2013

The state Senate of Pennsylvania will vote on a bill to curb misuse of prescription drugs, according to published reports.

NEW YORK — The state Senate of Pennsylvania will vote on a bill to curb misuse of prescription drugs, according to published reports.

The Beaver County, Pa., Times reported that Pennsylvania House Bill 1694 cleared the lower house of the state legislature in a 191-7 vote. The bill is designed to stop doctor-shopping and pill mills by creating an electronic prescription drug database to track drugs dispensed by doctors and veterinarians. Doctors and pharmacists can then use it to verify patients' medication histories.

October 22, 2013

Teva Pharmaceutical Industries is investing more than $100 million in its Croatian division for a plant that will make pills mostly for the international market.

ZAGREB, Croatia — Teva Pharmaceutical Industries is investing more than $100 million in its Croatian division for a plant that will make pills mostly for the international market.

Teva subsidiary Pliva said the new plant, in the capital of Zagreb, would considerably increase its production capacities for tablets and capsules. The company said the new plant would increase the annual manufacturing capacity by more than 25%.

October 22, 2013

WebMD Health on Monday announced the availability of the WebMD Cold and Flu Symptoms Across the Nation map and companion health center to help consumers stay ahead of cold and flu symptoms this season.

NEW YORK — WebMD Health on Monday announced the availability of the WebMD Cold and Flu Symptoms Across the Nation map and companion health center to help consumers stay ahead of cold and flu symptoms this season.  

October 18, 2013

Giant Food Stores and Martin's Food Markets — collectively known as Giant-Carlisle — will sponsor drug take-back events at more than three dozen stores next weekend.

CARLISLE, Pa. — Giant Food Stores and Martin's Food Markets — collectively known as Giant-Carlisle — will sponsor drug take-back events at more than three dozen stores next weekend.

The Ahold USA-owned supermarket banner said customers could bring expired and unwanted drugs to 42 stores on Oct. 26; 40 of the stores are in Pennsylvania, and two are in Virginia.

October 17, 2013

As knock-off versions of biotech drugs get closer to reality in the United States, one issue that has emerged has centered on what to call them.

NEW YORK — As knock-off versions of biotech drugs get closer to reality in the United States, one issue that has emerged has centered on what to call them.

October 17, 2013

Generic drug maker Mylan has appointed Jacek Glinka as president of its European division, the company said Thursday.

PITTSBURGH — Generic drug maker Mylan has appointed Jacek Glinka as president of its European division, the company said Thursday.

Glinka's appointment becomes effective Dec. 2. Before joining Mylan, he was CEO of Polpharma Group from 2003 to 2006 and again from 2009 until this year, helping the company expand from a small, local company to a leading drug company in central and eastern Europe, the Caucasus and Central Asia. The company became a leader in the Polish market and doubled its sales to more than $1 billion between 2011 and 2013.

October 17, 2013

Prasco Labs will distribute an authorized generic for reducing serum phosphate in patients with end-stage renal disease under a contract with Shire, Prasco said Thursday.

CINCINNATI — Prasco Labs will distribute an authorized generic for reducing serum phosphate in patients with end-stage renal disease under a contract with Shire, Prasco said Thursday.

The company, which focuses on authorized generic drugs, announced the deal for lanthanum carbonate chewable tablets in the 500-mg, 750-mg and 1,000-mg strengths. The drug is a version of Shire's Fosrenol. Authorized generics are branded drugs marketed under their generic names at a discounted price, usually through a third-party company under contract with the branded drug's manufacturer.

October 16, 2013

Mission Pharmacal on Wednesday announced that a federal district court in Texas has upheld its patent that covers the company's prescription-only prenatal vitamin brands.

SAN ANTONIO — Mission Pharmacal on Wednesday announced that a federal district court in Texas has upheld its patent that covers the company's prescription-only prenatal vitamin brands. "Mission Pharmacal has successfully asserted the dual-iron ('247) patent used in its popular CitraNatal family of prenatal vitamins, preserving Mission Pharmacal's high quality formulation pregnant women have counted on for years," stated Mission Pharmacal general counsel Lee Cusenbary.

October 16, 2013

Medicare beneficiaries' use of medications — both effective and risky — varies widely across different regions of the United States, according to a new report.

LEBANON, N.H. — Medicare beneficiaries' use of medications — both effective and risky — varies widely across different regions of the United States, according to a new report.

October 16, 2013

The 2012-2013 flu season was one of the most severe in the United States in more than a decade and, according to a new study, had two to three times the impact than a more typical flu season on the workplace, school, family and other segments of people’s everyday lives.

DEERFIELD, Ill. — The 2012-2013 flu season was one of the most severe in the United States in more than a decade and, according to a new study, had two to three times the impact than a more typical flu season on the workplace, school, family and other segments of people’s everyday lives. A new report from Walgreens released Wednesday suggests U.S. adults missed 230 million work days last season, while children lost more than 90 million school days due to flu-related illness.  

October 15, 2013

Actavis is hoping to become the first to market a generic version of a drug used to treat patients who have become dependent on opioid drugs, triggering a lawsuit from the branded drug's manufacturer.

DUBLIN — Actavis is hoping to become the first to market a generic version of a drug used to treat patients who have become dependent on opioid drugs, triggering a lawsuit from the branded drug's manufacturer.

The generic drug maker said it had filed a regulatory approval application with the Food and Drug Administration for buprenorphine hydrochloride and naloxone hydrochloride sublingual film in the 2-mg/0.5-mg and 8-mg/2-mg strengths. The drug is a generic version of Reckitt Benckiser's Suboxone.

