Content about Pharmaceuticals policy

August 11, 2011

Medicare Part D beneficiaries showed better adherence to their oral diabetes drugs when receiving them by mail order, according to a new study.

IRVINE, Calif. — Medicare Part D beneficiaries showed better adherence to their oral diabetes drugs when receiving them by mail order, according to a new study.

The study, conducted on behalf of Prescription Solutions by OptumRx, the pharmacy benefit management arm of health services company Optum, and published in the Journal of Medical Economics, found that patients using mail-order pharmacy showed adherence rates of 49.7%, compared with 42.8% of those who went to retail pharmacies.

August 10, 2011

The Food and Drug Administration has approved a generic drug for epilepsy.

PISCATAWAY, N.J. — The Food and Drug Administration has approved a generic drug for epilepsy.

Innopharma announced the FDA approval of levetiracetam injection. The drug is a generic version of UCB's Keppra.

Innopharma has a licensing agreement with X-GEN Pharmaceuticals for marketing and distribution of the drug.

August 10, 2011

The Food and Drug Administration has granted tentative approval to a generic cholesterol drug made by Watson Pharmaceuticals, the company said Wednesday.

MORRISTOWN, N.J. — The Food and Drug Administration has granted tentative approval to a generic cholesterol drug made by Watson Pharmaceuticals, the company said Wednesday.

Watson announced the tentative approval of Watson's rosuvastatin zinc tablets in the 5-mg, 10-mg, 20-mg and 40-mg strengths. The drug is a generic version of AstraZeneca's Crestor. Tentative approval means that the drug meets the FDA's conditions for approval, but the agency can't allow it to be marketed because patents covering the branded version have yet to expire.

August 9, 2011

Profits for Endo Pharmaceutical Holdings rose to $54.6 million during second quarter 2011, up 6% from $51.5 million in second quarter 2010, the drug maker said.

CHADDS FORD, Pa. — Profits for Endo Pharmaceutical Holdings rose to $54.6 million during second quarter 2011, up 6% from $51.5 million in second quarter 2010, the drug maker said.

Sales for the quarter were $607.5 million, compared with $396.5 million in second quarter 2010. Sales of branded drugs were $398.3 million, an 8% increase over last year, which the company attributed to better sales of the pain drug Opana ER and the joint pain drug Voltaren Gel.

August 9, 2011

The Food and Drug Administration has approved a generic chemotherapy drug made by Hospira, the drug maker said.

LAKE FOREST, Ill. — The Food and Drug Administration has approved a generic chemotherapy drug made by Hospira, the drug maker said.

Hospira announced the approval of gemcitabine injection in the 200-mg, 1-g and 2-g formulations and plans to launch the drug in September. The drug is a generic version of Eli Lilly's Gemzar.

Various versions of the drug had sales of $750 million in 2010, according to Hospira.

August 9, 2011

A bill awaiting a signature or veto from New York governor Andrew Cuomo that would restrict home delivery of chronic medications has attracted criticism from the Federal Trade Commission and the pharmacy benefit manager lobby.

WASHINGTON — A bill awaiting a signature or veto from New York governor Andrew Cuomo that would restrict home delivery of chronic medications has attracted criticism from the Federal Trade Commission and the pharmacy benefit manager lobby.

In a letter to New York state Sen. James Seward responding to the senator's request for comments, the FTC said New York Assembly Bill 5502-B would harm consumers and raise the prices of drugs while reducing access to them.

August 9, 2011

Hetero is at the center of two patent litigation suits for attempting to market generic versions of Viagra and Nexium, according to published reports.

NEW YORK — Hetero is at the center of two patent litigation suits for attempting to market generic versions of Viagra and Nexium, according to published reports.

August 5, 2011

Medicare Part D prescription drug plan premiums will cost beneficiaries roughly $30 in 2012, according to data from the Centers for Medicare and Medicaid Services.

WASHINGTON — Medicare Part D prescription drug plan premiums will cost beneficiaries roughly $30 in 2012, according to data from the Centers for Medicare and Medicaid Services.

The Pharmaceutical Care Management Association, a trade group representing pharmacy benefit managers, heralded the figure, saying it confirmed the success of Medicare Part D plans in delivering savings.

August 4, 2011

The Food and Drug Administration has reorganized the Office of Generic Drugs in an effort to improve efficiency, according to an internal memo.

SILVER SPRING, Md. — The Food and Drug Administration has reorganized the Office of Generic Drugs in an effort to improve efficiency, according to an internal memo.

