Content about Eisai

February 20, 2014

Kremers Urban Pharmaceuticals announced the launch of rabeprazole sodium delayed-release tablets, which are used to treat gastroesophageal reflux disease in adults and adolescents.

PRINCETON, N.J. — Kremers Urban Pharmaceuticals, a subsidiary of UCB, announced the launch of rabeprazole sodium delayed-release tablets. The drug is used to treat gastroesophageal reflux disease in adults and adolescents, according to the FDA.

The product is the bioequivalent to Aciphex from Eisai. Kremers Urban rabeprazole sodium delayed-release tablets are available in 20-mg strength in both 30- and 90-count bottles.

January 2, 2014

Drug maker Eisai will make a new epilepsy drug available in the United States starting on Monday, the company said.

WOODCLIFF LAKE, N.J. — Drug maker Eisai will make a new epilepsy drug available in the United States starting on Monday, the company said Thursday.

December 17, 2013

Mylan and a partnering company will be able to sell a generic version of a cancer drug starting in summer 2015, under a court settlement announced Tuesday.

PITTSBURGH — Mylan and a partnering company will be able to sell a generic version of a cancer drug starting in summer 2015, under a court settlement announced Tuesday.

Mylan said that it and Banner Pharmacaps had reached a settlement agreement with Eisai and a subsidiary of Valeant Pharmaceuticals International to resolve a lawsuit filed over their generic version of Targretin (bexarotene) capsules in the 75-mg strength. The drug is used to treat certain forms of T-cell lymphoma.

November 11, 2013

Indian drug maker Lupin has launched its generic version of a drug used to treat gastroesophageal reflux disease, the company said Monday.

BALTIMORE — Indian drug maker Lupin has launched its generic version of a drug used to treat gastroesophageal reflux disease, the company said Monday.

Lupin announced the launch of rabeprazole sodium extended-release tablets in the 20-mg strength, a generic version of Eisai's Aciphex. The Food and Drug Administration approved generic versions of Aciphex made by six companies on Friday.

Aciphex had sales of about $864.3 million during the 12-month period that ended in June, according to IMS Health.

 

November 11, 2013

Mylan has launched its generic version of a drug used to treat gastroesophageal reflux disease, the U.S.-based generic drug maker said Monday.

PITTSBURGH — Mylan has launched its generic version of a drug used to treat gastroesophageal reflux disease, the U.S.-based generic drug maker said Monday.

Mylan announced the launch of rabeprazole sodium extended-release tablets in the 20-mg strength, a generic version of Eisai's Aciphex. The Food and Drug Administration approved generic versions of Aciphex made by six companies on Friday.

Aciphex had sales of about $830.1 million during the 12-month period that ended in September, according to IMS Health. 

November 8, 2013

Drug maker Eisai has launched a new version of a drug used to treat gastroesophageal reflux disease, the company said Friday.

WOODCLIFF LAKE, N.J. — Drug maker Eisai has launched a new version of a drug used to treat gastroesophageal reflux disease, the company said Friday.

Eisai announced the availability of Aciphex Sprinkle delayed-release capsules in the 5-mg and 10-mg strengths. The Food and Drug Administration approve the drug in March.

Aciphex Sprinkle capsules, which are approved for use in children aged 1 to 11 for up to 12 weeks, are designed to be broken open and sprinkled on soft food or liquid.

 

November 8, 2013

The Food and Drug Administration has approved six generic versions of a drug used to treat gastroesophageal reflux disease, or GERD, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved six generic versions of a drug used to treat gastroesophageal reflux disease, or GERD, the agency said Friday.

The FDA announced the approval of the first generic versions of Eisai's Aciphex (rabeprazole sodium) delayed-release tablets for patients aged 12 and older. The generic products are made by Dr. Reddy's Labs, Kremers Urban Pharmaceuticals, Lupin Pharmaceuticals, Mylan Pharmaceuticals, Teva Pharmaceuticals USA and Torrent Pharmaceuticals.

September 12, 2013

Drug maker Eisai has launched a new support and savings program for patients using a weight-loss drug that it makes.

WOODCLIFF LAKE, N.J. — Drug maker Eisai has launched a new support and savings program for patients using a weight-loss drug that it makes.

The drug maker announced Thursday the availability of Believe Everyday Support for patients using Belviq (lorcaserin hydrochloride), which includes a customizable online portal designed to help patients reach their weight loss goals and sustain their efforts.

