Content about Novartis

June 4, 2012
Bayer gastrointestinal cancer drug extends progression-free survival in trial

An experimental drug made by Bayer HealthCare extended the length of time that patients with gastrointestinal tumors survived without their disease getting worse, according to results of a late-stage clinical trial released Monday.

WAYNE, N.J. — An experimental drug made by Bayer HealthCare extended the length of time that patients with gastrointestinal tumors survived without their disease getting worse, according to results of a late-stage clinical trial released Monday.

May 21, 2012
Dr. Reddy's launches heartburn treatment

Dr. Reddy's Labs has launched a generic version of a popular over-the-counter drug for treating heartburn, the company said Monday.

HYDERABAD, India — Dr. Reddy's Labs has launched a generic version of a popular over-the-counter drug for treating heartburn, the company said Monday.

Dr. Reddy's announced the launch of lansoprazole delayed-release capsules in the 15-mg strength in pack sizes of 14, 28 and 42. The drug is a generic version of Novartis Consumer Health's Prevacid 24 HR capsule brand, which had sales of $115 million during the 12-month period ended in March, according to SymphonyIRI InfoScan Reviews.

May 18, 2012
Perrigo launches store-brand Prevacid 24HR

Perrigo on Friday announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug application for lansoprazole capsules in the 15-mg strength.

ALLEGAN, Mich. — Perrigo on Friday announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug application for lansoprazole capsules in the 15-mg strength. The capsules are a generic equivalent of Novartis' Prevacid 24HR capsules.

Sales for Prevacid OTC were approximately $220 million, Perrigo reported.

Interested in this topic? Sign up for our weekly Collaborative Care e-newsletter.

May 11, 2012
Amgen offers testimony at FDA biosimilars hearing

Biotech drug maker Amgen has joined the list of companies offering testimony at a Food and Drug Administration hearing on biosimilars Friday.

THOUSAND OAKS, Calif. — Biotech drug maker Amgen has joined the list of companies offering testimony at a Food and Drug Administration hearing on biosimilars Friday.

May 9, 2012
Sandoz to testify at FDA biosimilars hearing

The Food and Drug Administration should apply consistent regulatory standards across all biologics, Sandoz plans to state Friday in testimony at an FDA public hearing on draft guidances related to the development of biosimilars.

HOLZKIRCHEN, Germany — The Food and Drug Administration should apply consistent regulatory standards across all biologics, Sandoz plans to state Friday in testimony at an FDA public hearing on draft guidances related to the development of biosimilars.

May 2, 2012
Sandoz acquires Fougera for $1.5 billion

Novartis' generics division has acquired Fougera Pharmaceuticals, the company said Wednesday.

BASEL, Switzerland — Novartis' generics division has acquired Fougera Pharmaceuticals, the company said Wednesday.

Sandoz announced the acquisition of Melville, N.Y.-based Fougera for $1.525 billion in cash. Fougera specializes in generic dermatology drugs, and Sandoz said the acquisition would make it the world's largest company in the space.

April 27, 2012
FDA approves Novartis drug for tumors in patients with rare genetic disease

A drug made by Novartis has received approval from the Food and Drug Administration to treat benign kidney tumors related to tuberous sclerosis complex.

EAST HANOVER, N.J. — A drug made by Novartis has received approval from the Food and Drug Administration to treat benign kidney tumors related to tuberous sclerosis complex.

The FDA approved Afinitor (everolimus) tablets for treating the tumors, known as renal angiomyolipomas, in adults with TSC who don't require surgery. The drug already was approved to treat brain tumors known as subependymal giant cell astrocytoma, or SEGA, in patients with TSC.

April 13, 2012
Mylan launches fluvastatin capsules

The Food and Drug Administration has approved a generic drug for lipid disorders made by Mylan, the company said Friday.

PITTSBURGH — The Food and Drug Administration has approved a generic drug for lipid disorders made by Mylan, the company said Friday.

Mylan announced the approval and launch of fluvastatin capsules in the 20-mg and 40-mg strengths, a generic version of Novartis' Lescol. The drug is used to treat hypercholesterolemia and mixed dyslipidemia, as well as prevention of cardiovascular disease.

The drug had sales of $27.9 million in 2011, according to IMS Health.

March 20, 2012
Novartis launches Arcapta Neohaler

Novartis has launched a new treatment for chronic obstructive pulmonary disease, the drug maker said Monday.

EAST HANOVER, N.J. — Novartis has launched a new treatment for chronic obstructive pulmonary disease, the drug maker said Monday.