The new organizational scheme will add a new division to the bioequivalence program called Division of Bioequivalence II and a new chemistry division, Division of Chemistry IV.

August 3, 2011

Topco, a member-owned cooperative serving the food industry, recently kicked off an initiative substituting its TopCare-branded over-the-counter medicines for the equivalent prescription pharmaceutical, where appropriate, in an effort to save patient dollars and promote the TopCare brand.

SKOKIE, Ill. — Topco, a member-owned cooperative serving the food industry, recently kicked off an initiative substituting its TopCare-branded over-the-counter medicines for the equivalent prescription pharmaceutical, where appropriate, in an effort to save patient dollars and promote the TopCare brand.

August 2, 2011

The Food and Drug Administration has granted orphan drug designation to a chemotherapy drug made by Merrimack Pharmaceuticals for pancreatic cancer, the drug maker said Monday.

CAMBRIDGE, Mass. — The Food and Drug Administration has granted orphan drug designation to a chemotherapy drug made by Merrimack Pharmaceuticals for pancreatic cancer, the drug maker said Monday.

Merrimack announced that it received the designation for MM-398, described as a novel, stable, nanotherapeutic encapsulation of the chemotherapy drug irinotecan.

August 1, 2011

In a report issued last week, the National Association of Boards of Pharmacy found that 96% of rogue websites analyzed continue to operate out of compliance with U.S. pharmacy laws, fuel prescription drug abuse and misuse, and provide an outlet for counterfeit medicines to enter the U.S. drug supply.

MOUNT PROSPECT, Ill. — In a report issued last week, the National Association of Boards of Pharmacy found that 96% of rogue websites analyzed continue to operate out of compliance with U.S. pharmacy laws, fuel prescription drug abuse and misuse, and provide an outlet for counterfeit medicines to enter the U.S. drug supply.

Among 8,000 websites analyzed in "Internet Drug Outlet Identification Program Progress Report for State and Federal Regulators: July 2011," NABP discovered that:

July 29, 2011

Teva Pharmaceuticals has launched an authorized generic version of a contraceptive made by Duramed Pharmaceuticals, Teva said.

JERUSALEM — Teva Pharmaceuticals has launched an authorized generic version of a contraceptive made by Duramed Pharmaceuticals, Teva said.

Teva announced the launch of Camrese, an authorized generic of Duramed’s Seasonique (levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets).

The launch of Teva’s authorized generic follows the launch of Watson Pharmaceuticals’ generic version of the drug, which it is marketing under the name Amethia.

July 28, 2011

Drug makers Eli Lilly, Amylin Pharmaceuticals and Alkermes are giving their long-acting form of an injected drug for Type 2 diabetes another try at the Food and Drug Administration.

INDIANAPOLIS — Drug makers Eli Lilly, Amylin Pharmaceuticals and Alkermes are giving their long-acting form of an injected drug for Type 2 diabetes another try at the Food and Drug Administration.

July 28, 2011

The National Association of Chain Drug Stores announced on Thursday that it submitted comments to the U.S. Senate Health, Education, Labor and Pensions Committee, which held a hearing Thursday titled "FDA User Fees: Advancing Public Health," outlining community pharmacy's commitment to addressing drug safety and the appropriate use of prescription medications to help improve patient health.

ALEXANDRIA, Va. — The National Association of Chain Drug Stores announced on Thursday that it submitted comments to the U.S. Senate Health, Education, Labor and Pensions Committee, which held a hearing Thursday titled "FDA User Fees: Advancing Public Health," outlining community pharmacy's commitment to addressing drug safety and the appropriate use of prescription medications to help improve patient health.

July 27, 2011

Eli Lilly has launched its physician payment registry, a website that enables visitors to search payments to individual U.S.-based physicians and the institutions or research organizations that receive payments on behalf of a physician.

INDIANAPOLIS — Eli Lilly has launched its physician payment registry, a website that enables visitors to search payments to individual U.S.-based physicians and the institutions or research organizations that receive payments on behalf of a physician.

The drug maker said that its website, which is in line with its corporate integrity agreement with the U.S. government, aims to show how the company works with U.S. physicians and compensates them for their services and how these collaborations benefit patient care.

July 25, 2011

Health care is like precision engineering; tweaking one element ever so slightly can mean the difference between a healthy life and an early death or, in the case of drug spending, between nearly $50,000 and just north of $1,000.


Health care is like precision engineering; tweaking one element ever so slightly can mean the difference between a healthy life and an early death or, in the case of drug spending, between nearly $50,000 and just north of $1,000.


July 25, 2011


The Food and Drug Administration last month published long-awaited draft guidance on new dietary ingredients in the Federal Register.


