Content about Metformin

April 19, 2013
FDA grants tentative approval to two Sun generics

The Food and Drug Administration has given tentative approval to two generic diabetes drugs made by Sun Pharmaceutical Industries, the Indian drug maker said.

MUMBAI, India — The Food and Drug Administration has given tentative approval to two generic diabetes drugs made by Sun Pharmaceutical Industries, the Indian drug maker said.

Sun announced the tentative approvals for sitagliptin tablets in the 25 mg, 50 mg and 100 mg strengths and metformin hydrochloride extended-release tablets in the 500 mg and 1,000 mg strengths. The drugs are respectively generic versions of Merck's Januvia and Santarus' Glumetza.

March 14, 2013
Mylan can launch generic diabetes drug in August

Mylan has settled a patent-infringement lawsuit filed by Shionogi over its generic version of a drug for diabetes, Mylan said.

PITTSBURGH — Mylan has settled a patent-infringement lawsuit filed by Shionogi over its generic version of a drug for diabetes, Mylan said.

The generic drug maker said that under the agreement, it can launch a generic version of Shionogi's Fortamet (metformin hydrochloride) extended-release tablets in the 500-mg and 1,000-mg strengths on Aug. 1.

Metformin hydrochloride extended-release tablets in those two strengths had sales of about $125 million during the 12-month period that ended in September, according to IMS Health.

 

February 19, 2013
FDA approves Aurobindo diabetes drug

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

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

Aurobindo announced the approval of pioglitazone tablets in the 15 mg, 30 mg and 45 mg strengths, in addition to the earlier tentative approval it received for pioglitazone and metformin hydrochloride tablets in the 15 mg/500 mg and 15 mg/850 mg strengths.

February 13, 2013
Bi-Lo expands prescription program through loyalty card

Bi-Lo on Wednesday launched in all of its pharmacies a prescription program that significantly enhances the offerings of its existing program.

GREENVILLE, S.C. — Bi-Lo on Wednesday launched in all of its pharmacies a prescription program that significantly enhances the offerings of its existing program. The expanded program runs through the Bi-Lo BonusCard and offers deep discounts on more than 450 generic medications and varied discounts on name-brand and other generic medication.

January 28, 2013
FDA approves three new drugs for Type 2 diabetes

The Food and Drug Administration has approved three new drugs for Type 2 diabetes made by Takeda, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved three new drugs for Type 2 diabetes made by Takeda, the agency said Friday.

The FDA announced the approval of Nesina (alogliptin), Kazano (alogliptin and metformin) and Oseni (alogliptin and pioglitazone) tablets.

Alogliptin is a new active ingredient, while metformin and pioglitazone are drugs already on the market.

December 12, 2012
J&J subsidiary seeks approval for Type 2 diabetes drug

A subsidiary of Johnson & Johnson is seeking regulatory approval for a new Type 2 diabetes drug.

RARITAN, N.J. — A subsidiary of Johnson & Johnson is seeking regulatory approval for a new Type 2 diabetes drug.

J&J division Janssen Research & Development announced Wednesday that it had filed with the Food and Drug Administration for a drug combining the experimental drug canagliflozin and immediate-release metformin, a common generic drug for diabetes.

The company also submitted a regulatory approval application to the FDA for canagliflozin in May 2012.

December 3, 2012
Diabetes drug appears to improve survival in women with ovarian cancer

Women with ovarian cancer and diabetes who took the generic diabetes drug metformin showed better survival rates than those who did not take the drug, according to a new study led by the Mayo Clinic.

NEW YORK — Women with ovarian cancer and diabetes who took the generic diabetes drug metformin showed better survival rates than those who did not take the drug, according to a new study led by the Mayo Clinic.

The study, published in the journal Cancer, enrolled 61 patients who took metformin and 178 who didn't. Of those who took the drug, 67% were surviving after five years, compared with 47% of those who didn't take it. Further analysis indicated that patients taking metformin were almost four times likelier to survive than those not taking it.

September 14, 2012
Lilly, BI launch diabetes-education program

Drug makers Boehringer Ingelheim and Eli Lilly have created a new online educational program for people with Type 2 diabetes.

INDIANAPOLIS — Drug makers Boehringer Ingelheim and Eli Lilly have created a new online educational program for people with Type 2 diabetes.

The companies, which have had a deal to develop drugs for diabetes since January 2011 and co-market the drugs Tradjenta (linagliptin) and Jentadueto (linagliptin and metformin), announced Thursday the creation of My Well Planner, a lifestyle-improvement program for adults with the disease.

