Content about Organic chemistry

January 8, 2014

The Food and Drug Administration has approved a new drug made by Bristol-Myers Squibb and AstraZeneca for treating Type 2 diabetes, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by Bristol-Myers Squibb and AstraZeneca for treating Type 2 diabetes, the agency said Wednesday.

The FDA announced the approval of Farxiga (dapagliflozin) tablets, designed for use with exercise and dietary adjustments to control blood sugar. Type 2 diabetes affects about 24 million people in the United States, accounting for more than 90% of diabetes cases.

January 6, 2014

Amneal Pharmaceuticals has launched an authorized generic version of a recently launched drug for gastroesophageal reflux disease, the company said.

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has launched an authorized generic version of a recently launched drug for gastroesophageal reflux disease, the company said Monday.

December 27, 2013

The Food and Drug Administration has approved an HIV pill made by Gilead Sciences for patients who are switching from other therapy regimens, the company said.

FOSTER CITY, Calif. — The Food and Drug Administration has approved an HIV pill made by Gilead Sciences for patients who are switching from other therapy regimens, the company said.

Gilead said the FDA approved its single-pill regimen, Complera (emtricitabine; rilpivirine; tenofovir disoproxil fumarate) for use in adult patients who have suppressed their infections on stable antiretroviral regimens and are replacing their current regimens. The FDA originally approved the drug in 2011.

December 26, 2013

Heading into 2014, there are a number of growth drivers across the digestives space.

Heading into 2014, there are a number of growth drivers across the digestives space. There’s the possible switch of Nexium into over-the-counter aisles, brands like Imodium are experiencing a resurgence with their return to the shelves, and Chattem is bringing the venerable Rolaids brand back into the digestives fold.

December 23, 2013

A federal court decision paves the way for Amneal Pharmaceuticals and its South Korean partnering company to market a drug for treating gastroesophageal reflux disease, the companies said Monday.

BRIDGEWATER, N.J. — A federal court decision paves the way for Amneal Pharmaceuticals and its South Korean partnering company to market a drug for treating gastroesophageal reflux disease, the companies said Monday.

December 23, 2013

The Food and Drug Administration has approved a new drug made by United Therapeutics for treating pulmonary arterial hypertension, the company said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by United Therapeutics for treating pulmonary arterial hypertension, the company said Monday.

The FDA approved Orenitram (treprostinil) extended-release tablets for treating certain PAH patients to improve exercise capacity. PAH is a disease in which abnormally high blood pressure in the arteries of the lungs causes the right side of the heart to work harder than normal, according to the National Library of Medicine.

December 18, 2013

Lupin has launched a generic drug for treating HIV, following its victory in a patent-infringement suit in federal court, the Indian drug maker said Wednesday.

BALTIMORE — Lupin has launched a generic drug for treating HIV, following its victory in a patent-infringement suit in federal court, the Indian drug maker said Wednesday.

Lupin's U.S. subsidiary launched its generic version of ViiV Healthcare's Trizivir (abacavir sulfate; lamivudine; zidovudine) tablets in the 300-mg/150-mg/300-mg strength. The launch follows a ruling by the U.S. District Court for the District of Delaware that the drug did not infringe on Viiv's patent.

December 17, 2013

Greenstone has launched a version of a drug used to treat fungal infections, the company said.

PEAPACK, N.J. — Greenstone has launched a version of a drug used to treat fungal infections, the company said.

Greenstone, the generics subsidiary of Pfizer, announced the introduction of voriconazole for oral suspension, an authorized generic version of Pfizer's Vfend. Authorized generics are branded drugs sold at a discount under their generic names.

Greenstone is selling the drug in the 40 mg-per-milliliter strength. Vfend had sales of about $17.1 million during the 12-month period that ended in June, according to IMS Health.

 

December 4, 2013

The availability of new generic drugs for treating HIV will erode sales of HIV antiretroviral drugs into the next decade in developed countries, according to a new report.

BURLINGTON, Mass. — The availability of new generic drugs for treating HIV will erode sales of HIV antiretroviral drugs into the next decade in developed countries, according to a new report.

Healthcare market research firm Decision Resources released the report Wednesday, showing that sales of antiretroviral drugs in the United States, France, Germany, the United Kingdom, Spain, Italy and Japan would be $13.1 billion in 2022, down from 2012's $13.4 billion.

