Content about Novartis

WOODCLIFF LAKE, N.J. — Generic drug maker Par Pharmaceutical Cos. has started shipping an authorized generic version of a heart-disease medication made by AstraZeneca.

Par said it had entered into an agreement with AstraZeneca to supply authorized generic Atacand (candesartan cilexetil) and had begun shipping the drug in the 4 mg, 8 mg, 16 mg and 32 mg strengths. Atacand has annual sales of about $113 million, according to IMS Health, and is used to treat certain kinds of heart failure and high blood pressure in children and adults.

NEW YORK — A dramatic jump in the rates of misuse of prescription stimulants over the past four years is linked to lax attitudes on the part of parents, according to a new study, though misuse and abuse of prescription opioids has remained flat.

BASEL, Switzerland — The Food and Drug Administration has approved a drug made by Alcon, the drug maker said.

HYDERABAD, India — Dr. Reddy's Labs has launched zoledronic acid injection in the 5 mg-per-100-mL strength, the Indian generic drug maker Thursday.

The drug, launched following its approval by the Food and Drug Administration, is a generic version of Novartis' Reclast and is used to treat osteoporosis. Reclast had sales of $355 million during the 12-month period that ended in February, according to IMS Health.

NEW YORK — A ruling by India's high court means cheaper generic versions of a cancer drug will remain available in developing countries, according to published reports.

The New York Times reported that the Indian Supreme Court ruled drug companies there could keep making generic versions of Swiss drug maker Novartis' leukemia medication Gleevec (imatinib). According to the Times, generic versions of Gleevec in India cost about $2,500 per year, compared with $70,000 per year for the branded version.

PRINCETON, N.J. — The Food and Drug Administration has approved and launched two generic contraceptives made by Sandoz, the drug maker said.

Sandoz, the generics division of Swiss drug maker Novartis, announced the approval of Estarylla (norgestimate and ethinyl estradiol tablets) and Tri-Estarylla (norgestimate and ethinyl estradiol tablets), generic versions of Johnson & Johnson's Ortho Cyclen and Ortho Tri-Cyclen, respectively. Sandoz said the launches brought the total number of oral contraceptives it has launched since the beginning of 2011 to six.

With private label across analgesics up an estimated 11.3% to $1.7 billion, retailers are going to need to make some tough decisions as two internal analgesic powerhouses — McNeil's Tylenol and Novartis' Excedrin — make their way back onto market after respective recalls. Within internal analgesic tablets, sales of store brand equivalents were up 15% off of a 2011 base of around $1.2 billion. The branded competition also were benefactors — both Pfizer's Advil and Bayer's Aleve generated more than $50 million in incremental sales on top of 2011 sales.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by Bayer HealthCare Pharmaceuticals for treating tumors of the digestive system, the agency said Monday.

The FDA announced the approval of Stivarga (regorafenib) for gastrointestinal stromal tumors that could not be removed through surgery or had spread to other parts of the body and were no longer responding to treatment with Novartis' Gleevec (imatinib) or Pfizer's Sutent (sunitinib).

PRINCETON, N.J. — The Food and Drug Administration has approved a generic antibiotic made by Sandoz, the drug maker said Wednesday.

Sandoz, the generics arm of Swiss drug maker Novartis, announced the approval and launch of clindamycin in 5% dextrose in minibag form, the first generic version of Pfizer's Cleocin Phosphate in Dextrose 5%.

Sales of the branded version were $52.2 million in 2012, according to IMS Health.

SILVER SPRING, Md. — The Food and Drug Administration has approved a Novartis drug for treating leukemia in children.

The FDA said Friday that it approved Gleevec (imatinib) for treating children newly diagnosed with Philadelphia chromosome-positive acute lymphoblastic leukemia, also known as Ph+ ALL.

SCHLIEREN, Switzerland — Cytos Biotechnology will regain rights to an experimental vaccine against nicotine addiction that it had licensed to Novartis, Cytos said Wednesday.

The company said that Novartis would discontinue the project, known as NIC002. Cytos granted Novartis a license for NIC002 in 2007, but phase-2 trial results in October 2009 indicated that the vaccine spurred the development of nicotine-specific antibodies in patients, but did not increase smoking cessation.

WASHINGTON — A federal judge in Washington has dismissed a suit against the FDA brought up by Mylan for withholding approval for the company to sell a generic version of Novartis AG’s heart pill, Diovan.

U.S. District Court Judge John D. Bates said in an opinion filed on Dec. 27, that the FDA did not act “capriciously” when it denied Mylan exclusivity to market its version of Diovan. Bates also said Mylan did not show it suffered “irreparable harm” as a result.