The Food and Drug Administration last month published long-awaited draft guidance on new dietary ingredients in the Federal Register. Once finalized, the guidance will establish an additional pillar of credibility to the dietary supplement industry and help counter criticism that the FDA does not regulate the safety of supplement products — that is, if the FDA doesn’t force supplements off the shelf that are already on the shelf today. 


July 25, 2011

The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating deep vein thrombosis in patients undergoing knee or hip replacement surgery, a J&J subsidiary said.

SUPPLIER NEWS — The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating deep vein thrombosis in patients undergoing knee or hip replacement surgery, a J&J subsidiary said. Janssen Pharmaceuticals announced the approval of Xarelto (rivaroxaban) tablets as a once-daily oral anticoagulant for DVT, a condition that could lead to pulmonary embolism.


July 22, 2011

The National Association of Chain Drug Stores announced Thursday that it has submitted comments to the U.S. Senate Special Committee on Aging outlining the value of the pharmacist-patient interaction in helping improve health and reduce costs in the Medicare program, and urged the committee to support the Medication Therapy Management Empowerment Act of 2011, which seeks to increase access to pharmacy services for Medicare beneficiaries.

ALEXANDRIA, Va. — The National Association of Chain Drug Stores announced Thursday that it has submitted comments to the U.S. Senate Special Committee on Aging outlining the value of the pharmacist-patient interaction in helping improve health and reduce costs in the Medicare program, and urged the committee to support the Medication Therapy Management Empowerment Act of 2011, which seeks to increase access to pharmacy services for Medicare beneficiaries.

July 22, 2011

Bipartisan legislation recently introduced to the Senate has received endorsement from a group representing the retail pharmacy industry.

ALEXANDRIA, Va. — Bipartisan legislation recently introduced to the Senate has received endorsement from a group representing the retail pharmacy industry.

July 21, 2011

The Food and Drug Administration has approved a drug made by AstraZeneca to reduce the rate of heart attacks in patients with acute coronary syndrome, the Anglo-Swedish drug maker said.

WILMINGTON, Del. — The Food and Drug Administration has approved a drug made by AstraZeneca to reduce the rate of heart attacks in patients with acute coronary syndrome, the Anglo-Swedish drug maker said.

AstraZeneca announced the approval of Brilinta (ticagrelor), a blood-thinning drug, on Wednesday. The drug maker is touting the drug as an alternative to Plavix (clopidogrel), made by Sanofi and Bristol-Myers Squibb.

July 19, 2011

New bipartisan legislation introduced to the Senate last week seeks to offer states incentives to use generic drugs by allowing states to temporarily keep a portion of the savings.

WASHINGTON — New bipartisan legislation introduced to the Senate last week seeks to offer states incentives to use generic drugs by allowing states to temporarily keep a portion of the savings.

Senators Scott Brown, R-Mass.; Ron Wyden, D-Ore.; and John McCain, R-Ariz., introduced the Affordable Medicines Utilization Act of 2011, saying that the bill would encourage states to take advantage of cost-saving generic drugs.

July 19, 2011

Generic drug maker Teva recently admitted that one of its drugs infringes two of Amgen's patents.

THOUSAND OAKS, Calif. — Generic drug maker Teva recently admitted that one of its drugs infringes two of Amgen's patents.

The U.S. District Court in Pennsylvania has barred Teva from selling its human G-CSF (human granulocyte colony-stimulating factor) product Neutroval in the United States until Nov. 10, 2013. What's more, the court's injunction extends to Teva's other human G-CSF product, Neugranin. Teva will not sell Neugranin until Nov. 10, 2013, unless it first obtains a final court decision that Amgen's patents are not infringed by Neugranin.

July 14, 2011

Watson Pharmaceuticals last week confirmed that the United States Court of Appeals for the Federal Circuit has affirmed the United States District Court for the Southern District of Florida's February 2011 decision that Watson's generic versions of Mucinex, Mucinex D and Mucinex DM extended-release products do not infringe Reckitt Benckiser’s U.S. Patent No. 6,372,252.

PARSIPPANY, N.J. — Watson Pharmaceuticals last week confirmed that the United States Court of Appeals for the Federal Circuit has affirmed the United States District Court for the Southern District of Florida's February 2011 decision that Watson's generic versions of Mucinex, Mucinex D and Mucinex DM extended-release products do not infringe Reckitt Benckiser’s U.S. Patent No. 6,372,252. 

Watson stated it is continuing to seek final approval of the products from the Food and Drug Administration.