Content about Eli Lilly and Company

April 10, 2014

Lupin announced that it received final approval from the Food and Drug Administration for pioglitazone tablets USP in 15-mg, 30-mg and 45-mg strengths.

MUMBAI and BALTIMORE — Lupin announced that it received final approval from the Food and Drug Administration for pioglitazone tablets USP in 15-mg, 30-mg and 45-mg strengths. The product is the generic version of Actos tablets from Takeda Pharmaceuticals.

The drug is used an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes. Actos tablets had annual sales in the United States of approximately $236 million as of December 2013, according to IMS MAT data. 

 

April 3, 2014

MannKind Corp. on Tuesday announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the Food and Drug Administration voted 13-to-1 to recommend that Afrezza (insulin human [rDNA origin]) inhalation powder be granted marketing approval by the FDA to improve glycemic control in adults with Type 1 diabetes and voted 14-to-0 to recommend that Afrezza be granted marketing approval by the FDA to improve glycemic control in adults with Type 2 diabetes.

VALENCIA, Calif. — MannKind Corp. on Tuesday announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the Food and Drug Administration voted 13-to-1 to recommend that Afrezza (insulin human [rDNA origin]) inhalation powder be granted marketing approval by the FDA to improve glycemic control in adults with Type 1 diabetes and voted 14-to-0 to recommend that Afrezza be granted marketing approval by the FDA to improve glycemic control in adults with Type 2 diabetes. 

April 1, 2014

Prasco Labs on Tuesday announced that it has signed a marketing and distribution agreement with Eli Lilly and Co. to market the authorized generic version of Evista (raloxifene hydrochloride tablets), 60 mg strength, in the United States.

CINCINNATI — Prasco Labs on Tuesday announced that it has signed a marketing and distribution agreement with Eli Lilly and Co. to market the authorized generic version of Evista (raloxifene hydrochloride tablets), 60 mg strength, in the United States.

April 1, 2014

Teva Pharmaceuticals on Tuesday announced the introduction and availability of Raloxifene hydrochloride tablets, USP.

JERUSALEM — Teva Pharmaceuticals on Tuesday announced the introduction and availability of Raloxifene hydrochloride tablets, USP. This product is AB rated and bioequivalent to Evista tablets.  

Raloxifene hydrochloride tablets, USP are indicated for the treatment and prevention of osteoporosis in postmenopausal women. 

Teva was first to file, making the product eligible for 180 days of marketing exclusivity.

March 4, 2014

Teva Pharmaceutical Industries announced that it received approval for generic Evista (raloxifene) tablets, 60-mg, in the United States.

JERUSALEM — Teva Pharmaceutical Industries on Tuesday announced that it received approval for generic Evista (raloxifene) tablets, 60-mg, in the United States. The company was the first to file, which means the product is eligible for 180 days of marketing exclusivity. Teva will begin shipping the drug within the next 30 days.

Evista 60-mg tablets, marketed by Eli Lilly and Co., had annual sales in the United States of approximately $824 million as of December 2013, according to IMS data. The drug is used to prevent and treat osteoporosis in postmenopausal women.

March 3, 2014

AstraZeneca received approval from the Food and Drug Administration for its Bydureon pen (exenatide extended-release for injectable suspension) 2-mg, which is to be used as an addition to diet and exercise to improve glycemic control in adults with Type 2 diabetes.

WILMINGTON, Del. — AstraZeneca received approval from the Food and Drug Administration for its Bydureon pen (exenatide extended-release for injectable suspension) 2-mg, which is to be used as an addition to diet and exercise to improve glycemic control in adults with Type 2 diabetes.

The Bydureon pen is a pre-filled, single-use pen injector, which eliminates the need for the patient to transfer their medication between a vial and syringe during the process of self-injection. The pen contains the same formula and dose as the original Bydureon single-dose tray.

February 28, 2014

Pharma Supply earlier this week launched NeedleBay, a safe and easy method of organizing and dispensing insulin pen needles and medication.

WEST PALM BEACH, Fla. — Pharma Supply earlier this week launched NeedleBay, a safe and easy method of organizing and dispensing insulin pen needles and medication.

NeedleBay provides a highly visible, unique and simple “proof of use” reminder, which eliminates the risk of missed, or excess injections and associated medications. NeedleBay has been specially designed in consultation with healthcare professionals and those with diabetes, to enable the user to deploy disposable pen needles safely and to avoid the risk of needle pick injuries.

January 21, 2014

Novo Nordisk has launched a new insulin pen designed for children with diabetes.

NEW YORK — Novo Nordisk has launched a new insulin pen designed for children with diabetes.

The new NovoPen Echo is the first and only prefilled pen device in the United States that allows for half-unit dosing in combination with a memory function, the company said.