Novartis Pharmaceuticals, the U.S. division of the Swiss drug manufacturer, announced the launch of Arcapta Neohaler (indacaterol inhalation powder) in the 75-mcg strength. The Food and Drug Administration approved the drug last July.

March 16, 2012
Patients taking oral cancer drugs may risk drug interactions, study finds

Pills for treating cancer have created numerous alternatives to spending hours in a clinic or at home receiving chemotherapy infusions, but risks of drug interactions remain, according to a new survey by the research arm of pharmacy benefit manager Medco Health Solutions.

WASHINGTON — Pills for treating cancer have created numerous alternatives to spending hours in a clinic or at home receiving chemotherapy infusions, but risks of drug interactions remain, according to a new survey by the research arm of pharmacy benefit manager Medco Health Solutions.

February 28, 2012
Report: GSK recalls blood-pressure drug made at Novartis plant

GlaxoSmithKline has recalled nearly 400,000 bottles of a hypertension drug that were distributed in the United States, according to published reports.

NEW YORK — GlaxoSmithKline has recalled nearly 400,000 bottles of a hypertension drug that were distributed in the United States, according to published reports.

Reuters Health reported that GSK was recalling 394,230 bottles of its DynaCirc CR after the drug's manufacturer, Novartis, reported inconsistent packaging practices. The generic drug is manufactured at a Novartis plant in Lincoln, Neb.

No adverse events were reported, GSK was quoted as saying, but the drug maker elected to put forth a recall as a precautionary measure.

February 22, 2012
Novartis to pay $440 million for hepatitis C drug

Novartis plans to pay up to $440 million for rights to a drug for treating hepatitis C made by Enanta Pharmaceuticals, Enanta said.

WATERTOWN, Mass. — Novartis plans to pay up to $440 million for rights to a drug for treating hepatitis C made by Enanta Pharmaceuticals, Enanta said.

Enanta said it had made a licensing agreement with the Swiss drug maker for the worldwide development, manufacturing and commercialization of the drug EDP-239, which works by inhibiting NS5A, a protein that is key to the virus' replication.

February 17, 2012
ReportersNotebook — Chain Pharmacy, 2/27/12

The Food and Drug Administration has approved a drug made by Merck for Type 2 diabetes, the drug maker said. Merck announced the approval of Janumet XR (sitagliptin and metformin hydrochloride) extended-release tablets as a once-daily treatment for the disease.


SUPPLIER NEWS — The Food and Drug Administration has approved a drug made by Merck for Type 2 diabetes, the drug maker said. 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
FDA approves new indication for Novartis' Gleevec

The Food and Drug Administration has approved a drug made by Novartis that is designed to prevent tumors in the gastrointestinal tract from recurring after surgical removal, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Novartis that is designed to prevent tumors in the gastrointestinal tract from recurring after surgical removal, the agency said.

The FDA approved Novartis' Gleevec (imatinib) for adults who have had gastrointestinal stromal tumors, or GIST, removed. The drug was specifically approved for people whose tumors are known as CD117-positive, which includes 95% of all GIST tumors.

The drug was originally approved in 2001 for a type of leukemia.

January 26, 2012
Federal court clears way for Watson, Amphastar to launch generic version of Lovenox

A federal court has stopped an injunction that would have prevented drug maker Watson Pharmaceuticals and partner company Amphastar Pharmaceuticals from marketing or selling a generic version of a blood-thinning drug.

PARSIPPANY, N.J. — A federal court has stopped an injunction that would have prevented drug maker Watson Pharmaceuticals and partner company Amphastar Pharmaceuticals from marketing or selling a generic version of a blood-thinning drug.

January 25, 2012
NARB upholds Advil's challenge of Excedrin's faster-relief claims

The National Advertising Review Board on Tuesday recommended that Novartis Consumer Health discontinue advertising claims that the company’s Excedrin Extra Strength product starts relieving headache pain faster than Advil.

NEW YORK — The National Advertising Review Board on Tuesday recommended that Novartis Consumer Health discontinue advertising claims that the company’s Excedrin Extra Strength product starts relieving headache pain faster than Advil.

The claims at issue were initially challenged before the National Advertising Division of the Council of Better Business Bureaus by Pfizer Consumer Healthcare, makers of Advil.

January 19, 2012
Sandoz starts two late-stage biosimilar trials

Drug maker Sandoz has started two late-stage clinical trials of biosimilar drugs for treating cancer patients undergoing chemotherapy, the company said Thursday, saying the studies were meant to support the drugs' eventual marketing in the United States.

