Content about Novartis

November 21, 2012
FDA approves first flu vaccine manufactured by Novartis using cell culture technology

The Food and Drug Administration on Wednesday announced the approval of Novartis' Flucelvax, the first seasonal influenza vaccine licensed in the United States produced using cultured animal cells, instead of fertilized chicken eggs.

SILVER SPRING, Md. — The Food and Drug Administration on Wednesday announced the approval of Novartis' Flucelvax, the first seasonal influenza vaccine licensed in the United States produced using cultured animal cells, instead of fertilized chicken eggs. Flucelvax is approved to prevent seasonal influenza in people ages 18 years and older.

November 15, 2012
Branded generics transform the old into the new

In the classic Arabian Nights tale “Aladdin and the Magic Lamp,” the sorcerer who sold Aladdin the lamp containing the genie attempts to get it back by walking through the town where Aladdin and his wife live disguised as a merchant, trading “new lamps 
for old.” 


In the classic Arabian Nights tale “Aladdin and the Magic Lamp,” the sorcerer who sold Aladdin the lamp containing the genie attempts to get it back by walking through the town where Aladdin and his wife live disguised as a merchant, trading “new lamps 
for old.” 


Rubbing pill bottles isn’t likely to bring forth any genies ready to grant three wishes, but the idea of inputting something old and outputting something shiny and new is sort of the gist behind 
branded generics.


November 15, 2012
Generic drugs compete in game of differentiation

The year 2012 is coming to an end, and it’s been a big year for 
generic drugs.


The year 2012 is coming to an end, and it’s been a big year for 
generic drugs.


November 15, 2012
NewsBytes — Chain Pharmacy, 11/19/12

The Food and Drug Administration has approved a generic drug for leukemia made by a subsidiary of Par Pharmaceutical Cos.


FDA approves Par leukemia drug
WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a generic drug for leukemia made by a subsidiary of Par Pharmaceutical Cos.


Par said Oct. 25 that the FDA had approved Anchen Pharmaceuticals’ tretinoin capsules in the 10-mg strength.


The drug is a generic version of Roche’s Vesanoid, various versions of which have annual sales of about $29 million, according to IMS Health.



 

November 14, 2012
Novartis Consumer launches My Migraine Triggers app

Novartis Consumer Health on Wednesday announced the development of a convenient migraine trigger tracking tool, My Migraine Triggers App, with a neurologist.

PARSIPPANY, N.J. — Novartis Consumer Health on Wednesday announced the development of a convenient migraine trigger tracking tool, My Migraine Triggers App, with a neurologist. The company also partnered with Jordin Sparks, singer, actress and Broadway performer, and Keri Peterson, an internist at Lenox Hill Hospital, on the launch of "Managing Migraines: Know Your Triggers. Know Your Treatment," an educational campaign to raise awareness around the importance of knowing individual migraine triggers. 

November 8, 2012
FDA panel recommends approval for Novartis Cushing's disease drug

A Food and Drug Administration expert panel has voted unanimously in favor of approval for a Novartis drug for a rare endocrine disorder.

EAST HANOVER, N.J. — A Food and Drug Administration expert panel has voted unanimously in favor of approval for a Novartis drug for a rare endocrine disorder.

November 5, 2012
Watson-Actavis latest among generic M&As

In what its president and CEO called a “significant milestone,” Watson Pharmaceuticals announced last month that the U.S. Federal Trade Commission and European Commission had approved its acquisition of Swiss generic drug maker Actavis.

In what its president and CEO called a “significant milestone,” Watson Pharmaceuticals announced last month that the U.S. Federal Trade Commission and European Commission had approved its acquisition of Swiss generic drug maker Actavis. Watson announced the $5.6 billion acquisition of Actavis in April, a deal that is expected to make Watson the third-largest generic drug maker in the world, after Teva Pharmaceutical Industries and Mylan.

