Content about Pharmaceuticals policy

July 10, 2012

Generic drug maker Mylan is suing Warner Chilcott and an Australian company, alleging that they illegally tried to protect one of their drugs from generic competition, according to published reports.

NEW YORK — Generic drug maker Mylan is suing Warner Chilcott and an Australian company, alleging that they illegally tried to protect one of their drugs from generic competition, according to published reports.

Reuters reported that Mylan filed a suit against Warner Chilcott and Mayne Pharma Group over the antibiotic and acne drug Doryx (doxycycline), saying they made minor and insignificant changes to the drug so that approval of generic versions would be delayed.

July 5, 2012

Actavis has received a preliminary approval for a generic drug for treating high blood pressure, the drug maker said Thursday.

MORRISTOWN, N.J. — Actavis has received a preliminary approval for a generic drug for treating high blood pressure, the drug maker said Thursday.

June 28, 2012

A drug maker and a branch of the National Education Association have released a set of education resources designed to curb prescription drug abuse and misuse.

WASHINGTON — A drug maker and a branch of the National Education Association have released a set of education resources designed to curb prescription drug abuse and misuse.

The NEA Health Information Network and Purdue Pharma announced Thursday the release of "Rx for Understanding," which includes 10 cross-curricular lessons for middle school students. The lessons are aligned with the National Health Education Standards and the Common Core State Standards.

June 27, 2012

The Food and Drug Administration has approved an acne treatment made by Perrigo, the drug maker said Wednesday.

ALLEGAN, Mich. — The Food and Drug Administration has approved an acne treatment made by Perrigo, the drug maker said Wednesday.

June 26, 2012

Generic drug maker Watson Pharmaceuticals is challenging the patent protection on an antidepressant made by Pfizer, the company said.

PARSIPPANY, N.J. — Generic drug maker Watson Pharmaceuticals is challenging the patent protection on an antidepressant made by Pfizer, the company said.

Watson filed a regulatory approval application with the Food and Drug Administration for desvenlafaxine succinate extended-release tablets in the 50-mg and 100-mg strengths. The drug is a generic version of Pfizer's Pristiq.

June 22, 2012

A drug maker has resubmitted its new drug application to the Food and Drug Administration for an acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.

MOUNTAIN VIEW, Calif. — A drug maker has resubmitted its new drug application to the Food and Drug Administration for an acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.

Alexza Pharmaceuticals said it received a complete response letter for Adasuve last month from the regulatory agency. The CRL outlined the FDA's concerns about Alexza's manufacturing facility and the drug's draft product labeling. Alexza said it believes it has addressed these concerns in its resubmitted application.

June 21, 2012

The leader of the country’s largest privately owned specialty pharmacy provider had a day in Washington.

FLINT, Mich. — The leader of the country’s largest privately owned specialty pharmacy provider had a day in Washington. Diplomat Specialty Pharmacy CEO Phil Hagerman and several other business leaders were invited last month to attend a one-day forum on jobs and the economy, and opportunities for collaboration between government and private sector, by the White House Business Council and Business Forward.

June 21, 2012

Faced with the possibility of a critical cutoff in funding for the Food and Drug Administration, Congress moved in late May to reauthorize the Prescription Drug User Fee Act that provides the bulk of the agency’s resources for new-drug review and approval. 


Faced with the possibility of a critical cutoff in funding for the Food and Drug Administration, Congress moved in late May to reauthorize the Prescription Drug User Fee Act that provides the bulk of the agency’s resources for new-drug review and approval. 


June 20, 2012

The National Association of Chain Drug Stores on Wednesday urged Congress to pass the Prescription Drug User Fee Act, legislation essential to the review process for new medications and that also contains important pro-patient, pro-pharmacy provisions.

ALEXANDRIA, Va. — The National Association of Chain Drug Stores on Wednesday urged Congress to pass the Prescription Drug User Fee Act, legislation essential to the review process for new medications and that also contains important pro-patient, pro-pharmacy provisions.

The U.S. House and Senate passed their versions of PDUFA last month and worked to reconcile their individual bills into one final bill. Both chambers are expected to vote on the final conference report this week.

