Content about Organic chemistry

May 22, 2013

The Food and Drug Administration has approved a generic heart disease drug made by Sandoz, the company said.

PRINCETON, N.J. — The Food and Drug Administration has approved a generic heart-disease drug made by Sandoz, the company said Wednesday.

Sandoz, the generics division of Swiss drug maker Novartis, announced the approval of candesartan cilexetil tablets, a generic version of AstraZeneca's Atacand.

The drug is used to treat some types of heart failure in adults with left ventricular systolic dysfunction, as well as high blood pressure in adults and children as young as 1.

Atacand had sales of $120.3 million in 2012, according to IMS Health.

May 17, 2013

A Food and Drug Administration panel will consider whether to recommend approval for an experimental painkiller in July, the drug's developer said Friday.

SYDNEY — A Food and Drug Administration panel will consider whether to recommend approval for an experimental painkiller in July, the drug's developer said Friday.

Australia-based QRxPharma said the FDA had determined that an advisory committee would meet on July 17 to consider a resubmitted application for Moxduo, an immediate-release formulation of the opioid painkillers morphine and oxycodone.

May 17, 2013

Mylan has launched a generic drug for treating cholesterol, the company said.

PITTSBURGH — Mylan has launched a generic drug for treating cholesterol, the company said Friday.

Mylan announced the launch of fenofibrate tablets in the 48 mg and 145 mg strengths. The drug is used to reduce so-called "bad" low-density lipoprotein cholesterol, total cholesterol, triglycerides and apolipoprotein B while increasing "good" high-density lipoprotein cholesterol in adults with primary hyperocholesterolemia or mixed dyslipidemia.

May 15, 2013

The Food and Drug Administration has approved a drug for a type of lung cancer.

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.

 

May 13, 2013

A ruling by the Food and Drug Administration means that generic versions of an opioid painkiller made by Endo Pharmaceuticals can stay on the market, drawing criticism from the drug maker.

SILVER SPRING, Md. — A ruling by the Food and Drug Administration means that generic versions of an opioid painkiller made by Endo Pharmaceuticals can stay on the market, drawing criticism from the drug maker.

May 8, 2013

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.

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. 

May 6, 2013

Pfizer is attempting to stem the rise of counterfeit medicines by selling one of its most popular drugs — and one of the most popular targets for counterfeiters — online.

NEW YORK — Pfizer is attempting to stem the rise of counterfeit medicines by selling one of its most popular drugs — and one of the most popular targets for counterfeiters — online.

The drug maker announced that it had launched Viagra (sildenafil citrate) home delivery, a prescription-fulfillment website for the drug, which is powered by CVS/pharmacy and accessible through Viagra.com.

May 6, 2013

The Food and Drug Administration has approved a drug for HIV in infants and toddlers.

PRINCETON, N.J. — The Food and Drug Administration has approved a drug for HIV in infants and toddlers.

May 6, 2013

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

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.

April 30, 2013

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

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.

April 30, 2013

The Food and Drug Administration declined to approve two drugs for HIV made by Gilead Sciences for which the company was seeking approval for use as part of treatment regimens.

FOSTER CITY, Calif. — The Food and Drug Administration declined to approve two drugs for HIV made by Gilead Sciences for which the company was seeking approval for use as part of treatment regimens.

April 26, 2013

Generic drug maker Actavis is settling a patent-infringement suit with Purdue Pharma concerning the opioid painkiller OxyContin, Actavis said, saying it expected to make more than $100 million in the deal between 2014 and 2015.

PARSIPPANY, N.J. — Generic drug maker Actavis is settling a patent-infringement suit with Purdue Pharma concerning the opioid painkiller OxyContin, Actavis said Friday, saying it expected to make more than $100 million in the deal between 2014 and 2015.

April 24, 2013

The Food and Drug Administration has approved a new drug for constipation related to use of opioid painkillers made by Sucampo Pharmaceuticals and Takeda Pharmaceuticals, the drug makers said.

BETHESDA, Md. — The Food and Drug Administration has approved a new drug for constipation related to use of opioid painkillers made by Sucampo Pharmaceuticals and Takeda Pharmaceuticals, the drug makers said.

April 22, 2013

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

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

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 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

Purdue Pharma's patent for OxyContin expired Tuesday, opening up the opioid painkiller to generic competition, but authorities have raised concerns about what they call the potential for generic versions to be abused.

NEW YORK — Purdue Pharma's patent for OxyContin expired Tuesday, opening up the opioid painkiller to generic competition, but authorities have raised concerns about what they call the potential for generic versions to be abused.

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 10, 2013

Patients who use retail-based health clinics are satisfied with their visit, according to the findings of a new Kalorama Information report.

NEW YORK — Patients who use retail-based health clinics are satisfied with their visit, according to the findings of a new Kalorama Information report.

The healthcare market research publisher, which is a division of MarketResearch.com, has been covering retail clinics for six years and conducted a survey of U.S. adults to determine retail clinic use and satisfaction. According to the Retail Clinics: Consumer Attitudes Results of the 2013 Kalorama Survey, 91% of those surveyed who had used a retail clinic were either satisfied or very satisfied.

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 4, 2013

The March/April 2013 Allergy Relief Ingredient Guide breaks down the indication, ingredients, purpose and dosage of Claritin-D, Allegra-D, Zyrtec-D, Benadryl-D, Advil Allergy and Congestion Relief, UrgentRx Allergy Attack, Hyland's Seasonal Allergy Relief, Similasan's Nasal Allergy Relief and Boiron's Sabadil.

The March/April 2013 Allergy Relief Ingredient Guide breaks down the indication, ingredients, purpose and dosage of Claritin-D, Allegra-D, Zyrtec-D, Benadryl-D, Advil Allergy and Congestion Relief, UrgentRx Allergy Attack, Hyland's Seasonal Allergy Relief, Similasan's Nasal Allergy Relief and Boiron's Sabadil.

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 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.

March 27, 2013

The Food and Drug Administration has approved a treatment made by Eisai for gastroesophageal reflux disease in children ages 1 year to 11 years, the drug maker said.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a treatment made by Eisai for gastroesophageal reflux disease in children ages 1 year to 11 years, the drug maker said.

Eisai announced the approval of Aciphex Sprinkle (rabeprazole sodium) delayed-release capsules.