October 15, 2013

The Food and Drug Administration has approved a new generic drug from Teva Pharmaceutical Industries for treating eye infections, the company said.

JERUSALEM — The Food and Drug Administration has approved a new generic drug from Teva Pharmaceutical Industries for treating eye infections, the company said.

The Israeli drug maker announced the approval of the antibiotic drug tobramycin inhalation solution, a generic version of Novartis' Tobi.

Tobi has sales of about $350 million during the 12-month period that ended in June, according to IMS Health.

 

October 15, 2013

Independent pharmacies are focusing more on helping patients adhere to their medication therapies and save money by using generics, according to a new digest for members of a trade group that represents independents.

ORLANDO, Fla. — Independent pharmacies are focusing more on helping patients adhere to their medication therapies and save money by using generics, according to a new digest for members of a trade group that represents independents.

October 15, 2013

Calling it a "looming threat," the National Council on Patient Information and Education released a 10-step plan to draw attention to the problem of poor medication adherence among elderly people with multiple chronic conditions.

WASHINGTON — Calling it a "looming threat," the National Council on Patient Information and Education released a 10-step plan to draw attention to the problem of poor medication adherence among elderly people with multiple chronic conditions.

October 15, 2013

Nearly half of patients with schizophrenia don't comply with doctors' prescription instructions, according to a new physician survey.

NEW YORK — Nearly half of patients with schizophrenia don't comply with doctors' prescription instructions, according to a new physician survey.

October 14, 2013

The governor of California has vetoed a bill that critics said would have limited patients' access to knock-off versions of biotech drugs.

NEW YORK — The governor of California has vetoed a bill that critics said would have limited patients' access to knock-off versions of biotech drugs.

October 14, 2013

More than three-quarters of Medicare beneficiaries don't compare drug prices when shopping for their health plans, according to a new study.

MOUNTAIN VIEW, Calif. — More than three-quarters of Medicare beneficiaries don't compare drug prices when shopping for their health plans, according to a new study.

The study, conducted by eHealth, found that 78% of respondents don't compare prices, but that the average beneficiary could have saved more than $600 this year on out-of-pocket prescription drug costs if he had. The study was based on an analysis of more than 450,000 unique visitor sessions during Medicare's 2013 Annual Enrollment Period.

October 10, 2013

When it comes to laws and regulations, what happens in Europe stays in Europe generally, and doesn’t have much bearing on the United States. But a recent win in Europe for U.S. drug maker Hospira could have some implications for the United States as well.

When it comes to laws and regulations, what happens in Europe stays in Europe generally, and doesn’t have much bearing on the United States. But a recent win in Europe for U.S. drug maker Hospira could have some implications for the United States as well.

Last month, the company — which specializes in making generic injectable drugs — announced that European Union regulators had approved the continent’s first biosimilar monoclonal antibody.

October 10, 2013

One of the Food and Drug Administration's top regulators is not retiring, contrary to rumors reported in news media Thursday.

SILVER SPRING, Md. – One of the Food and Drug Administration's top regulators is not retiring, contrary to rumors reported in news media Thursday.

In a memo sent out to staff, Center for Drug Evaluation and Research director Janet Woodcock wrote that she would not retire, but was becoming "more deeply involved" in such activities as proposed reorganizations of the Office of Pharmaceutical Quality and the Office of Generic Drugs.

October 10, 2013

For the Food and Drug Administration’s Office of Generic Drugs, one of the biggest stumbling blocks has been its significant backlog of generic drug approval applications. But it’s steadily making progress in addressing the problem.

For the Food and Drug Administration’s Office of Generic Drugs, one of the biggest stumbling blocks has been its significant backlog of generic drug approval applications. But it’s steadily making progress in addressing the problem.

When Congress approved a reauthorization of the Prescription Drug User Fee Act that included the Generic Drug User Fee Amendments last year, that backlog included about 2,500 applications. But thanks to GDUFA, the agency has managed to clear muchof it.

October 10, 2013

A coalition of organizations that includes major retail pharmacy and drug manufacturing groups is warning consumers against purchasing drug from foreign, online outlets.

NEW YORK — A coalition of organizations that includes major retail pharmacy and drug manufacturing groups is warning consumers against purchasing drugs from foreign, online outlets.

October 10, 2013

The drug market in Brazil is expected to grow to nearly $60 billion by the next decade, but problems remain with coverage of the population, according to a new report.

LONDON — The drug market in Brazil is expected to grow to nearly $60 billion by the next decade, but problems remain with coverage of the population, according to a new report.

The report, by research and consulting firm GlobalData, found that the Brazilian market would experience compounded annual growth of 12.7%, expanding from $12.4 billion in 2007 to $58.8 billion in 2020.

October 9, 2013

A new law in Maine will allow consumers to purchase drugs by mail order from some pharmacies overseas, according to published reports.

NEW YORK — A new law in Maine will allow consumers to purchase drugs by mail order from some pharmacies overseas, according to published reports.

The Wall Street Journal reported Wednesday that the law, a first, had sparked lawsuits from drug companies, who say the law will threaten patient safety by opening the U.S. supply chain to counterfeit and adulterated medications. Supporters of the law, including Republican Gov. Paul LePage, say drug makers are more concerned about losing money from the law.

October 8, 2013

A Republican congressman from Alabama has proposed a stopgap bill that would fund the Food and Drug Administration through the middle of December or until the government shutdown ends, though it is unlikely to pass in the Senate.

NEW YORK — A Republican congressman from Alabama has proposed a stopgap bill that would fund the Food and Drug Administration through the middle of December or until the government shutdown ends, though it is unlikely to pass in the Senate.