August 27, 2012
FDA approves generic version of Actos

The Food and Drug Administration has approved the first generic version of a diabetes drug made by Takeda, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved the first generic version of a diabetes drug made by Takeda, the agency said Friday.

July 23, 2012
Study: Long-term use of linagliptin among Type 2 diabetics is effective

Extended use of the oral DPP-4 inhibitor linagliptin to lower blood-glucose levels by Type 2 diabetes patients is effective, according to a new study.

NEW YORK — Extended use of the oral DPP-4 inhibitor linagliptin to lower blood-glucose levels by Type 2 diabetes patients is effective, according to a new study.

A team of eight researchers — four of which work for drug maker Boehringer Ingelheim — examined 2,121 Type 2 diabetes patients that had taken part in four previous 24-week randomized, double-blind, placebo-controlled trials in order to monitor them for a further 78 weeks. The participants who took part in the extended trial came from 231 sites in 32 countries.

May 16, 2012
Amneal adds blackberry flavoring to generic diabetes drug

Amneal Pharmaceuticals is adding blackberry flavoring to a generic diabetes drug following feedback from customers, the company said Wednesday.

BRIDGEWATER, N.J. — Amneal Pharmaceuticals is adding blackberry flavoring to a generic diabetes drug following feedback from customers, the company said Wednesday.

Amneal announced the changes to its metformin hydrochloride immediate-release tablets in the 500-mg, 850-mg and 1,000-mg strengths, designed to cover up the smell of metformin.

April 23, 2012
Watson launches authorized generic diabetes drug

Watson Pharmaceuticals announced the launch of an authorized generic version of a drug used to lower blood glucose in patients with Type 2 diabetes.

PARSIPPANY, N.J. — Watson Pharmaceuticals announced the launch of an authorized generic version of a drug used to lower blood glucose in patients with Type 2 diabetes.

April 19, 2012
Watson seeks approval for generic Type 2 diabetes drug

Generic drug maker Watson is challenging the patent protection on a drug used to treat Type 2 diabetes.

PARSIPPANY, N.J. — Generic drug maker Watson is challenging the patent protection on a drug used to treat Type 2 diabetes.

Watson said Thursday that it had filed with the Food and Drug Administration for approval of a generic version of Depomed's Glumetza (metformin hydrochloride extended-release tablets) in the 1,000-mg strength.

April 9, 2012
FDA approves labeling change for Novo Nordisk diabetes drug

The Food and Drug Administration has approved a change to the label of a Novo Nordisk drug stating that it offers superior blood-sugar control to a competing drug made by Merck, based on results of two clinical studies, Novo Nordisk said Monday.

PRINCETON, N.J. — The Food and Drug Administration has approved a change to the label of a Novo Nordisk drug stating that it offers superior blood-sugar control to a competing drug made by Merck, based on results of two clinical studies, Novo Nordisk said Monday.

April 2, 2012
Metformin may help slow progression, reduce risk of certain cancers

A medication commonly prescribed for patients with Type 2 diabetes also may play a critical role in patients at risk of developing certain cancers.

NEW YORK — A medication commonly prescribed for patients with Type 2 diabetes also may play a critical role in patients at risk of developing certain cancers.

In three separate studies published in Cancer Prevention Research, a journal of the American Association for Cancer Research, findings showed how metformin may protect against oral cancer and liver cancer, as well as slow the growth rate of prostate cancer among men prior to prostatectomy.

March 29, 2012
Study suggests metformin may help prevent heart disease

A commonly prescribed diabetes drug also may have the capability of protecting the heart, according to a Swedish study.

NEW YORK — A commonly prescribed diabetes drug also may have the capability of protecting the heart, according to a Swedish study.

March 26, 2012
Report: Metformin cost-effective strategy in battling diabetes

Lifestyle intervention and treatment with metformin provide safe, long-term, cost-effective means of preventing Type 2 diabetes and should be incorporated into prevention strategies for reducing the dramatic rise in incidence of Type 2 diabetes in the United States, according to two new analyses and an editorial published in the April issue of Diabetes Care.

ALEXANDRIA, Va. — Lifestyle intervention and treatment with metformin provide safe, long-term, cost-effective means of preventing Type 2 diabetes and should be incorporated into prevention strategies for reducing the dramatic rise in incidence of Type 2 diabetes in the United States, according to two new analyses and an editorial published in the April issue of Diabetes Care.

