Content about Chemistry

February 25, 2013

Amneal Pharmaceuticals has received approval from the Food and Drug Administration for a drug to treat opioid dependence.

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has received approval from the Food and Drug Administration for a drug to treat opioid dependence.

Amneal announced Monday the approval of buprenorphine hydrochloride and naloxone hydrochloride sublingual tablets, a generic version of Reckitt Benckiser Healthcare's Suboxone.

Suboxone had sales of $1.5 billion in 2012, according to IMS Health.

 

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 25, 2013

Mylan has begun shipping a generic drug for cholesterol, the company said Monday.

PITTSBURGH — Mylan has begun shipping a generic drug for cholesterol, the company said Monday.

Mylan said a subsidiary had started shipping fenofibrate capsules in the 43-mg and 130-mg strengths. The drug is a generic version of Lupin Atlantis Holdings Antara, used in combination with diet to reduce elevated bad cholesterol and other blood lipids and increase beneficial HDL cholesterol in patients with primary hypercholesterolemia or mixed dyslipidemia.

February 22, 2013

The Food and Drug Administration has approved a new treatment for late-stage breast cancer, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for late-stage breast cancer, the agency said Friday.

The FDA announced the approval of Genentech's Kadcyla (ado-trastuzumab emtansine) for HER2-positive breast cancer that has spread to other parts of the body. HER2 is a protein involved in the growth of normal cells but found in increased amounts in some kinds of cancer cells, which contributes to cancer cell growth and survival. Genentech is the U.S. subsidiary of Swiss drug maker Roche.

February 21, 2013

Organix-South has introduced TheraNeem Naturals Liquid Neem Soap, a neem and castile soap made with certified organic oils and no harsh detergents, which can compromise the skin and hair, the company announced.

BOWLING GREEN, Fla. — Organix-South has introduced TheraNeem Naturals Liquid Neem Soap, a neem and castile soap made with certified organic oils and no harsh detergents, which can compromise the skin and hair, the company announced this week. The liquid soap is packaged in 16-fl.-oz. bottles and comes in two varieties: unscented and lavendar. Neem liquid soap is free of parabens and sulfates; plus, the products are cruelty-free and vegan.

February 19, 2013

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

HYDERABAD, India — The Food and Drug Administration has approved a generic diabetes drug made by Aurobindo Pharma, the drug maker said.

Aurobindo announced the approval of pioglitazone tablets in the 15 mg, 30 mg and 45 mg strengths, in addition to the earlier tentative approval it received for pioglitazone and metformin hydrochloride tablets in the 15 mg/500 mg and 15 mg/850 mg strengths.

February 19, 2013

Drug maker Gilead Sciences has recalled a single lot of an injected drug used to treat an opportunistic infection in AIDS patients due to the presence of foreign matter, the company said.

FOSTER CITY, Calif. — Drug maker Gilead Sciences has recalled a single lot of an injected drug used to treat an opportunistic infection in AIDS patients due to the presence of foreign matter in some vials, the company said.

Gilead announced the voluntary recall of lot B120217A of Vistide (cidofovir), an injected drug used to treat cytomegalovirus retinitis in patients with AIDS, due to particulate matter.

February 19, 2013

Two-hundred-ninety billion dollars. That’s the number often thrown around when health experts talk about what medication nonadherence costs patients, insurers, health plan payers and the U.S. economy every year. And of course, dollar estimates say nothing about the impact that nonadherence has on patients and their families in higher chronic and acute disease rates, reduced quality of life and shortened lifespans.

So the failure by patients to take their meds as prescribed is a big deal. And it’s gotten a lot of attention from payers in the last couple of years because it’s one of the most obvious levers to pull as public and private health plan sponsors struggle to get a grip on the astronomical and still-expanding cost of health care in the United States.

Two-hundred-ninety billion dollars. That’s the number often thrown around when health experts talk about what medication nonadherence costs patients, insurers, health plan payers and the U.S. economy every year. And of course, dollar estimates say nothing about the impact that nonadherence has on patients and their families in higher chronic and acute disease rates, reduced quality of life and shortened lifespans.

February 19, 2013

Sergeant's Pet Care Products has launched a generic version of a commonly used spray for killing fleas and ticks in dogs and cats, the company said Tuesday.

OMAHA, Neb. — Sergeant's Pet Care Products has launched a generic version of a commonly used spray for killing fleas and ticks in dogs and cats, the company said Tuesday.