June 15, 2012

Upsher-Smith wins 2012 DIANAs in Branded Pharmaceutical Product Manufacturer and Consumer Product Manufacturer categories.

MAPLE GROVE, Minn. — Upsher-Smith Labs has been named a 2012 winner of the Healthcare Distribution Management Association DIANA Awards. The Distribution Industry Awards for Notable Achievements in Healthcare, known more familiarly as the DIANAs, are awarded each year by HDMA to leading pharmaceutical and consumer product manufacturers.

June 14, 2012

In healthcare technology circles, e-prescribing is among today’s hottest topics. A vital component of patient-centered care, it creates a connectivity platform that encourages collaboration between the physician and pharmacist who are in joint pursuit of an enhanced patient experience.

In healthcare technology circles, e-prescribing is among today’s hottest topics. A vital component of patient-centered care, it creates a connectivity platform that encourages collaboration between the physician and pharmacist who are in joint pursuit of an enhanced patient experience.

June 13, 2012

As the U.S. Senate and House reconcile their versions of the Prescription Drug User Fee Act, the National Association of Chain Drug Stores on Wednesday urged U.S. House and Senate leaders to expand provisions in the final bill to help ensure that Americans continue to have access to safe and effective prescription medications, while also curbing prescription drug abuse.

ALEXANDRIA, Va. — As the U.S. Senate and House reconcile their versions of the Prescription Drug User Fee Act, the National Association of Chain Drug Stores on Wednesday urged U.S. House and Senate leaders to expand provisions in the final bill to help ensure that Americans continue to have access to safe and effective prescription medications, while also curbing prescription drug abuse.

June 11, 2012

With overwhelming support in both the U.S. House and Senate and the strong backing of President Obama, a reauthorization of the landmark Prescription Drug User Fee Act that funds new drug application reviews at the Food and Drug Administration is a near certainty, probably within days or weeks at most. But one amendment to the Senate's version of PDUFA reauthorization, contained in the Food and Drug Administration Safety Innovation Act, could threaten both retail pharmacies and the patients they serve.

With overwhelming support in both the U.S. House and Senate and the strong backing of President Obama, a reauthorization of the landmark Prescription Drug User Fee Act that funds new drug application reviews at the Food and Drug Administration is a near certainty, probably within days or weeks at most. But one amendment to the Senate's version of PDUFA reauthorization, contained in the Food and Drug Administration Safety Innovation Act, could threaten both retail pharmacies and the patients they serve.

June 11, 2012

The state of New York is looking to become a national leader in curbing prescription drug abuse.

ALBANY, N.Y. — The state of New York is looking to become a national leader in curbing prescription drug abuse.

June 7, 2012

Government authorities are working to educate independent pharmacy owners on prescription drug abuse, an independent pharmacy network said.

SCOTTSBORO, Ala. — Government authorities are working to educate independent pharmacy owners on prescription drug abuse, an independent pharmacy network said.

In an event sponsored by American Associated Pharmacies in San Diego, Drug Enforcement Administration deputy assistant administrator for the Office of Diversion Control Joseph Rannazzisi discussed topics related to prescription drug abuse. Rannazzisi explained how drug abusers divert prescription drugs through doctor shopping, forged prescriptions, theft and the Internet.

June 6, 2012

A generic drug maker in India and a German pharmaceutical company will collaborate to develop biosimilars.

HYDERABAD, India — A generic drug maker in India and a German pharmaceutical company will collaborate to develop biosimilars.

Dr. Reddy's Labs and Merck KGaA subsidiary Merck Serono announced a partnership to develop biosimilar cancer treatments, most of them monoclonal antibodies, for global markets. Based in Darmstadt, Germany, Merck KGaA operates in the United States under the name EMD to distinguish itself from U.S. drug maker Merck.

June 4, 2012

Drug maker Takeda Pharmaceutical has finished its purchase of URL Pharma, the companies said Monday.

DEERFIELD, Ill. — Drug maker Takeda Pharmaceutical has finished its purchase of URL Pharma, the companies said Monday.

Japan-based Takeda announced in April that it would buy URL for $800 million. The acquisition, through local subsidiary Takeda Pharmaceuticals USA, gives Takeda control of the gout drug Colcrys (colchicine). URL will report to Takeda Pharmaceuticals USA president Douglas Cole, and the acquisition is expected to boost 2012 sales by $550 million, Takeda said.

