Content about Pharmaceutical industry

April 21, 2013

Last month, the Supreme Court heard Federal Trade Commission v. Actavis, which could impact the future of the generic drug industry at a time when 80% of all prescriptions dispensed in the United States are generic.

Last month, the Supreme Court heard Federal Trade Commission v. Actavis, which could impact the future of the generic drug industry at a time when 80% of all prescriptions dispensed in the United States are generic.

April 19, 2013

The Food and Drug Administration has given tentative approval to two generic diabetes drugs made by Sun Pharmaceutical Industries, the Indian drug maker said.

MUMBAI, India — The Food and Drug Administration has given tentative approval to two generic diabetes drugs made by Sun Pharmaceutical Industries, the Indian drug maker said.

Sun announced the tentative approvals for sitagliptin tablets in the 25 mg, 50 mg and 100 mg strengths and metformin hydrochloride extended-release tablets in the 500 mg and 1,000 mg strengths. The drugs are respectively generic versions of Merck's Januvia and Santarus' Glumetza.

April 19, 2013

President Barack Obama sent his $3.8 trillion budget proposal to Congress on April 10, and the plan includes a number of provisions designed to cut spending on health care and promote health and wellness.

Overall, the budget is something of a mixed bag for the healthcare industry. While it would provide incentives for expanding the use of generic drugs, for example, it would also cut spending on Medicaid that have drawn opposition from pharmacy retailers, and even generic drug makers disagree with some of its provisions for that industry.

President Barack Obama sent his $3.8 trillion budget proposal to Congress on April 10, and the plan includes a number of provisions designed to cut spending on health care and promote health and wellness.

Overall, the budget is something of a mixed bag for the healthcare industry. While it would provide incentives for expanding the use of generic drugs, for example, it would also cut spending on Medicaid that have drawn opposition from pharmacy retailers, and even generic drug makers disagree with some of its provisions for that industry.

April 17, 2013

Generic drug maker Sandoz has launched a generic version of a drug used to treat high blood pressure and angina.

PRINCETON, N.J. — Generic drug maker Sandoz has launched a generic version of a drug used to treat high blood pressure and angina.

The company, a subsidiary of Swiss drug maker Novartis, announced the launch of diltiazem hydrochloride extended-release capsules, a generic version of Forest Labs' Tiazac. Sandoz is launching the drug in the 120-mg, 180-mg, 240-mg, 300-mg, 360-mg and 420-mg strengths.

Various versions of the drug had sales of about $174 million in 2012, according to IMS Health.

 

April 16, 2013

The Food and Drug Administration will not approve generic versions of Purdue Pharma's painkiller OxyContin based on earlier versions of the drug that did not include features to thwart abuse, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration will not approve generic versions of Purdue Pharma's painkiller OxyContin based on earlier versions of the drug that did not include features to thwart abuse, the agency said Tuesday.

The FDA announced that it approved updated labeling for reformulated OxyContin (oxycodone) extended-release tablets indicating that it has physical and chemical properties designed to deter drug abusers from crushing or dissolving the pills in order to inject or snort them.

April 16, 2013

Taro Pharmaceutical Industries reported last week that it has received approval from the Food and Drug Administration for its new drug application Topicort (desoximetasone) topical spray, 0.25%.

HAWTHORNE, N.Y. — Taro Pharmaceutical Industries reported last week that it has received approval from the Food and Drug Administration for its new drug application Topicort (desoximetasone) topical spray, 0.25%.

Topicort topical spray, 0.25% is a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older.

According to Taro, the corticosteroid spray market is approximately $100 million in annual sales in the United States.

April 15, 2013

Generic makers heralded the fiscal year 2014 budget proposed last week by the Obama administration for its embrace of generic drugs, but were critical of its provisions on patent settlements and rebates.

WASHINGTON — Generic makers heralded the fiscal year 2014 budget proposed last week by the Obama administration for its embrace of generic drugs, but were critical of its provisions on patent settlements and rebates.