September 5, 2013

Japanese drug maker Otsuka Pharmaceutical Co. is buying U.S.-based Astex Pharmaceuticals for $886 million, Otsuka said Thursday.

TOKYO — Japanese drug maker Otsuka Pharmaceutical Co. is buying U.S.-based Astex Pharmaceuticals for $886 million, Otsuka said Thursday.

Astex, based in Dublin, Calif., uses a drug-discovery system known as fragment-based drug discovery, which enables rapid discovery and development of compounds for target proteins implicated in diseases and works by evaluating binding of target proteins with small molecules through 3D structural analysis. Astex developed and launched the chemotherapy drug Dacogen (decitabine), currently sold by Eisai.

August 15, 2013

Eisai, the U.S. pharmaceutical arm of Tokyo-based Eisai Co., announced the launch of a new website, "Closing the Gap: Obesity Management for Employers," to provide employers with an educational resource for information about obesity management.

WOODCLIFF LAKE, N.J. — Eisai Inc., the U.S. pharmaceutical arm of Tokyo-based Eisai Co. Ltd., announced on Thursday the launch of a new website, "Closing the Gap: Obesity Management for Employers," to provide employers with an educational resource for information about obesity management.

August 8, 2013

Eisai announced that the Food and Drug Administration has granted orphan drug designation to its investigational compound (E7777) for cutaneous T-cell lymphoma.

WOODCLIFF LAKE, N.J. — Eisai Inc., announced today that the U.S. Food and Drug Administration has granted orphan drug designation to its investigational compound (E7777) for cutaneous T-cell lymphoma. E7777 is designed to have an improved purity profile and manufacturing process. It is currently in a pivotal trial intended to support its submission for approval.

July 29, 2013

Dr. Reddy's Labs has launched a generic drug used to treat Alzheimer's disease, the company said.

HYDERABAD, India — Dr. Reddy's Labs has launched a generic drug used to treat Alzheimer's disease, the company said.

The Indian drug maker announced the launch of donepezil hydrochloride tablets in the 23-mg strength, a generic version of Eisai and Pfizer's Aricept. The drug is being launched in 30- and 90-count bottles.

Aricept in the 23-mg strength had sales of about $92.6 million during the 12-month period that ended in May, according to IMS Health.

 

July 9, 2013

The Food and Drug Administration has approved a generic drug for treating Alzheimer's disease, FDA records showed.

SILVER SPRING, Md. — The Food and Drug Administration has approved a generic drug for treating Alzheimer's disease, FDA records showed.

The agency announced the approval of Alvogen's donepezil hydrochloride, a generic version of Aricept, made by Pfizer and Eisai. The generic drug was approved in the 5 mg and 10 mg strengths.

More than 20 other companies also make generic versions of Aricept. The drug is used to treat mild to moderate Alzheimer's, as well as severe forms of the disease.

 

March 27, 2013

The Food and Drug Administration has approved a treatment made by Eisai for gastroesophageal reflux disease in children ages 1 year to 11 years, the drug maker said.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a treatment made by Eisai for gastroesophageal reflux disease in children ages 1 year to 11 years, the drug maker said.

Eisai announced the approval of Aciphex Sprinkle (rabeprazole sodium) delayed-release capsules.

February 28, 2013

Canadian generic drug makers expressed dismay over a new plan to reduce reimbursements for a half-dozen generic medications in most of the country's provinces. According to published reports, a group of premiers had reached a coordinated deal to reduce the prices their governments paid for six generic drugs, hoping to save the provinces nearly $100 million.

Canadian generic drug makers expressed dismay over a new plan to reduce reimbursements for a half-dozen generic medications in most of the country's provinces. According to published reports, a group of premiers had reached a coordinated deal to reduce the prices their governments paid for six generic drugs, hoping to save the provinces nearly $100 million.

February 21, 2013

Valeant Pharmaceuticals has bought rights to a drug used to treat skin cancer from Eisai, the companies said Thursday.

WOODCLIFF LAKE, N.J. — Valeant Pharmaceuticals has bought rights to a drug used to treat skin cancer from Eisai, the companies said Thursday.

Valeant has bought the rights to Targretin (bexarotene) capsules and gel from Eisai for $65 million upfront, plus additional payments based on certain milestones. Under the deal, Eisai has transferred its regulatory approval application to Valeant, which will assume responsibilities for all regulatory obligations associated with the product in the United States. Eisai will retain rights to the drug outside the United States.