October 31, 2012
Sandoz starts phase-3 trial of biosimilar anemia drug

Generic drug maker Sandoz has started a late-stage clinical trial in the United States for a biosimilar treatment for anemia, the company said.

HOLZKIRCHEN, Germany — Generic drug maker Sandoz has started a late-stage clinical trial in the United States for a biosimilar treatment for anemia, the company said.

Sandoz, the generics arm of Swiss drug maker Novartis, said it had started enrolling patients for a phase-3 study of epoetin alfa, a biosimilar version of Epogen and Procrit, made by Amgen and Johnson & Johnson and used to treat anemia associated with chronic kidney disease.

October 26, 2012
Novartis outsources production to bring back top-selling OTC brands to market

Progress at re-opening its manufacturing facility in Lincoln, Neb., has been slow-going, Novartis reported Thursday, but the company has contracted third-party manufacturers to resume production of Excedrin, Lamisil and Triaminic.

 BASEL, Switzerland — Progress at re-opening its manufacturing facility in Lincoln, Neb., has been slow-going, Novartis reported Thursday, but the company has contracted third-party manufacturers to resume production of Excedrin, Lamisil and Triaminic. First shipments to retailers were made in October. 

October 23, 2012
United Therapeutics awaits FDA decision on oral PAH drug as Sandoz seeks generic approval

The Food and Drug Administration is expected to decide at the end of this week whether to approve a new oral drug for pulmonary arterial hypertension made by United Therapeutics.

NEW YORK — The Food and Drug Administration is expected to decide at the end of this week whether to approve a new oral drug for pulmonary arterial hypertension made by United Therapeutics.

October 22, 2012
Watson, Actavis divest more drugs as condition for FTC merger approval

Watson Pharmaceuticals and Actavis will have to divest rights to almost two dozen drugs as a condition for U.S. regulatory approval of their $5.6 billion merger announced earlier this year, according to regulatory documents.

NEW YORK – Watson Pharmaceuticals and Actavis will have to divest rights to almost two dozen drugs as a condition for U.S. regulatory approval of their $5.6 billion merger announced earlier this year, according to regulatory documents.

October 12, 2012
FDA approves Sandoz dermatology drug

The Food and Drug Administration has approved a drug made by Sandoz for treating symptoms of various skin diseases.

PRINCETON, N.J. — The Food and Drug Administration has approved a drug made by Sandoz for treating symptoms of various skin diseases.

Sandoz, the generics arm of Swiss drug maker Novartis, announced the approval of desoximetasone ointment in the 0.25% strength. The drug is a generic version of Taro Pharmaceutical Industries' Topicort and, according to Sandoz, is the first Fougera dermatology product Sandoz has launched since its $1.5 billion acquisition of the company in May 2012.

September 24, 2012
Sandoz launches authorized generic of Diovan HCT

Generic drug maker Sandoz has launched an authorized generic version of a drug used to treat hypertension.

NEW YORK — Generic drug maker Sandoz has launched an authorized generic version of a drug used to treat hypertension.

The generics division of Swiss drug maker Novartis announced the introduction of valsartan and hydrochlorothiazide tablets, a generic version of Novartis' Diovan HCT. Novartis will continue marketing the branded version of the drug, which had sales of $2.3 billion in 2011 together with Diovan (valsartan).

September 21, 2012
FDA approves Mylan hypertension drug

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
Mergers among generics cos. on the rise

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 brings together veteran executive team in preparation for national kiosk launch

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
FDA advisory committee recommends approval for Novartis cystic fibrosis drug

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
FDA approves smaller-dose Afinitor for rare brain tumor in children

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
Generics contend in PPIs

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
FDA approves formulation for 2012-2013 flu vaccines

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
Novartis drug appears effective in liver transplant patients

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 launches generic psoriasis treatment

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
FDA approves Afinitor for advanced breast cancer

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 launches ADHD drug

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
Cough-cold season 
sure to be a volatile one

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.