April 12, 2013

The Food and Drug Administration is granting an expedited application process to a company that has developed a treatment for a condition related to Parkinson's disease, meaning that it can cancel a planned late-stage clinical trial, the company said.

SAN DIEGO — The Food and Drug Administration is granting an expedited application process to a company that has developed a treatment for a condition related to Parkinson's disease, meaning that it can cancel a planned late-stage clinical trial, the company said.

April 12, 2013

Celgene Corp. chairman and CEO Robert Hugin has been elected as chairman of a pharmaceutical industry trade group.

SAN DIEGO — Celgene Corp. chairman and CEO Robert Hugin has been elected as chairman of a pharmaceutical industry trade group.

The Pharmaceutical Research and Manufacturers of America announced the election of Hugin, as well as Pfizer president and CEO Ian Read as chairman-elect of the PhRMA board of directors and Merck chairman, president and CEO as board treasurer.

Hugin succeeds Eli Lilly president, chairman and CEO John Lechleiter as chairman, PhRMA said.

 

April 12, 2013

Drug companies' pharmaceutical portfolio management teams spend most of their time and budgets supporting niche products, according to a new study.

RESEARCH TRIANGLE PARK, N.C. — Drug companies' pharmaceutical portfolio management teams spend most of their time and budgets supporting niche products, according to a new study.

April 12, 2013

The Food and Drug Administration has approved a contraceptive therapy made by Lupin Pharmaceuticals, the Indian drug maker said Friday.

MUMBAI, India — The Food and Drug Administration has approved a contraceptive therapy made by Lupin Pharmaceuticals, the Indian drug maker said Friday.

Lupin announced the approval of Daysee (levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets) in the 0.15-mg/0.03-mg and 0.01-mg strengths.

The drug is a generic version of Teva's Seasonique. Various versions of the drug had sales of $161 million in 2012, according to IMS Health.

 

April 8, 2013

Teva Pharmaceutical Industries has launched a generic opioid medication for treating pain, the company said.

NORTH WALES, Pa. — Teva Pharmaceutical Industries has launched a generic opioid medication for treating pain, the company said.

Teva announced the introduction of oxymorphone hydrochloride tablets.

The drug is a generic version of Endo Pharmaceuticals' Opana and will be available in the 5 mg and 10 mg strengths in bottles of 100 tablets.

 

April 5, 2013

Actavis will market and distribute an authorized generic version of a genital herpes ointment made by Valeant Pharmaceuticals International, the companies said Friday.

PARSIPPANY, N.J. — Actavis will market and distribute an authorized generic version of a genital herpes ointment made by Valeant Pharmaceuticals International, the companies said Friday.

The agreement centers around Zovirax, known generically as acyclovir, in the 5% strength. The Food and Drug Administration approved the generic version, made by Mylan, on Wednesday. Financial terms of the deal were not disclosed.

April 4, 2013

Swiss drug maker Covis Pharma will buy U.S. rights to five drugs from Sanofi, Covis said.

ZUG, Switzerland — Swiss drug maker Covis Pharma will buy U.S. rights to five drugs from Sanofi, Covis said Thursday.

April 4, 2013

The Food and Drug Administration has given preliminary approval to a drug made by Aurobindo Pharma for treating HIV infection, the drug maker said.

HYDERABAD, India — The Food and Drug Administration has given preliminary approval to a drug made by Aurobindo Pharma for treating HIV infection in developing countries, the drug maker said.

Aurobindo announced that it had received tentative approval for efavirenz/emtricitabine/tenofovir disoproxil fumarate combination tablets in the 600-mg/200 mg/300-mg strength. The drug is a generic version of Gilead Sciences' Atripla.

April 4, 2013

Novartis is promoting the multiple sclerosis drug Gilenya to young people with a new ad campaign in several national magazine's and websites, according to published reports.

NEW YORK — Novartis is promoting the multiple sclerosis drug Gilenya to young people with a new ad campaign in several national magazine's and websites, according to published reports.

The New York Times reported that the Swiss drug maker had placed ads for its "Hey MS, Take This!" campaign in People, Shape and Self, as well as the website of women's magazines, in addition to online videos. The generic name of Gilenya is fingolimod.