December 3, 2013

Impax Labs has settled a patent-infringement suit filed by Purdue Pharma concerning the opioid painkiller OxyContin, Impax said Tuesday.

HAYWARD, Calif. — Impax Labs has settled a patent-infringement suit filed by Purdue Pharma concerning the opioid painkiller OxyContin, Impax said Tuesday.

December 3, 2013

Inergetics and the Podiatree Co. on Tuesday launched Intrinsix, a podiatry-exclusive nerve health support supplement enriched with calcium and vitamin D.

NEWARK, N.J. — Inergetics and the Podiatree Co. on Tuesday launched Intrinsix, a podiatry-exclusive nerve health support supplement enriched with calcium and vitamin D.

Developed alongside pharmacist, Robert Graci, Inergetics has created a unique formula to support healthy nerve function and specifically help diabetic patients who experience nerve-related symptoms in their extremities, which include tingling, pain, burning and loss of sensation, the company stated. 

December 2, 2013

Shionogi and Egalet have entered a deal worth up to $425 million for the development of abuse-deterrent opioid painkillers, Egalet said.

MALVERN, Pa. — Shionogi and Egalet have entered a deal worth up to $425 million for the development of abuse-deterrent opioid painkillers, Egalet said.

The deal centers on the development and potential commercialization of experimental drugs containing the opioid painkiller hydrocodone.

December 2, 2013

The Food and Drug Administration has approved a generic version of a drug for schizophrenia and bipolar disorder made by Jubilant Life Sciences, the Indian drug maker said.

NOIDA, India — The Food and Drug Administration has approved a generic version of a drug for schizophrenia and bipolar disorder made by Jubilant Life Sciences, the Indian drug maker said.

Jubilant announced the approval of quetiapine fumarate tablets in the 25-mg strength. The drug is a generic version of AstraZeneca's Seroquel.

Various versions of the drug have annual sales of about $59 million, according to IMS Health.

 

December 2, 2013

Pfizer on Monday announced that a wholly-owned Polish subsidiary of Pfizer has acquired the rights to Polocard, a low-dose aspirin (acidum acetylsalicylicum), and the leading over-the-counter brand for heart attack prevention in Poland, from ZF Polpharma SA.

NEW YORK — Pfizer on Monday announced that a wholly-owned Polish subsidiary of Pfizer has acquired the rights to Polocard, a low-dose aspirin (acidum acetylsalicylicum), and the leading over-the-counter brand for heart attack prevention in Poland, from ZF Polpharma SA.

November 27, 2013

Treatment of influenza with antiviral medicines like Tamiflu and Relenza may improve survival rates in children, according to a study published Nov. 25 in Pediatrics.

ELK GROVE VILLAGE, Ill. — Treatment of influenza with such antiviral medicines as Tamiflu and Relenza may improve survival rates in children, according to a study published on Nov. 25 in Pediatrics

Researchers from the California Department of Public Health analyzed data abstracted from medical records to characterize the outcomes of pediatric patients hospitalized with the flu between April 3, 2009 and September 30, 2012. 

November 26, 2013

The Food and Drug Administration has accepted Purdue Pharma's regulatory approval application for a new opioid drug, Purdue said Tuesday.

STAMFORD, Conn. — The Food and Drug Administration has accepted Purdue Pharma's regulatory approval application for a new opioid drug, Purdue said Tuesday.

The drug maker announced the FDA's acceptance of its application for Targiniq (oxycodone hydrochloride; naloxone hydrochloride) controlled-release tablets. The drug combines oxycodone with the opioid agonist nalxone.

November 26, 2013

QRxPharma has resubmitted its regulatory approval application for an opioid painkiller for which it has sought Food and Drug Administration approval since 2011, the company said Tuesday.

BEDMINSTER, N.J. — QRxPharma has resubmitted its regulatory approval application for an opioid painkiller for which it has sought Food and Drug Administration approval since 2011, the company said Tuesday.

The Australian drug maker announced the resubmission of its application for Moxduo, a pill that combines oxycodone and morphine.The FDA is expected to schedule an advisory committee meeting to review the application for May 2014.