February 14, 2013

The Food and Drug Administration has granted special designation to a drug made by Eisai for treating thyroid cancer.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has granted special designation to a drug made by Eisai for treating thyroid cancer.

The drug maker said Thursday that its experimental drug E7080 (lenvatinib) had received orphan drug designation from the FDA for follicular, medullary, anapestic and metastatic or locally advanced papillary thyroid cancer.

January 25, 2013

Canada's provincial and territorial governments have reached a deal that they said would save money on drugs, but that generic drug makers said had left them "disappointed."

NEW YORK — Canada's provincial and territorial governments have reached a deal that they said would save money on drugs, but that generic drug makers said had left them "disappointed."

December 11, 2012

The Food and Drug Administration is allowing a drug made by Eisai for treating gastroesophageal reflux disease to retain its market exclusivity for six months past the original expiration date, the company said.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration is allowing a drug made by Eisai for treating gastroesophageal reflux disease to retain its market exclusivity for six months past the original expiration date, the company said Tuesday.

Eisai said the FDA had granted six more months of exclusivity for the use of Aciphex (rabreprazole sodium) in children, meaning it will lose market exclusivity on Nov. 8, 2013.

December 4, 2012

The Food and Drug Administration will review an acid-reflux drug made by Eisai for use in children, the drug maker said.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration will review an acid-reflux drug made by Eisai for use in children, the drug maker said.

Eisai said the FDA accepted its application for AcipHex delayed-release sprinkle capsules in the 5-mg and 10-mg strengths for healing of gastroesophageal reflux disease, and maintenance of healing of GERD and improvement of symptoms in children ages 1 year to 11 years.

The FDA expects to have the application reviewed by March 27, 2013. The drug is currently approved in the 20-mg strength for adolescents and adults.

October 22, 2012

The Food and Drug Administration has approved a new drug for epilepsy, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for epilepsy, the agency said Monday.

The FDA announced the approval of Eisai's Fycompa (perampanel) tablets to treat partial-onset seizures in patients ages 12 years and older. Partial seizures are the most common type seen in people with epilepsy, according to the FDA.

June 25, 2012

The U.S. pharmaceutical subsidiary of Eisai has promoted one of its executives.

WOODCLIFF LAKE, N.J. — The U.S. pharmaceutical subsidiary of Eisai has promoted one of its executives.

Shaji Procida, who previously served as VP finance of Eisai Inc., has been appointed to serve as VP and CFO. In her elevated role, she will have oversight and responsibility for all of Eisai's financial operations in the United States and also will continue to serve as a member of the company's executive committee. Procida has worked at the drug maker since 1998.

April 30, 2012

Eisai announced that Allen Waxman has joined the company.

WOODCLIFF LAKE, N.J. — Eisai announced that Allen Waxman has joined the company.

Waxman, who has worked at such companies as Kaye Schouler LLP and Pfizer, will serve as SVP and general counsel, where he will be responsible for leading the office of the general counsel and all legal matters for the company in the United States. Waxman also will be a member of the company's executive committee and also will join others in providing leadership for a number of global legal matters for Eisai.

March 7, 2012

The Food and Drug Administration has declined to approve a drug made by Eisai for leukemia in certain elderly patients, the drug maker said.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has declined to approve a drug made by Eisai for leukemia in certain elderly patients, the drug maker said.

Eisai said the FDA delivered it a complete response letter for the chemotherapy drug Dacogen (decitabine) in patients ages 65 years and older with acute myeloid leukemia who are not candidates for induction therapy. The FDA delivers a complete response letter when questions remain about an regulatory application that preclude approval, usually due to insufficient clinical trial data.

February 10, 2012

An expert panel at the Food and Drug Administration has given a thumbs-down to a drug made by Astex Pharmaceuticals and Eisai for which the two had sought approval as a treatment for leukemia.

DUBLIN, Calif. — An expert panel at the Food and Drug Administration has given a thumbs-down to a drug made by Astex Pharmaceuticals and Eisai for which the two had sought approval as a treatment for leukemia.

The FDA's Oncologic Drugs Advisory Committee voted 10-3 with one abstention not to support the risk-benefit profile of Dacogen (decitabine) in certain elderly patients with acute myeloid leukemia. The FDA is not bound by advisory committee votes when deciding whether or not to approve a drug, but usually follows them.