Content about Organofluorides

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 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 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 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 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.

March 14, 2013

The Food and Drug Administration has approved a drug for obsessive compulsive disorder made by Par Pharmaceutical Cos., the drug maker said Thursday.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a drug for obsessive compulsive disorder made by Par Pharmaceutical Cos., the drug maker said Thursday.

Par announced the approval and shipment of fluvoxamine maleate extended-release capsules in the 100-mg and 150-mg strengths. The drug is a generic version of Jazz Pharmaceuticals' Luvox CR.

March 14, 2013

Wegmans will be offering the popular cholesterol-lowering drug atorvastatin free of charge through the end of the year, according to a report published by the Philadelphia Inquirer.

PHILADELPHIA — Wegmans will be offering the popular cholesterol-lowering drug atorvastatin free of charge through the end of the year, according to a report published by the Philadelphia Inquirer Wednesday. 

February 26, 2013

Greenstone has launched an authorized generic version of a drug used to treat cholesterol.

PEAPACK, N.J. — Greenstone has launched an authorized generic version of a drug used to treat cholesterol.

Greenstone, the generics arm of Pfizer, announced the launch of authorized generic atorvastatin calcium tablets in the 10 mg, 20 mg, 40 mg and 80 mg strengths, in bottle sizes ranging from 90 to 1,000. The drug is a version of the parent company's cholesterol drug Lipitor.

An authorized generic is a brand marketed under its generic name at a reduced price.

February 25, 2013

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.

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).

February 4, 2013

Drug maker Perrigo has launched a generic drug for treating problems of the scalp, the company said.

ALLEGAN, Mich. — Drug maker Perrigo has launched a generic drug for treating problems of the scalp, the company said.

Perrigo announced the launch of clobetasol emulsion propionate foam in the 0.05% strength, a generic version of GlaxoSmithKline's Olux-E. The drug is used to treat moderate to severe dermatosis of the scalp.

January 15, 2013

While replacing a single combination pill for HIV with generics would save the healthcare system money, it could also diminish the effectiveness of treatment, a new study suggests.

NEW YORK — While replacing a single combination pill for HIV with generics would save the healthcare system money, it could also diminish the effectiveness of treatment, a new study suggests.

The study, led by investigators at the Massachusetts General Hospital and Weill Cornell Medical College, and published in the Jan. 15 issue of Annals of Internal Medicine, found $1 billion in potential savings, but the more complicated treatment regimen might result in more patients missing doses and a loss of drug effectiveness.

December 28, 2012

Solidifying Perrigo’s leadership position in topical foam-based generic prescription pharmaceuticals, the company announced it has signed a definitive merger agreement and completed the acquisition of Cobrek Pharmaceuticals.

ALLEGAN, Mich. — Solidifying Perrigo’s leadership position in topical foam-based generic prescription pharmaceuticals, the company announced it has signed a definitive merger agreement and completed the acquisition of Cobrek Pharmaceuticals, a privately-held, Chicago-based drug development company, for approximately $45 million.

December 14, 2012

The Food and Drug Administration has approved a new leukemia drug made by Ariad Pharmaceuticals, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new leukemia drug made by Ariad Pharmaceuticals, the agency said Friday.

The FDA announced the approval of Iclusig (ponatinib) to treat chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia, also known respectively as CML and Ph+ ALL.

November 28, 2012

The Food and Drug Administration has approved a drug from Perrigo and Cobrek Pharmaceuticals for treating scalp conditions.

ALLEGAN, Mich. — The Food and Drug Administration has approved a drug from Perrigo and Cobrek Pharmaceuticals for treating scalp conditions.

Perrigo said that Cobrek, with which it is partnering, had received approval for betamethasone validate foam in the 0.12% strength. The drug is a generic version of Luxiq foam, made by GlaxoSmithKline subsidiary Stiefel Labs, and is used to treat corticosteroid-responsive skin conditions of the scalp, also known as scalp psoriasis.

