Content about Novartis

September 21, 2012

The Food and Drug Administration has approved a blood pressure medication made by Mylan.

PITTSBURGH — The Food and Drug Administration has approved a blood pressure medication made by Mylan.

The drug maker announced Friday the approval of valsartan and hydrochlorothiazide tablets in the 80-mg/12.5-mg, 160-mg/12.5-mg, 160-mg/25-mg, 320-mg/12.5-mg and 320-mg/25-mg strengths.

The drug, a generic version of Novartis' Diovan HCT, is used to treat high blood pressure, or hypertension, in patients who can't control their blood pressure with one drug or who are starting therapy and need multiple drugs.

September 18, 2012

Over the last few years of DSN’s coverage of the impending patent cliff and how it would affect the generic drug industry, IMS Health VP industry relations Doug Long predicted that the gradual commoditization of primary care drugs — long the lifeblood of generic drug makers — would lead to consolidation of the industry.


Over the last few years of DSN’s coverage of the impending patent cliff and how it would affect the generic drug industry, IMS Health VP industry relations Doug Long predicted that the gradual commoditization of primary care drugs — long the lifeblood of generic drug makers — would lead to consolidation of the industry.


September 12, 2012

SoloHealth on Wednesday named Tim Kiss to serve as VP marketing — a new position at SoloHealth — as the company prepares for its nationwide rollout of the SoloHealth Station consumer kiosk this fall.

 ATLANTA — SoloHealth on Wednesday named Tim Kiss to serve as VP marketing — a new position at SoloHealth — as the company prepares for its nationwide rollout of the SoloHealth Station consumer kiosk this fall. SoloHealth also named Dan Bonert to VP advertising sales, promoted Eric Hoell to VP operations and promoted Stephen Kendig to EVP and chief commercial officer.

September 6, 2012

A panel of Food and Drug Administration experts is recommending that the agency approve an experimental drug for cystic fibrosis made by Novartis, the Swiss drug maker said.

EAST HANOVER, N.J. — A panel of Food and Drug Administration experts is recommending that the agency approve an experimental drug for cystic fibrosis made by Novartis, the Swiss drug maker said.

September 4, 2012

The Food and Drug Administration has approved a new formulation of a cancer drug made by Novartis for a type of brain cancer in children, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new formulation of a cancer drug made by Novartis for a type of brain tumor in children, the agency said.

The FDA announced the approval of Afinitor Disperz (everolimus) tablets for oral suspension to treat a rare brain tumor called subependymal giant-cell astrocytoma, or SEGA. The agency said Afinitor Disperz, a new dosage form of the drug Afinitor, is the first pediatric-specific dosage form for a pediatric tumor to receive FDA approval.

August 17, 2012

Procter & Gamble’s Prilosec OTC still is the best-selling antacid on the market, with more than $252.7 million in annual sales for the 52 weeks ended July 8 across food, drug and mass (excluding Walmart), followed by fellow proton-pump inhibitor Novartis’ Prevacid 24HR ($104.1 million).


Procter & Gamble’s Prilosec OTC still is the best-selling antacid on the market, with more than $252.7 million in annual sales for the 52 weeks ended July 8 across food, drug and mass (excluding Walmart), followed by fellow proton-pump inhibitor Novartis’ Prevacid 24HR ($104.1 million).


Both of those antacid heavy hitters are losing dollar share to their generic-
equivalent competitors, however, leaving GlaxoSmithKline’s venerable Tums brand as the largest growth brand within antacids ($91.3 million in sales, up 2.5%).


August 14, 2012

The Food and Drug Administration has approved the formulation for the 2012-2013 flu vaccine, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved the formulation for the 2012-2013 flu vaccine, the agency said Monday.

The agency's approval is for all six licensed flu vaccines for the 2012-2013 season: Afluria, made by CSL; Fluarix, made by GlaxoSmithKline; FluLaval, made by ID Biomedical; FluMist, made by MedImmune Vaccines; Fluvirin, made by Novartis; and Fluzone, made by Sanofi.

August 13, 2012

An experimental drug therapy under development by Novartis for liver transplant patients appears to provide similar efficacy and better kidney function, compared with a drug made by Astellas Pharma, according to results of a late-stage clinical trial.

EAST HANOVER, N.J. — An experimental drug therapy under development by Novartis for liver transplant patients appears to provide similar efficacy and better kidney function, compared with a drug made by Astellas Pharma, according to results of a late-stage clinical trial.

A phase-3 study published in the American Journal of Transplantation found that patients taking RAD001 (everolimus) with a reduced dose of Astellas' Prograf (tacrolimus) experienced equal efficacy and superior kidney function to patients taking Prograf alone.

August 6, 2012

Sandoz has launched a generic version of a topical medication used to treat psoriasis, the company said.

PRINCETON, N.J. — Sandoz has launched a generic version of a topical medication used to treat psoriasis, the company said.

Sandoz, the generics arm of Swiss drug maker Novartis, announced the launch of calcipotriene cream in the 0.005% strength, calling it the first generic version of Leo Pharma's Dovonex.

Dovonex had sales of about $118.8 million during the 12-month period ended in May, according to IMS Health.

July 23, 2012

The Food and Drug Administration has approved a new use for a Novartis cancer drug.

EAST HANOVER, N.J. — The Food and Drug Administration has approved a new use for a Novartis cancer drug.

The drug maker said Friday that the FDA had approved Afinitor (everolimus) combined with exemestane for postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer who have failed treatment with letrozole or anastrozole.

July 18, 2012

Teva Pharmaceuticals has introduced a generic drug for treating attention deficit hyperactivity disorder, the company said.

NORTH WALES, Pa. — Teva Pharmaceuticals has introduced a generic drug for treating attention deficit hyperactivity disorder, the company said.

Teva announced the launch of methylphenidate hydrochloride extended-release capsules in the 20-mg, 30-mg and 40-mg strength. The drug, a generic version of Novartis' Ritalin, is available in 100-pill bottles.

June 21, 2012

While no one can predict illness rates for the upcoming 2012-2013 cough, cold and flu season — unless maybe you’re reading out of the book of Nostradamus — one thing you can bank on is this: It’s going to be one volatile season.


While no one can predict illness rates for the upcoming 2012-2013 cough, cold and flu season — unless maybe you’re reading out of the book of Nostradamus — one thing you can bank on is this: It’s going to be one volatile season.


June 4, 2012

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 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 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.


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May 11, 2012

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

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

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

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

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 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

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

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 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

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.