May 31, 2012

The House Ways and Means Committee on Thursday approved the Restoring Access to Medication Act (H.R. 5842), which would repeal the provision of the Patient Protection and Affordable Care Act that disqualified expenses for over-the-counter drugs as eligible for reimbursement under health savings accounts and flexible spending arrangements without a prescription.

WASHINGTON — The House Ways and Means Committee on Thursday approved the Restoring Access to Medication Act (H.R. 5842), which would repeal the provision of the Patient Protection and Affordable Care Act that disqualified expenses for over-the-counter drugs as eligible for reimbursement under health savings accounts and flexible spending arrangements without a prescription.

May 31, 2012

The House of Representatives on Wednesday passed legislation that reauthorizes the Food and Drug Administration’s prescription drug user fee programs that are scheduled to expire in September. H.R. 5651 passed the House by a vote of 387 to 5.

WASHINGTON — The House of Representatives on Wednesday passed legislation that reauthorizes the Food and Drug Administration’s prescription drug user fee programs that are scheduled to expire in September. H.R. 5651 passed the House by a vote of 387 to 5.

The bill, a version of which already passed through the Senate, now heads to committee where the House and Senate versions of the bill can be reconciled before Oct. 1 and submitted to the president. According to published reports, the Senate version would require more scrutiny for some new devices.

May 30, 2012

The House of Representatives will be debating H.R. 5651 Wednesday afternoon — a bill that, if passed, will reauthorize the Prescription Drug User Fee Act.

WASHINGTON — The House of Representatives will be debating H.R. 5651 Wednesday afternoon — a bill that, if passed, will reauthorize the Prescription Drug User Fee Act. 

The Senate passed a similar measure last week by a vote of 96-to-1 with three senators not voting.

May 30, 2012

Some health insurers are requiring patients to pay larger sums for specialty drugs, according to published reports.

NEW YORK — Some health insurers are requiring patients to pay larger sums for specialty drugs, according to published reports.

May 30, 2012

Two supermarket chains owned by Royal Ahold are dispensing prescription pet drugs at their stores, they said Wednesday.

QUINCY, Mass. — Two supermarket chains owned by Royal Ahold are dispensing prescription pet drugs at their stores, they said Wednesday.

May 29, 2012

The House of Representatives will vote to repeal limitations on the use of tax-advantaged accounts for the purchase of over-the-counter medications as early as June 4, according to a report published online by The Hill, a Washington, D.C.-based political newspaper.

WASHINGTON — The House of Representatives will vote to repeal limitations on the use of tax-advantaged accounts for the purchase of over-the-counter medications as early as June 4, according to a report published online by The Hill, a Washington, D.C.-based political newspaper.

The paper cited a planning memo from majority leader Eric Cantor, R-Va.

May 29, 2012

Generic drug maker Sun Pharmaceutical Industries appointed a new chairman as the company announced big jumps in fourth-quarter and fiscal year 2012 sales and profits.

MUMBAI, India — Generic drug maker Sun Pharmaceutical Industries appointed a new chairman as the company announced big jumps in fourth-quarter and fiscal year 2012 sales and profits.

The drug maker announced the appointment of former Teva Pharmaceutical Industries president and CEO Israel Makov as chairman. Makov, who began working for Teva in 1995, and led it as president and CEO from 2002 to 2007, is widely credited with that company becoming the world's largest generic drug maker and one of the world's largest drug makers overall.

May 29, 2012

Generic drug maker Watson Pharmaceuticals has entered a settlement that will allow it to launch a generic patch used to treat post herpetic neuralgia, a pain disorder associated with shingles.

PARSIPPANY, N.J. — Generic drug maker Watson Pharmaceuticals has entered a settlement that will allow it to launch a generic patch used to treat post herpetic neuralgia, a pain disorder associated with shingles.

Watson announced Tuesday a settlement through one of its subsidiaries with Endo Pharmaceuticals and Teikoku Seiyaku Co. over its generic version of Lidoderm (lidocaine) topical patch. Lidoderm had sales of $1.2 billion during the 12-month period ended in March 2012, according to IMS Health.