The branded version of the drug has annual sales of about $40 million, according to Perrigo.

November 27, 2012

Ranbaxy Labs has recalled more than three dozen lots of its generic version of a cholesterol-lowering statin drug due to the possible presence of foreign particles, the company said.

NEW YORK — Ranbaxy Labs has recalled more than three dozen lots of its generic version of a cholesterol-lowering statin drug due to the possible presence of foreign particles, the company said.

October 19, 2012

The Food and Drug Administration has given tentative approval to a new drug for HIV made by an Indian company.

SILVER SPRING, Md. — The Food and Drug Administration has given tentative approval to a new drug for HIV made by an Indian company.

FDA records show that the agency gave tentative approval tablets and oral suspension that combine lamivudine, nevirapine and zidovudine in the 30-mg/50-mg/60-mg strength.

September 17, 2012

The Food and Drug Administration has approved a generic ulcer treatment made by Wockhardt, the Indian drug maker said Monday.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic ulcer treatment made by Wockhardt, the Indian drug maker said Monday.

Wockhardt announced the approval and launch of lansoprazole delayed-release capsules in the 15-mg and 30-mg strengths. The drug is a generic version of Prevacid, which Takeda markets in the United States.

The drug has a market of about $700 million in the United States, according to IMS Health.

September 13, 2012

The Food and Drug Administration has approved a generic psychiatric drug made by Lupin Pharmaceuticals, Lupin said Thursday.

BALTIMORE — The Food and Drug Administration has approved a generic psychiatric drug made by Lupin Pharmaceuticals, Lupin said Thursday.

The Indian drug maker announced the approval of escitalopram tablets in the 5-mg, 10-mg and 20-mg strengths, used for acute and maintenance treatment of major depressive disorder in adults and adolescents and for acute treatment of general anxiety disorder in adults.

September 4, 2012

In what could symbolize the so-called "patent cliff" that an executive from healthcare market research firm IMS Health spoke of at a recent trade show, a regional mass merchandise chain is taking what used to be the world's top-selling drug and giving it away for free.

GRAND RAPIDS, Mich. — In what could symbolize the so-called "patent cliff" that an executive from healthcare market research firm IMS Health spoke of at a recent trade show, a regional mass merchandise chain is taking what used to be the world's top-selling drug and giving it away for free.

March 23, 2012

Lawmakers are going after companies that they say have sought to take advantage of drug shortages by buying drugs in short supply and then reselling them at higher prices, according to published reports.

NEW YORK — Lawmakers are going after companies that they say have sought to take advantage of drug shortages by buying drugs in short supply and then reselling them at higher prices, according to published reports.

April 15, 2011

The main trade group representing branded drug makers gave an award to two Merck scientists who helped discover an oral medication for Type 2 diabetes.

JERSEY CITY, N.J. — The main trade group representing branded drug makers gave an award to two Merck scientists who helped discover an oral medication for Type 2 diabetes.

March 31, 2011

A drug used to treat diabetes also may prevent it, according to a new study published in the journal Experimental Biology and Medicine.

CLEVELAND — A drug used to treat diabetes also may prevent it, according to a new study published in the journal Experimental Biology and Medicine.

Researchers at Case Western Reserve University took specially bred obese, prediabetic rats and gave them either Merck’s Januvia (sitagliptin), placebo or glyburide, an older diabetes drug. Both of the diabetes drugs lowered blood-glucose levels after the rats had eaten, but only Junuvia raised the total output of insulin by the pancreas while lowering levels of glucagon.

November 15, 2010

The Food and Drug Administration on Monday teamed up with the Centers for Disease Control...

SILVER SPRING, Md. — The Food and Drug Administration on Monday teamed up with the Centers for Disease Control and Prevention and other healthcare professionals, government, academic, international and industry partners to support Get Smart About Antibiotics Week, Nov. 15 to 21, as part of a joint effort to encourage the appropriate use of antibiotics.