Sergeant's announced the launch of Pronyl, a version of Sanofi's Frontline. Pronyl uses the same active ingredient, Fipronil, but also uses what the company calls Bag-on-Valve technology that allows a continuous and quiet spray from any angle.

February 15, 2013

Jewelry maker Tiffany & Co. is suing Costco Wholesale, alleging that the club retailer falsely marketed diamond engagement rings as coming from the New York-based jeweler, according to published reports.

NEW YORK — Jewelry maker Tiffany & Co. is suing Costco Wholesale, alleging that the club retailer falsely marketed diamond engagement rings as coming from the New York-based jeweler, according to published reports.

News media reported that Tiffany filed suit against Issaquah, Wash.-based Costco in the Federal District Court in Manhattan.

February 15, 2013

Elmer’s ProBond Advanced adhesive is being promoted as a multipurpose glue that’s as strong as a polyurethane competitor, but without the foamy mess.

COLUMBUS, Ohio — A sticky situation just got stickier.

Elmer’s Products has introduced Elmer’s ProBond Advanced adhesive, which is being promoted as a multipurpose glue that’s as strong as a polyurethane competitor, but without the foamy mess.

February 14, 2013

Actavis and Mallinckrodt have reached a settlement concerning the former's generic version of an opioid painkiller made by the latter, Actavis said Thursday.

PARSIPPANY, N.J. — Actavis and Mallinckrodt have reached a settlement concerning the former's generic version of an opioid painkiller made by the latter, Actavis said Thursday.

The companies settled patent lawsuit regarding Actavis' generic version of Mallinckrodt's Exalgo (hydromorphone hydrochloride) extended-release tablets in the 32-mg strength. The companies settled litigation regarding the 8-mg, 12-mg and 16-mg strengths last month.

February 14, 2013

Mustela, a European skin care and stretch marks brand, recently introduced three products in a sun care range for babies.

NEW YORK — Mustela, a European skin care and stretch marks brand, recently introduced three products in a sun care range for babies.

The new Broad Spectrum SPF 50+ Mineral Sunscreen Lotion and Broad Spectrum SPF 50+ Mineral Sunscreen Stick are tested under the most recent FDA requirements for sunscreen and have both been awarded the Melanoma International Foundation’s Seal of Approval, the company stated.


Mustela’s formulations are 100% mineral, with naturally derived sunscreen filters titanium dioxide and zinc oxide.



February 14, 2013

The Food and Drug Administration has accepted the resubmission of a regulatory approval application from United Therapeutics for a drug to treat pulmonary arterial hypertension, the drug maker said.

SILVER SPRING, Md. — The Food and Drug Administration has accepted the resubmission of a regulatory approval application from United Therapeutics for a drug to treat pulmonary arterial hypertension, the drug maker said Thursday.

The FDA originally declined to approve the drug, treprostinil diolamine extended-release tablets, in a letter submitted to the company in October 2012.

The agency plans to decide whether or not to approve the drug in March of this year, United Therapeutics said.

February 13, 2013

Brookshire Grocery has joined the Environmental Protection Agency's GreenChill partnership, the supermarket chain said.

TYLER, Texas — Brookshire Grocery Co. has joined the Environmental Protection Agency's GreenChill partnership, the supermarket chain said.

BGC said that by joining the initiative, it will work toward sustainability and protecting consumers' health and the environment. According to the EPA, a typical supermarket leaks about 1,000 pounds of refrigerant gas into the atmosphere each year, and BGC said it would work to reduce those emissions.

February 8, 2013

The Food and Drug Administration has approved a generic diabetes drug made by Macleods Pharma, according to agency records.

SILVER SPRING, Md. - The Food and Drug Administration has approved a generic diabetes drug made by Macleods Pharma, according to agency records.

The FDA approved Macleods' pioglitazone hydrochloride tablets in the 15 mg, 30 mg and 45 mg strengths.

The drug is a generic version of Takeda's Actos, branded and generic versions of which had sales of about $2.7 billion during the 12-month period that ended in August 2012, according to IMS Health.

February 8, 2013

The Food and Drug Administration has given tentative approval to a generic drug for treating hypertension, according to agency records.

 SILVER SPRING, Md. - The Food and Drug Administration has given tentative approval to a generic drug for treating hypertension, according to agency records.

The FDA granted tentative approval to Dr. Reddy's Labs' valsartan tablets in the 40 mg, 80 mg, 160 mg and 320 mg strengths.

