Content about Acetamides

March 18, 2014

Natco Pharma received tentative approval from the Food and Drug Administration to launch a generic version of Roche Holding AG's Tamiflu, according to a recent report. The drug is used to treat bird and swine flu.

HYDERABAD — Natco Pharma received tentative approval from the Food and Drug Administration to launch a generic version of Roche Holding AG's Tamiflu, according to a recent report. The drug is used to treat bird and swine flu.

January 28, 2014

The same H1N1 virus to cause a pandemic in 2009 is by far the predominant influenza virus for the 2013-2014 season. This is the first season that the H1N1 virus has circulated at high levels since the pandemic.

The same H1N1 virus to cause a pandemic in 2009 is by far the predominant influenza virus for the 2013-2014 season. This is the first season that the H1N1 virus has circulated at high levels since the pandemic.

However, the Northern Hemisphere quadrivalent and trivalent vaccines for the 2013-2014 season are well-matched to the H1N1 virus in circulation, according to the Centers for Disease Control and Prevention’s FluView report for the week ended Jan. 4.

January 24, 2014

Perrigo announced that it received final approval from the Food and Drug Administration for repaglinide tablets — a generic version of Prandin tablets.

DUBLIN — Perrigo Co. announced that it received final approval from the Food and Drug Administration for repaglinide tablets — a generic version of Prandin tablets — in 1-mg and 2-mg strengths. The company has started shipment of the drug. Perrigo previously launched the 0.5-mg strength in 2013.

January 23, 2014

Mylan announced that its U.S.-based subsidiary has launched repaglinide tablets, a generic version of Novo Nordisk's Prandin.

PITTSBURGH — Mylan on Thursday announced that its subsidiary has launched repaglinide tablets, a generic version of Novo Nordisk's Prandin. The drug is used to improve glycemic control in adults with Type 2 diabetes mellitus.

Repaglinide tablets in 0.5 mg, 1 mg and 2 mg had sales in the United States of approximately $212.95 million for the 12 months ending Sept. 30, 2013, according to IMS Health.

 

January 20, 2014

Higher levels of melatonin, a hormone involved in the sleep-wake cycle, may decrease the risk of developing advanced prostate cancer, according to results presented here at the AACR-Prostate Cancer Foundation Conference on Advances in Prostate Cancer Research, held Jan. 18-21.

SAN DIEGO — Higher levels of melatonin, a hormone involved in the sleep-wake cycle, may decrease the risk of developing advanced prostate cancer, according to results presented here at the AACR-Prostate Cancer Foundation Conference on Advances in Prostate Cancer Research, held Jan. 18-21.

January 13, 2014

According to this week's FluView report, overall flu activity continued to be high across the nation, with activity continuing to spread from state to state, the Centers for Disease Control and Prevention reported Friday.

ATLANTA — According to this week's FluView report, overall flu activity continued to be high across the nation, with activity continuing to spread from state to state, the Centers for Disease Control and Prevention reported Friday. Thirty-five states are now experiencing widespread activity, and 20 states are reporting high levels of influenza-like illness. 

November 27, 2013

Treatment of influenza with antiviral medicines like Tamiflu and Relenza may improve survival rates in children, according to a study published Nov. 25 in Pediatrics.

ELK GROVE VILLAGE, Ill. — Treatment of influenza with such antiviral medicines as Tamiflu and Relenza may improve survival rates in children, according to a study published on Nov. 25 in Pediatrics

Researchers from the California Department of Public Health analyzed data abstracted from medical records to characterize the outcomes of pediatric patients hospitalized with the flu between April 3, 2009 and September 30, 2012. 

November 4, 2013

Drug maker UCB is seeking approval for one of its drugs as a standalone therapy for epilepsy.

ATLANTA — Drug maker UCB is seeking approval for one of its drugs as a stand-alone therapy for epilepsy.

The company said Monday that the Food and Drug Administration had accepted its regulatory approval application for Vimpat (lacosamide) for adult epilepsy patients with partial-onset seizures. The drug is already approved as an add-on therapy for partial-onset seizures in patients aged 17 and older.

October 29, 2013

Generic drug maker Amneal Pharmaceuticals is seeking Food and Drug Administration approval for a gout drug, prompting a lawsuit from the maker of the branded version, according to published reports.

NEW YORK — Generic drug maker Amneal Pharmaceuticals is seeking Food and Drug Administration approval for a gout drug, prompting a lawsuit from the maker of the branded version, according to published reports.

