Content about Eli Lilly and Company

February 19, 2013

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 19, 2013

Mylan and Biocon have a deal to develop and sell generic insulin-analog products for diabetes, Mylan said.

PITTSBURGH — Mylan and Biocon have a deal to develop and sell generic insulin-analog products for diabetes, Mylan said.

Under the deal, Mylan will have the rights to develop and market Biocon's Glargine, Lispro and Aspart, respectively generic versions of Sanofi's Lantus, Eli Lilly's Humalog and Novo Nordisk's NovoLog.

February 11, 2013

The Food and Drug Administration declined to approve two insulin products made by Danish drug maker Novo Nordisk, the company said Sunday.

BAGSVÆRD, Denmark — The Food and Drug Administration declined to approve two insulin products made by Danish drug maker Novo Nordisk, the company said Sunday.

Novo Nordisk said it received complete response letters from the FDA for Tresiba (insulin degludec) and Ryzodeg (insulin degludec and insulin aspart). The FDA issues a complete response letter when it has finished reviewing an application for a drug, but determines that the application can't be approved in its current form.

February 8, 2013

The Food and Drug Administration has approved a generic diabetes drug made by Macleods Pharma, according to agency records.

SILVER SPRING, Md. - The Food and Drug Administration has approved a generic diabetes drug made by Macleods Pharma, according to agency records.

The FDA approved Macleods' pioglitazone hydrochloride tablets in the 15 mg, 30 mg and 45 mg strengths.

The drug is a generic version of Takeda's Actos, branded and generic versions of which had sales of about $2.7 billion during the 12-month period that ended in August 2012, according to IMS Health.

January 29, 2013

Eli Lilly and Company reported that its fourth quarter revenue for the period ended Dec. 31 declined 1% to $6 billion because of its Zyprexa patent expiration. Full-year 2012 revenue declined 7% to $22.6 billion.

INDIANAPOLIS — Eli Lilly and Company on Tuesday reported that its fourth quarter revenue for the period ended Dec. 31 declined 1% to $6 billion because of its Zyprexa patent expiration. Full-year 2012 revenue declined 7% to $22.6 billion.

January 28, 2013

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 6, 2012

The Food and Drug Administration has given special designation to a treatment made by Biodel for patients with congenital hyperinsulinism, a rare disorder that affects children.

DANBURY, Conn. — The Food and Drug Administration has given special designation to a treatment made by Biodel for patients with congenital hyperinsulinism, a rare disorder that affects children.

Biodel announced that it had received orphan drug designation for glucagon to prevent hypoglycemia, or abnormally low blood sugar, in patients with CHI.

November 9, 2012

A Food and Drug Administration panel has voted to support two experimental insulin treatments made by Novo Nordisk, the Danish drug maker said Thursday.

BAGSVÆRD, Denmark — A Food and Drug Administration panel has voted to support two experimental insulin treatments made by Novo Nordisk, the Danish drug maker said Thursday.

Novo Nordisk said the FDA's Endocrinologic and Metabolic Drugs Advisory Committee had voted 8-to-4 in favor of approval for insulin degludec and a combination treatment containing insulin degludec and insulin aspart.

November 2, 2012

Eli Lilly is spending $140 million to expand its insulin manufacturing plant in Indianapolis, the drug maker said.

INDIANAPOLIS – Eli Lilly is spending $140 million to expand its insulin manufacturing plant in Indianapolis, the drug maker said.

Lilly said it would expand the plant by 80,000 sq. ft., saying it represented one of the most significant investments in its U.S. manufacturing operations in the past decade. Construction is expected to start immediately, with completion planned for March 2014.

October 29, 2012

The Food and Drug Administration has approved a Type 2 diabetes drug made by Watson Pharmaceuticals, the company said, following a federal court's order for the agency to approve the drug.

PARSIPPANY, N.J. – The Food and Drug Administration has approved a Type 2 diabetes drug made by Watson Pharmaceuticals, the company said, following a federal court's order for the agency to approve the drug.

Watson announced the launch of pioglitazone hydrochloride tablets in the 15-mg, 30-mg and 45-mg strengths. The drug is a generic version of Takeda's Actos, branded and generic versions of which had sales of about $2.7 billion during the 12-month period ended in August, according to IMS Health.

October 24, 2012

Mylan is challenging a federal court decision ordering the Food and Drug Administration to allow Watson Pharmaceuticals to launch a generic diabetes drug, Mylan said.

PITTSBURGH — Mylan is challenging a federal court decision ordering the Food and Drug Administration to allow Watson Pharmaceuticals to launch a generic diabetes drug, Mylan said.

The generic drug maker said it filed a motion in the U.S. District Court for the District of Columbia Tuesday to stay the court's order, which called on the FDA to let Watson launch a generic version of Takeda's Type 2 diabetes drug Actos (pioglitazone).

October 23, 2012

A federal court has ordered the Food and Drug Administration to approve a generic diabetes drug made by Watson Pharmaceuticals, the drug maker said.

PARSIPPANY, N.J. — A federal court has ordered the Food and Drug Administration to approve a generic diabetes drug made by Watson Pharmaceuticals, the drug maker said.

Watson said the U.S. District Court for the District of Columbia granted summary judgment in favor of Watson, ruling that the FDA would have to approve its generic version of Takeda's Actos (pioglitazone hydrochloride) tablets in the 15-mg, 30-mg and 45-mg strengths.

September 14, 2012

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 29, 2012

Eli Lilly has ceased ongoing clinical studies of an investigational treatment for schizophrenia.

INDIANAPOLIS — Eli Lilly has ceased ongoing clinical studies of an investigational treatment for schizophrenia.