April 2, 2013

A court has ruled in favor of generic drug maker Actavis concerning its generic version of a drug to treat asthma in children, the company said.

PARSIPPANY, N.J. — A court has ruled in favor of generic drug maker Actavis concerning its generic version of a drug to treat asthma in children, the company said.

April 2, 2013

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.

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.

April 1, 2013

The Food and Drug Administration has approved a new contraceptive therapy made by Teva Pharmaceutical Industries, Teva said Monday.

JERUSALEM — The Food and Drug Administration has approved a new contraceptive therapy made by Teva Pharmaceutical Industries, Teva said Monday.

The drug maker announced the approval of Quartette (levonorgestrel, ethinyl estradiol and ethinyl estradiol) tablets. Teva said the drug represented the "next generation" of extended-regimen oral contraceptives and was designed to minimize breakthrough bleeding between scheduled periods.

March 28, 2013

The generic drug industry's main trade group in Washington has hired a prominent lobbyist to head its government affairs team.

WASHINGTON — The generic drug industry's main trade group in Washington has hired a prominent lobbyist to head its government affairs team.

The Generic Pharmaceutical Association announced that it had hired Melissa Schulman as SVP government affairs, describing her as "one of the best known advocates" in Washington, noting her ranking as an influential lobbyist in publications such as Roll Call, The Hill and National Journal. Schulman previously worked as a Democratic lobbyist for the Bockorny Group.

March 26, 2013

The Food and Drug Administration has declined to approve a bird flu vaccine made by GlaxoSmithKline due to an administrative issue, the drug maker said.

LONDON — The Food and Drug Administration has declined to approve a bird flu vaccine made by GlaxoSmithKline due to an administrative issue, the drug maker said.

GSK said it received a complete response letter from the FDA for its vaccine for pandemic influenza A virus monovalent adjuvanted candidate vaccine, also known as Q-Pan H5N1. The FDA issues a complete response letter when it needs additional time to review a drug application for approval.

March 25, 2013

Generic drug maker Actavis has reached a deal with AstraZeneca that will allow it to launch a version of a drug used to treat cholesterol in three years, Actavis said Monday.

PARSIPPANY, N.J. — Generic drug maker Actavis has reached a deal with AstraZeneca that will allow it to launch a version of a drug used to treat cholesterol in three years, Actavis said Monday.

Under a deal to settle a patent-infringement lawsuit, Actavis will be allowed to launch its generic version of Crestor (rosuvastatin calcium) tablets in the 5-mg, 10-mg, 20-mg and 40-mg strengths 67 days before July 8, 2016, when the drug's market exclusivity for use in children expires, at a fee of 39% of net sales to AstraZeneca.

March 25, 2013

More than 400 drugs are under development for the 10 most common chronic health conditions affecting elderly people, according to a new report by a drug industry trade group.

WASHINGTON — More than 400 drugs are under development for the 10 most common chronic health conditions affecting elderly people, according to a new report by a drug industry trade group.

March 25, 2013

Boehringer Ingelheim and Eli Lilly are seeking regulatory approval for an experimental drug to treat Type 2 diabetes, the companies said.

RIDGEFIELD, Conn. — Boehringer Ingelheim and Eli Lilly are seeking regulatory approval for an experimental drug to treat Type 2 diabetes, the companies said Monday.

BI and Lilly announced the submission of a regulatory application to the Food and Drug Administration for empagliflozin. The drug belongs to a new drug class known as SGLT2 inhibitors, which work by removing excess glucose through the urine by blocking its reabsorption in the kidneys. The companies are testing the drug in a late-stage clinical trial for which they plan to enroll 14,500 patients.

March 25, 2013

The Supreme Court heard arguments Monday in a case that could determine the future of generic drugs in America.

NEW YORK — The Supreme Court heard arguments Monday in a case that could determine the future of generic drugs in America.

The case, Federal Trade Commission v. Actavis, marks the latest attempt by federal authorities to put an end to what they say are deals between branded and generic drug companies that delay release of generic drugs to consumers.