March 26, 2012
ReportersNotebook — Chain Pharmacy, 4/2/12

A drug under development by Forest Labs and Pierre Fabre has been shown to reduce symptoms of major depressive disorder, the companies said.

SUPPLIER NEWS — A drug under development by Forest Labs and Pierre Fabre has been shown to reduce symptoms of major depressive disorder, the companies said. New York-based Forest and Paris-based Pierre Fabre announced results of a phase-3 trial of levomilnacipran, saying the drug showed reductions in symptoms as early as one week after treatment was started. The companies expect results of another phase-3 trial of the drug this spring.


 

March 7, 2012
Diabetes drug from Lilly, BI hits shelves

A new drug for Type 2 diabetes made by Eli Lilly and Boehringer Ingelheim is available in pharmacies, the companies said Wednesday.

INDIANAPOLIS — A new drug for Type 2 diabetes made by Eli Lilly and Boehringer Ingelheim is available in pharmacies, the companies said Wednesday.

The two companies announced the availability of Jentadueto (linagliptin and metformin hydrochloride). The Food and Drug Administration approved the drug on Jan. 30.

February 2, 2012
FDA approves Merck diabetes drug

The Food and Drug Administration has approved a drug made by Merck for Type 2 diabetes, the drug maker said Thursday.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has approved a drug made by Merck for Type 2 diabetes, the drug maker said Thursday.

Merck announced the approval of Janumet XR (sitagliptin and metformin hydrochloride) extended-release tablets as a once-daily treatment for the disease.

February 1, 2012
Study: Link between diabetes drugs, pancreatic cancer risk unclear

A new study published in the American Journal of Gastroenterology examined the possible link between pancreatic cancer and drugs designed to treat diabetes, and found the association to be unclear.

NEW YORK — A new study published in the American Journal of Gastroenterology examined the possible link between pancreatic cancer and drugs designed to treat diabetes, and found the association to be unclear.

Researchers conducted a case-control study based on the British-based General Practice Research Database, which included drug prescriptions, diagnostics, hospitalizations and fatality information. The researchers also took into consideration such factors as body mass index, smoking, alcohol consumption and diabetes duration.

January 9, 2012
Mylan seeks approval for generic diabetes drug

Generic drug maker Mylan is challenging the patent on a drug used to treat diabetes, the company said Monday.

PITTSBURGH — Generic drug maker Mylan is challenging the patent on a drug used to treat diabetes, the company said Monday.

Mylan said that it was sued by Takeda Pharmaceutical, Watson Pharmaceuticals and Andrx Labs in the U.S. District Court for the Southern District of New York in response to Mylan's filing a regulatory approval application with the Food and Drug Administration for a generic version of Actoplus Met XR (pioglitazone hydrochloride and metformin hydrochloride) extended-release tablets in the 15-mg/1,000-mg and 30-mg/1,000-mg strengths.

December 8, 2011
Eli Lilly, Boehringer Ingelheim announce linagliptin trial results

A drug currently under clinical development for Type 2 diabetes produced "meaningful" reductions in blood sugar, according to results of a late-stage clinical study.

INDIANAPOLIS — A drug currently under clinical development for Type 2 diabetes produced "meaningful" reductions in blood sugar, according to results of a late-stage clinical study.

Eli Lilly & Co. and Boehringer Ingelheim announced results of a 24-week, open-label arm of a phase-3 study of the investigational drug linagliptin combined with the generic drug metformin, presenting results at the International Diabetes Federation World Diabetes Conference in Dubai.

November 28, 2011
Study: Metformin may reduce risk of cancer

A drug commonly used to treat Type 2 diabetes may reduce the risk of diabetes-associated cancers, including breast cancer, according to a new study.

EAST LANSING, Mich. — A drug commonly used to treat Type 2 diabetes may reduce the risk of diabetes-associated cancers, including breast cancer, according to a new study.

November 28, 2011
Takeda files for approval of alogliptin-metformin combination tablet

A U.S. subsidiary of Takeda Pharmaceutical has filed for regulatory approval of a drug designed to treat Type 2 diabetes, the company said.

OSAKA, Japan — A U.S. subsidiary of Takeda Pharmaceutical has filed for regulatory approval of a drug designed to treat Type 2 diabetes, the company said.

The Takeda Global Research and Development Center filed with the Food and Drug Administration for approval of an alogliptin-metformin combination tablet. The company expects the FDA to review the application within the next 10 months.