The drug maker said that after recently conducting an independent futility analysis, it concluded that the second of Lilly's two pivotal studies "was unlikely to be positive in its primary efficacy endpoint if enrolled to completion." Additionally, the recently completed phase-2 study, which investigated pomaglumetad methionil (also known as mGlu2/3) as an adjunctive treatment with atypical antipsychotics, did not meet its primary endpoint.

August 27, 2012

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.

August 17, 2012

Ranbaxy Labs has launched an authorized generic version of a diabetes drug made by Takeda Pharmaceutical, Ranbaxy said Friday.

PRINCETON, N.J. — Ranbaxy Labs has launched an authorized generic version of a diabetes drug made by Takeda Pharmaceutical, Ranbaxy said Friday.

Ranbaxy announced the launch, through subsidiary Ranbaxy Pharmaceuticals and under an agreement with Takeda, of pioglitazone hydrochloride tablets, an authorized generic version of Takeda's Actos. An authorized generic is a branded drug marketed at a reduced price under its generic name, typically by a third-party company operating under contract with the original branded drug's manufacturer.

August 17, 2012

Teva Pharmaceutical Industries announced the launch of an authorized generic of a Type 2 diabetes drug.

JERUSALEM — Teva Pharmaceutical Industries announced the launch of an authorized generic of a Type 2 diabetes drug.

The company launched pioglitazone hydrochloride tablets in the 15-mg, 30-mg and 45-mg strengths. The drug is a generic version of Takeda Pharmaceuticals' Actos.

Annual sales of Actos in the United States were approximately $2.7 billion for the 12-month period ended in June, according to IMS sales data.

August 15, 2012

Watson Pharmaceuticals is suing the Food and Drug Administration, alleging that an agency decision would improperly delay its release of a generic drug for diabetes, the company said Wednesday.

PARSIPPANY, N.J. — Watson Pharmaceuticals is suing the Food and Drug Administration, alleging that an agency decision would improperly delay its release of a generic drug for diabetes, the company said Wednesday.

August 9, 2012

The Food and Drug Administration has approved a new drug for treating a rare type of leukemia, the agency said Thursday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating a rare type of leukemia, the agency said Thursday.

The FDA approved South San Francisco, Calif.-based Talon Therapeutics' Marqibo (vincristine sulfate liposome), an injectable drug for Philadelphia chromosome-negative acute lymphoblasic leukemia, or Ph-negative ALL.

August 7, 2012

A biotech drug made by Eli Lilly for osteoporosis appeared no more or less effective than a pharmaceutical drug available as a generic in treating women with related bone fractures, but was more effective in some other measures, according to results of a late-stage clinical trial released Tuesday.

INDIANAPOLIS — A biotech drug made by Eli Lilly for osteoporosis appeared no more or less effective than a pharmaceutical drug available as a generic in treating women with related bone fractures, but was more effective in some other measures, according to results of a late-stage clinical trial released Tuesday.

July 25, 2012

Sagent Pharmaceuticals has launched a generic antibiotic, the company said.

SCHAUMBURG, Ill. — Sagent Pharmaceuticals has launched a generic antibiotic, the company said.

The generic drug maker announced the launch of oxacillin for injection. The drug is a semi-synthetic penicillin used to treat infections caused by penicillinase-producing staphylococci bacteria that have demonstrated susceptibility to the drug.

The drug had sales of $29 million during the 12-month period ended in May, according to IMS Health.

July 16, 2012

A subsidiary of Par Pharmaceutical Cos. acquired earlier this year has received its first Food and Drug Administration approval.

WOODCLIFF LAKE, N.J. — A subsidiary of Par Pharmaceutical Cos. acquired earlier this year has received its first Food and Drug Administration approval.

Par said Par Formulations received approval from the FDA for labetalol hydrochloride tablets in the 100-mg, 200-mg and 300-mg strengths. The drug, a generic version of Prometheus Labs' Trandate, is used to treat hypertension.

Par acquired Par Formulations, formerly the Chennai, India-based drug maker Edict Pharmaceuticals, in February 2012.

July 9, 2012

The Food and Drug Administration has approved a drug made by Eli Lilly and Bristol-Myers Squibb for treating a form of colorectal cancer, the two companies said.

NEW YORK — The Food and Drug Administration has approved a drug made by Eli Lilly and Bristol-Myers Squibb for treating a form of colorectal cancer, the two companies said.

Lilly and Bristol announced the approval of Erbitux (cetuximab) for treating colorectal cancer that is KRAS mutation-negative, expresses the epidermal growth factor receptor and has spread to other parts of the body, also known as metastasis. The drug is approved for use alongside a chemotherapy combination containing irinotecan, 5-fluorouracil and leucovorin, also known as FOLFIRI.

July 6, 2012

Eli Lilly announced that it has met Food and Drug Administration requirements for pediatric exclusivity for its antidepressant medication.

INDIANAPOLIS — Eli Lilly announced that it has met Food and Drug Administration requirements for pediatric exclusivity for its antidepressant medication.

Based on this decision by the FDA, Lilly has gained an additional six months of U.S. market exclusivity for Cymbalta (duloxetine hydrochloride), which now will expire in December 2013.

July 2, 2012

Bristol-Myers Squibb is acquiring Amylin Pharmaceuticals, the drug maker said Friday.

NEW YORK — Bristol-Myers Squibb is acquiring Amylin Pharmaceuticals, the drug maker said Friday.

Bristol announced that it would acquire Amylin for $5.3 billion, or $31 per share. The total value of the acquisition is about $7 billion, including $1.7 billion in Amylin's contractual payment and debt obligations.