Content about Pfizer

SOUTH SAN FRANCISCO, Calif. — The Food and Drug Administration has approved a drug for a type of lung cancer.

Roche subsidiary Genentech and the U.S. subsidiary of Japan's Astellas Pharma announced the approval of Tarceva (erlotinib) for advanced non-small cell lung cancer whose tumors have mutations that activate the epidermal growth factor receptor. The FDA also approved a test to detect the mutation.

The drug was already approved for advanced NSCLC that did not exhibit the mutation.

ALLEGAN, Mich. — There is as much as $10 billion in branded pharmaceutical sales that could make the switch from prescription-only to over-the counter in the next five years, suggested Joseph Papa, Perrigo chairman, CEO and president, to analysts on Tuesday. And as much as $5 billion in the next three years. 

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has approved a new drug made by Merck for treating high cholesterol, the drug maker said.

Merck announced the approval of Liptruzet (ezetimibe and atorvastatin). The drug combines two preexisting cholesterol drugs: ezetimibe, which Merck markets under the brand name Zetia, and atorvastatin, which Pfizer markets under the name Lipitor. Both drugs are available as generics, but because Liptruzet is a novel combination of them, it required FDA approval as a new drug.

HYDERABAD — The Food and Drug Administration has approved two generic drugs made by Aurobindo Pharma, the drug maker said.

The company announced Tuesday the approval of quinapril tablets in the 5-mg, 10-mg, 20-mg and 40-mg strengths. The drug is a generic version of Pfizer's Accupril and is used to treat high blood pressure. Various versions of the drug had sales of about $49 million during the 12-month period ending in September, according to IMS Health.

BASKING RIDGE, N.J. — The Foundation for Health Smart Consumers has announced a major expansion of its smoking cessation initiative through the Inspire Program, which will launch at the annual Retail Clinician Education Congress held in May in Las Vegas. The initial phase of Inspire will continue through 2014.

MADISON, N.J. — Pfizer Consumer Healthcare on Thursday launched its Advil Relief in Action campaign in support of both Habitat for Humanity and Wounded Warrior Project.

Beginning May 1, a portion of the price of participating Advil bottles will go to Habitat for Humanity International and Wounded Warrior Project. The Advil Relief in Action program will also be on-site at Habitat for Humanity builds and in conjunction with Wounded Warrior Project at Tough Mudder events.

NAPLES, Fla. — The Consumer Healthcare Products Association on Wednesday officially elected James Mackey, SVP U.S. region head for Merck Consumer Care, as the association's chairman. Paul Sturman, president and general manager Pfizer Consumer Healthcare, will serve as immediate past chairman. 

PRINCETON, N.J. — Ranbaxy Labs will market a drug for depression under an agreement with another company, the drug maker said Tuesday.

Ranbaxy said it had entered an in-licensing agreement with Alembic Pharmaceuticals to market desvenlafaxine base extended-release tablets. Alembic is the sponsor of a new drug application filed with the Food and Drug Administration for the drug, which is bioequivalent to Pfizer's Pristiq. Pristiq had sales of $590 million during the 12-month period that ended in January.

Alabama's Supreme Court ruled in January that brand-name drug companies could be sued if patients suffer complications from generic versions of their medicines, according to published reports. According to the New York Times, an Alabama man named Danny Weeks claimed he developed tardive dyskinesia after taking generic versions of Pfizer's acid reflux drug Reglan (metoclopramide). Pfizer acquired rights to the drug when it bought Wyeth in 2009, and generic drug makers Teva and Actavis, now owned by Watson, make generic versions.

NEW YORK — Drug maker Ranbaxy Labs has started producing the ingredients for a cholesterol drug while working with the Food and Drug Administration to fix manufacturing issues that led to the recall in November 2012 of several batches of the drug.

The Indian drug maker said it had initiated corrective and preventive actions, or CAPA, as it prepared to resume supplies of generic atorvastatin calcium tablets to the U.S. market. The drug is a generic version of Pfizer's Lipitor, and Ranbaxy became the first company to market a generic version in November 2011.

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).