The drug is a generic version of Novartis' Diovan. Various versions of the drug had sales of $1.6 billion during the 12-month period that ended in June, according to IMS Health.

February 8, 2013

Surprise inspections at 40 compounding pharmacies in Massachusetts last fall have led to 10 being ordered to stop sterile compounding, according to published reports.

NEW YORK - Surprise inspections at 40 compounding pharmacies in Massachusetts last fall have led to 10 being ordered to stop sterile compounding, according to published reports.

State health authorities sent cease-and-desist letters to 11 pharmacies, telling 10 to stop compounding altogether and one to stop compounding the drug sildenafil citrate. Twenty-one other pharmacies were allowed to continue compounding, but were cited for minor violations.

February 7, 2013

An insomnia drug made by Purdue Pharma "significantly" reduced the time it took patients to return to sleep after they'd woke up in the middle of the night, according to a new study.

STAMFORD, Conn. — An insomnia drug made by Purdue Pharma "significantly" reduced the time it took patients to return to sleep after they'd woke up in the middle of the night, according to a new study.

The placebo-controlled study, published in the journal Sleep, tested the drug Intermezzo (zolpidem tartrate) sublingual tablets on 295 adults with primary insomnia and difficulty returning to sleep after waking up in the middle of the night. Purdue said Intermezzo was the only drug approved by the Food and Drug Administration for treating such patients.

February 7, 2013

Sam's Club will offer free heart health screenings at 563 of its stores on Saturday, the club retailer said.

BENTONVILLE, Ark. — Sam's Club will offer free heart health screenings at 563 of its stores on Saturday, the club retailer said.

The screenings, taking place at stores with pharmacies, will include tests valued at up to $100 for glucose, total cholesterol, high-density lipoprotein cholesterol, blood pressure, body mass index and vision screenings.

February 6, 2013

The Food and Drug Administration has approved a regulatory approval application from Elite Pharmaceuticals for an opioid painkiller, the drug maker said Wednesday.

NORTHVALE, N.J. — The Food and Drug Administration has approved a regulatory approval application from Elite Pharmaceuticals for an opioid painkiller, the drug maker said Wednesday.

Elite announced the FDA approval of its supplemental application for the manufacture and packaging of naltrexone hydrochloride tablets in the 50-mg strength. The company said the approval would allow it to start manufacturing and packaging the drug for its sales and marketing partner, Mikah Pharma, from which it bought rights to the drug in September 2010.

February 6, 2013

Adults should consume less than 2,000 mg of sodium, or 5 grams of salt, and at least 3,510 mg of potassium per day, according to new guidelines issued by the World Health Organization.

GENEVA — Adults should consume less than 2,000 mg of sodium, or 5 grams of salt, and at least 3,510 mg of potassium per day, according to new guidelines issued by the World Health Organization last week. A person with either elevated sodium levels and low potassium levels could be at risk of raised blood pressure which increases the risk of heart disease and stroke.

Currently, most people consume too much sodium and not enough potassium.

February 5, 2013

CVS Caremark is marking American Heart Month by encouraging heart-healthy behavior in February, the company said Tuesday.

WOONSOCKET, R.I. — CVS Caremark is marking American Heart Month by encouraging heart-healthy behavior in February, the company said Tuesday.

February 5, 2013

A JAMA report released suggested a high intake of supplemental calcium is associated with an increased risk of cardiovascular disease death in men was criticized by several dietary supplement agencies for being inconclusive.

CHICAGO — A JAMA report released Monday afternoon that suggested a high intake of supplemental calcium is associated with an increased risk of cardiovascular disease death in men was criticized by several dietary supplement agencies for being inconclusive. According to the Council for Responsible Nutrition's most recent survey of U.S. adults, 17% indicated they take a calcium supplement.

February 5, 2013

The National Community Pharmacists Association submitted comments to the Food and Drug Administration urging the agency to preserve access to hydrocodone-containing pain relief products, as FDA considers moving the medications from the Drug Enforcement Administration’s Schedule III list of controlled substances to the more restrictive Schedule II list.

ALEXANDRIA, Va. — The National Community Pharmacists Association on Monday submitted comments to the Food and Drug Administration urging the agency to preserve access to hydrocodone-containing pain relief products, as FDA considers moving the medications from the Drug Enforcement Administration’s Schedule III list of controlled substances to the more restrictive Schedule II list.