December 11, 2013

The Food and Drug Administration has approved the first generic versions of a drug used to treat depression and other conditions, the agency said.

SILVER SPRING, Md. – The Food and Drug Administration has approved the first generic versions of a drug used to treat depression and other conditions, the agency said Wednesday.

The FDA announced the approval of generic duloxetine delayed-release capsules manufactured by Aurobindo Pharma, Dr. Reddy's Labs, Lupin, Sun Pharmaceutical Industries, Teva Pharmaceutical Industries and Torrent Pharmaceuticals.

November 18, 2013

Drug maker Actavis hopes to become the first to market with a generic version of a topical testosterone replacement drug marketed by Eli Lilly, Actavis said.

DUBLIN — Drug maker Actavis hopes to become the first to market with a generic version of a topical testosterone replacement drug marketed by Eli Lilly, Actavis said.

The generic drug maker it filed with the Food and Drug Administration for approval of testosterone topical solution in the 30-mg-per-1.5 mL strength, a generic version of Lilly's Axiron. The drug is used as a replacement therapy for deficient or absent testosterone.

November 11, 2013

Shire will pay $4.2 billion to buy a drug maker specializing in treatments for rare diseases.

DUBLIN — Shire will pay $4.2 billion to buy a drug maker specializing in treatments for rare diseases.

Shire, headquartered in Ireland, said the $50-per-share acquisition of ViroPharma would strengthen its rare disease portfolio. Exton, Pa.-based ViroPharma's products include the hereditary angioedema drug Cinryze (C1 esterase inhibitor [human]) and Vancocin (vancomycin hydrochloride), used to treat Clostridium difficile-associated diarrhea.

November 5, 2013

The Food and Drug Administration has approved a generic injectable antibiotic drug made by Emcure Pharmaceuticals, according to the agency.

SILVER SPRING, Md. – The Food and Drug Administration has approved a generic injectable antibiotic drug made by Emcure Pharmaceuticals, according to the agency.

The FDA approved Emcure's vancomycin hydrochloride injection in the 5-g-per-vial strength.

The drug is a generic version of Vancocin, made by ViroPharma.

 

November 1, 2013

The Food and Drug Administration has approved two new insulin pens made by Novo Nordisk, the Danish drug maker said Friday.

PLAINSBORO, N.J. — The Food and Drug Administration has approved two new insulin pens made by Novo Nordisk, the Danish drug maker said Friday.

Novo Nordisk announced the FDA approval of Novolog FlexTouch (insulin aspart [rDNA origin]) and Levemir FlexTouch (insulin detemir [rDNA origin]).

October 21, 2013

The president of Indiana's Manchester University will retire next summer and has named the university's pharmacy dean as her successor.

FORT WAYNE, Ind. — The president of Indiana's Manchester University will retire next summer and has named the university's pharmacy dean as her successor.

The university, based in Fort Wayne, Ind., said Jo Young Switzer would retire on June 30, 2014 and had named EVP and College of Pharmacy dean Dave McFadden as president, effective the day after. Switzer is Manchester University's first female president.

August 21, 2013

The Food and Drug Administration has given the green light to an insulin pen made by Novo Nordisk for half-unit dosing, the drug maker said Wednesday.

PLAINSBORO, N.J. — The Food and Drug Administration has given the green light to an insulin pen made by Novo Nordisk for half-unit dosing, the drug maker said Wednesday.

July 16, 2013

Men who took an erectile dysfunction drug made by Eli Lilly experienced normal erectile function when taking it once a day as opposed to taking erectile dysfunction treatment on an as-needed basis, according to a new study.

INDIANAPOLIS — Men who took an erectile dysfunction drug made by Eli Lilly experienced normal erectile function when taking it once a day as opposed to taking erectile dysfunction treatment on an as-needed basis, according to a new study.

The study, published in the Journal of Sexual Medicine, found a greater percentage of men who had an incomplete response to as-needed treatment with phosphodiesterase type 5, or PDE5 inhibitors, a drug class that includes Lilly's Cialis (tadalafil), compared with those who took Cialis once a day.

June 21, 2013

Becton, Dickinson and Co. has launched a needle that it said would make insulin injections easier and faster for people with diabetes.

FRANKLIN LAKES, N.J. — Becton, Dickinson and Co. has launched a needle that it said would make insulin injections easier and faster for people with diabetes.

BD subsidiary BD Medical announced Friday the BD Ultra-Fine Nano 4-millimeter pen needle. The needle includes technology called EasyFlow, designed to aid faster and more comfortable injections, and product demonstrations will take place at the American Diabetes Association's 73rd annual Scientific Sessions in Chicago, lasting through next Tuesday.