HOLZKIRCHEN, Germany — Drug maker Sandoz has started two late-stage clinical trials of biosimilar drugs for treating cancer patients undergoing chemotherapy, the company said Thursday, saying the studies were meant to support the drugs' eventual marketing in the United States.

January 9, 2012
Endo addresses possible short-term supply of Opana ER, other drugs

Endo Pharmaceuticals announced a short-term supply constraint of analgesic products, including Opana ER, due to the temporary shutdown of a manufacturing facility operated by Novartis Consumer Health.

CHADDS FORD, Pa. — Endo Pharmaceuticals announced a short-term supply constraint of analgesic products, including Opana ER, due to the temporary shutdown of a manufacturing facility operated by Novartis Consumer Health.

January 9, 2012
Novartis Consumer Health issues voluntary recall of certain OTCs sold in the United States

Following the recent voluntary suspension of operations and shipments from its Lincoln, Neb.-based facility, Novartis Consumer Health announced a voluntary recall of some of its over-the-counter products sold in the United States.

BASEL, Switzerland — Following the recent voluntary suspension of operations and shipments from its Lincoln, Neb.-based facility, Novartis Consumer Health announced a voluntary recall of some of its over-the-counter products sold in the United States.

The company said it is voluntarily recalling all lots of select bottle packaging configurations from retailers of Excedrin and NoDoz products with expiration dates of Dec. 20, 2014 or earlier, in addition to Bufferin and Gas-X Prevention products with expiration dates of Dec. 20, 2013 or earlier.

January 6, 2012
Sandoz launches authorized generic shampoo for severe scalp psoriasis

Sandoz has launched a shampoo used to treat severe scalp psoriasis, the generic drug maker said.

PRINCETON, N.J. — Sandoz has launched a shampoo used to treat severe scalp psoriasis, the generic drug maker said.

Sandoz announced the introduction of clobetasol propionate shampoo in the 0.05% strength, an authorized generic version of Galderma Labs' Clobex. An authorized generic drug is a branded drug sold under its generic name, usually by a third-party company at a reduced price.

Various versions of the shampoo had sales of about $54.9 million during the 12-month period ended in October 2011, according to IMS Health.

 

January 4, 2012
FDA approves Actavis ADHD drug

The Food and Drug Administration has approved a generic version of a drug for attention deficit hyperactivity disorder made by Actavis, the drug maker said Wednesday.

MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic version of a drug for attention deficit hyperactivity disorder made by Actavis, the drug maker said Wednesday.

December 20, 2011
Apothecary Shops distributes GlowCap in pilot program

Specialty pharmacy provider The Apothecary Shops is encouraging medication adherence with a cap for pill containers that cues patients with lights and sounds, the company said.

PHOENIX — Specialty pharmacy provider The Apothecary Shops is encouraging medication adherence with a cap for pill containers that cues patients with lights and sounds, the company said.

December 13, 2011
HHS, Novartis celebrate opening of state-of-the-art, stateside vaccine facility

The Department of Health and Human Services on Monday announced that the first U.S. facility to use a faster and more flexible technology to make influenza vaccine was dedicated as part of an initiative that could provide vaccine supplies sooner in an influenza pandemic.

WASHINGTON — The Department of Health and Human Services on Monday announced that the first U.S. facility to use a faster and more flexible technology to make influenza vaccine was dedicated as part of an initiative that could provide vaccine supplies sooner in an influenza pandemic.

December 5, 2011
ReportersNotebook — Chain Pharmacy, 12/12/11

Following the settlement of a patent-litigation suit with Swiss drug maker Novartis over the patch Vivelle-Dot (estradiol transdermal system), a drug for treating symptoms of menopause, Mylan said it had received a patent license to begin selling its version of the drug in December 2013.


SUPPLIER NEWS — Following the settlement of a patent-litigation suit with Swiss drug maker Novartis over the patch Vivelle-Dot (estradiol transdermal system), a drug for treating symptoms of menopause, Mylan said it had received a patent license to begin selling its version of the drug in December 2013.


The Pittsburgh-based generic drug maker was the first to file for regulatory approval of the drug with the Food and Drug Administration, and as such will be entitled to 180 days of 
market exclusivity.


November 21, 2011
Mylan granted license to market generic menopause drug

Mylan will begin selling a generic drug for treating symptoms of menopause in two years, the company said Monday.

PITTSBURGH — Mylan will begin selling a generic drug for treating symptoms of menopause in two years, the company said Monday.

Following the settlement of a patent-litigation suit with Swiss drug maker Novartis over the patch Vivelle-Dot (estradiol transdermal system), Mylan said it had received a patent license to begin selling its version of the drug in December 2013.