Law360 reported that Takeda Pharmaceuticals USA had sued Amneal in the U.S. District Court for the District of Delaware over the drug Colcrys (colchicine), used to treat gout and familial Mediterranean fever.

October 10, 2013

A subsidiary of Johnson & Johnson has acquired rights to an experimental drug for hepatitis C from GlaxoSmithKline.

TITUSVILLE, N.J. — A subsidiary of Johnson & Johnson has acquired rights to an experimental drug for hepatitis C from GlaxoSmithKline.

Janssen Pharmaceuticals announced that it had bought, for an undisclosed among, the drug GSK2336805 from GSK. The drug, which belongs to a class known as NS5a replication complex inhibitors, is currently in mid-stage development.

July 31, 2013

The Food and Drug Administration has given Lupin Pharmaceuticals tentative approval to two of its products, the company said Wednesday.

BALTIMORE — The Food and Drug Administration has given Lupin Pharmaceuticals tentative approval to two of its products, the company said Wednesday.

Lupin announced the tentative approvals for armodafinil tablets in the 50-mg, 100-mg, 150-mg, 200-mg and 250-mg strengths and doxycycline capsules in the 40-mg strength. Tentative approval means that the drugs meet the FDA's conditions for approval, but can't be marketed yet due to patent or market exclusivity protection that has yet to expire.

July 19, 2013

Perrigo announced the tentative approval for repaglinide tablets, a generic version of Novo Nordisk's Prandin, used to treat Type 2 diabetes.

ALLEGAN, Mich. – The Food and Drug Administration has given tentative approval to a generic diabetes drug.

Perrigo Co. announced the tentative approval for repaglinide tablets, a generic version of Novo Nordisk's Prandin, used to treat Type 2 diabetes.

July 12, 2013

Actavis is looking to become the first to market a generic drug for epilepsy, the company said.

PARSIPPANY, N.J. — Actavis is looking to become the first to market a generic drug for epilepsy, the company said Friday.

Actavis announced that it had filed with the Food and Drug Administration for lacosamide tablets in the 50-mg, 100-mg, 150-mg and 200-mg strengths. The drug is a generic version of UBC's Vimpat and is used to treat partial-onset seizures in epilepsy patients aged 17 and older.

July 12, 2013

The Indian generic drug maker announced the approval of repaglinide tablets in the 1-mg and 2-mg strengths, which are used in combination with diet and exercise to improve blood-sugar control in patients with Type 2 diabetes.

MUMBAI, India — The Food and Drug Administration has approved a generic diabetes drug made by Sun Pharmaceutical Industries, Sun said Friday.

The Indian generic drug maker announced the approval of repaglinide tablets in the 1-mg and 2-mg strengths, which are used in combination with diet and exercise to improve blood-sugar control in patients with Type 2 diabetes.

April 30, 2013

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.

January 22, 2013

The Food and Drug Administration on Friday approved the distribution of 2 million additional doses of Tamiflu (oseltamivir phosphate) 75 mg that contain an older version of the package insert.

ATLANTA — The Food and Drug Administration on Friday approved the distribution of 2 million additional doses of Tamiflu (oseltamivir phosphate) 75 mg that contain an older version of the package insert.

January 18, 2013

The Food and Drug Administration is allowing Roche to tap its reserves of the flu drug Tamiflu, according to published reports.

NEW YORK — The Food and Drug Administration is allowing Roche to tap its reserves of the flu drug Tamiflu, according to published reports.

Reuters reported that the Swiss drug maker would start selling its reserve stock of the adult formulation of the drug, whose chemical name is oseltamivir.

The FDA has reported spot shortages of the pediatric formulation of the drug, but has said pharmacists can break open the capsules and dissolve it in liquid to create a substitute. Meanwhile, a shortage of the adult formulation has appeared in Canada.

January 14, 2013

As if the reported spot shortages of flu vaccine aren't bad enough, there have been reports of similar shortages of flu drugs throughout the United States and parts of Canada due to increased demand.

As if the reported spot shortages of flu vaccine aren't bad enough, there have been reports of similar shortages of flu drugs throughout the United States and parts of Canada due to increased demand.

December 21, 2012

The Food and Drug Administration has approved a common flu drug for use in children as young as 2 weeks old, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a common flu drug for use in children as young as 2 weeks old, the agency said Friday.

The FDA announced the new approval for Genentech's Tamiflu (oseltamivir). The agency said that while patients ages 1 year and older can receive the same dosage, those younger than 1 year must be dosed based on their exact weight.