June 19, 2013

Three new drugs for Type 2 diabetes made by Takeda Pharmaceutical have become available in pharmacies, the company said.

DEERFIELD, Ill. — Three new drugs for Type 2 diabetes made by Takeda Pharmaceutical Co. have become available in pharmacies, the company said.

The drug maker announced the availability of Nesina (alogliptin), Kazano (alogliptin; metformin hydrochloride) and Oseni (alogliptin; pioglitazone).

June 10, 2013

A 26-member joint panel comprising the Food and Drug Administration's Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management advisory committees voted to support modifying or removing the risk evaluation and mitigation strategy protocol for GlaxoSmithKline's Type 2 diabetes drug Avandia (rosiglitazone).

Historically, the FDA has followed advisory committee votes when making a decision on the marketing of a drug even though it is not bound by them, but assuming the agency follows the panel's advice, it could mean a lot for the controversial drug and the way it's dispensed. But even if Avandia winds up on retail pharmacy shelves again, it faces a very different landscape from its heyday.

A 26-member joint panel comprising the Food and Drug Administration's Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management advisory committees voted to support modifying or removing the risk evaluation and mitigation strategy protocol for GlaxoSmithKline's Type 2 diabetes drug Avandia (rosiglitazone).

June 7, 2013

A joint Food and Drug Administration expert panel voted to recommend keeping a controversial GlaxoSmithKline diabetes drug available for certain patients, GSK said.

PHILADELPHIA — A joint Food and Drug Administration expert panel voted to recommend keeping a controversial GlaxoSmithKline diabetes drug available for certain patients, GSK said.

April 12, 2013

Celgene Corp. chairman and CEO Robert Hugin has been elected as chairman of a pharmaceutical industry trade group.

SAN DIEGO — Celgene Corp. chairman and CEO Robert Hugin has been elected as chairman of a pharmaceutical industry trade group.

The Pharmaceutical Research and Manufacturers of America announced the election of Hugin, as well as Pfizer president and CEO Ian Read as chairman-elect of the PhRMA board of directors and Merck chairman, president and CEO as board treasurer.

Hugin succeeds Eli Lilly president, chairman and CEO John Lechleiter as chairman, PhRMA said.

 

April 12, 2013

An inspection of more than two-dozen compounding pharmacies by Food and Drug Administration officials has found widespread problems with sanitation and sterilization practices, FDA commissioner Margaret Hamburg wrote in a blog post on the agency's website Thursday.

SILVER SPRING, Md. — An inspection of more than two-dozen compounding pharmacies by Food and Drug Administration officials has found widespread problems with sanitation and sterilization practices, FDA commissioner Margaret Hamburg wrote in a blog post on the agency's website Thursday.

April 5, 2013

Novo Nordisk has launched a diabetes awareness sweepstakes in which the winners get a free trip to the 2013 IndyCar finale, the Danish drug maker said.

BIRMINGHAM, Ala. — Novo Nordisk has launched a diabetes awareness sweepstakes in which the winners get a free trip to the 2013 IndyCar finale, the Danish drug maker said Friday.

The company announced that it had hired IZOD IndyCar Series Charlie Kimball as spokesman for its Race with Insulin contest. Kimball, the first licensed driver with diabetes to race at the highest level of the series, was diagnosed with the disease during a routine doctor visit in 2007 while racing in Europe and is a user of Novo Nordisk's NovoLog (insulin aspart [rDNA origin]).

March 25, 2013

Boehringer Ingelheim and Eli Lilly are seeking regulatory approval for an experimental drug to treat Type 2 diabetes, the companies said.

RIDGEFIELD, Conn. — Boehringer Ingelheim and Eli Lilly are seeking regulatory approval for an experimental drug to treat Type 2 diabetes, the companies said Monday.

BI and Lilly announced the submission of a regulatory application to the Food and Drug Administration for empagliflozin. The drug belongs to a new drug class known as SGLT2 inhibitors, which work by removing excess glucose through the urine by blocking its reabsorption in the kidneys. The companies are testing the drug in a late-stage clinical trial for which they plan to enroll 14,500 patients.

March 22, 2013

Disease relapse rates and worsening of disability were low among patients taking a drug made by Genzyme for multiple sclerosis, the company said.

CAMBRIDGE, Mass. — Disease relapse rates and worsening of disability were low among patients taking a drug made by Genzyme for multiple sclerosis, the company said.

Genzyme, a division of French drug maker Sanofi, announced results of an extension study of the drug Lemtrada (alemtuzumab). The study was a follow-up to two other late-stage clinical studies of the drug, finding that relapse rates and sustained accumulation of disability remained low among patients who had previously received the drug.