November 25, 2013

The November/December 2013 Cough, Cold and Flu Ingredient Guide breaks down the indication, ingredients, purpose and dosage of Robitussin Maximum Strength, NyQuil Severe Cold & Flu, Theraflu Warming Caplets, Coricidin HBP Cold & Flu, Tylenol Cold & Flu Severe, Hyland's Defend Severe Cold & Flu, Similasan Mucus Relief and Splintek Night Guard.

The November/December 2013 Cough, Cold and Flu Ingredient Guide breaks down the indication, ingredients, purpose and dosage of Robitussin Maximum Strength, NyQuil Severe Cold & Flu, Theraflu Warming Caplets, Coricidin HBP Cold & Flu, Tylenol Cold & Flu Severe, Hyland's Defend Severe Cold & Flu, Similasan Mucus Relief and Splintek Night Guard.

November 22, 2013

The Food and Drug Administration has approved a drug made by Bayer HealthCare Pharmaceuticals for treating thyroid cancer, the agency said Friday.

SILVER SPRING, Md. – The Food and Drug Administration has approved a drug made by Bayer HealthCare Pharmaceuticals for treating thyroid cancer, the agency said Friday.

The FDA announced the approval of Nexavar (sorafenib) to treat late-stage differentiated thyroid cancer. The drug was already approved for kidney and liver cancers. The drug works by limiting cancer cell growth and replication by inhibiting proteins within the cells.

November 22, 2013

The Food and Drug Administration has granted regular approval to a new drug made by Pfizer for treating a form of lung cancer, the drug maker said.

NEW YORK — The Food and Drug Administration has granted regular approval to a new drug made by Pfizer for treating a form of lung cancer, the drug maker said.

November 13, 2013

A new study conducted by researchers at CVS Caremark and Brigham and Women's Hospital explored the impact of genetic testing on prescribing patterns for cardiovascular therapy.

WOONSOCKET, R.I. — A new study conducted by researchers at CVS Caremark and Brigham and Women's Hospital explored the impact of genetic testing on prescribing patterns for cardiovascular therapy and found that there is an opportunity to improve upon the information physicians and patients receive on the evolving body of evidence for pharmacogenomics.

November 11, 2013

Indian drug maker Lupin has launched its generic version of a drug used to treat gastroesophageal reflux disease, the company said Monday.

BALTIMORE — Indian drug maker Lupin has launched its generic version of a drug used to treat gastroesophageal reflux disease, the company said Monday.

Lupin announced the launch of rabeprazole sodium extended-release tablets in the 20-mg strength, a generic version of Eisai's Aciphex. The Food and Drug Administration approved generic versions of Aciphex made by six companies on Friday.

Aciphex had sales of about $864.3 million during the 12-month period that ended in June, according to IMS Health.

 

November 8, 2013

Drug maker Eisai has launched a new version of a drug used to treat gastroesophageal reflux disease, the company said Friday.

WOODCLIFF LAKE, N.J. — Drug maker Eisai has launched a new version of a drug used to treat gastroesophageal reflux disease, the company said Friday.

Eisai announced the availability of Aciphex Sprinkle delayed-release capsules in the 5-mg and 10-mg strengths. The Food and Drug Administration approve the drug in March.

Aciphex Sprinkle capsules, which are approved for use in children aged 1 to 11 for up to 12 weeks, are designed to be broken open and sprinkled on soft food or liquid.

 

November 8, 2013

The Food and Drug Administration has approved six generic versions of a drug used to treat gastroesophageal reflux disease, or GERD, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved six generic versions of a drug used to treat gastroesophageal reflux disease, or GERD, the agency said Friday.

The FDA announced the approval of the first generic versions of Eisai's Aciphex (rabeprazole sodium) delayed-release tablets for patients aged 12 and older. The generic products are made by Dr. Reddy's Labs, Kremers Urban Pharmaceuticals, Lupin Pharmaceuticals, Mylan Pharmaceuticals, Teva Pharmaceuticals USA and Torrent Pharmaceuticals.

November 6, 2013

Noven Pharmaceuticals has launched a new drug for severe hot flashes nationwide, the company said.

NEW YORK — Noven Pharmaceuticals has launched a new drug for severe hot flashes nationwide, the company said.

The drug maker announced the availability of Brisdelle (paroxetine) capsules in the 7.5-mg strength, the first-ever non-hormonal drug approved by the Food and Drug Administration for moderate to severe hot flashes associated with menopause.