Content about Enantiopure drugs

March 31, 2014

In an effort to curb abuse of over-the-counter cold and cough medications by minors, Washington Gov. Jay Inslee on Friday signed legislation — House Bill 2163 — that places an age restriction on the purchase of dextromethorphan.

OLYMPIA, Wash. — In an effort to curb abuse of over-the-counter cold and cough medications by minors, Washington Gov. Jay Inslee on Friday signed legislation — House Bill 2163 — that places an age restriction on the purchase of dextromethorphan.

March 13, 2014

Using azithromycin and levofloxacin increases the risk of cardiac arrhythmia and death, according to a study of U.S. veterans.

COLUMBIA, S.C. — Using azithromycin and levofloxacin increases the risk of cardiac arrhythmia and death, according to a study of U.S. veterans.

The research was published in the March/April issue of Annals of Family Medicine.

February 4, 2014

Reps. Bill Johnson, R-Ohio, and Bruce Braley, D-Iowa, last week introduced bipartisan legislation — the Preventing Abuse of Cough Medicine Treatment Act — that would help combat the abuse of dextromethorphan by placing an age restriction on its purchase.

WASHINGTON — Reps. Bill Johnson, R-Ohio, and Bruce Braley, D-Iowa, last week introduced bipartisan legislation — the Preventing Abuse of Cough Medicine Treatment Act — that would help combat the abuse of dextromethorphan by placing an age restriction on its purchase. 

January 13, 2014

The Consumer Healthcare Products Association on Friday pledged its support behind the introduction of legislation by Rep. Paul Harris, R-Wash., that would prohibit pharmacies or retail distributors from selling over-the-counter cough medicines containing dextromethorphan to those younger than 18 years without a prescription.

WASHINGTON — The Consumer Healthcare Products Association on Friday pledged its support behind the introduction of legislation by Rep. Paul Harris, R-Wash., that would prohibit pharmacies or retail distributors from selling over-the-counter cough medicines containing dextromethorphan to those younger than 18 years without a prescription. CHPA says the bill, H.B. 2163, is a step toward preventing teen abuse of the medicines containing DXM. 

December 19, 2013

Abuse of the cough ingredient dextromethorphan among high school seniors is down, according to this year’s Monitoring the Future survey, which measures drug use and attitudes among the nation’s eighth-, 10th- and 12th-graders.

ROCKVILLE, Md. — Abuse of the cough ingredient dextromethorphan among high school seniors is down, according to this year’s Monitoring the Future survey, which measures drug use and attitudes among the nation’s eighth-, 10th- and 12th-graders. Approximately 5% of seniors reported abuse of dextromethorphan, down from 6.9% in 2006, the first year it was measured by the survey.

September 30, 2013

New York Gov. Andrew Cuomo on Friday signed legislation to prohibit pharmacies and stores from selling dextromethorphan to any person younger than 18 years unless they have a prescription.

ALBANY, N.Y. — New York Gov. Andrew Cuomo on Friday signed legislation to prohibit pharmacies and stores from selling dextromethorphan to any person younger than 18 years unless they have a prescription.

“This legislation will combat the growing trend of DXM abuse by preventing young people from easily purchasing products that contain DXM,” Cuomo stated. “The overuse of this drug can lead to terrible consequences, so by limiting access to this substance, this new law will prevent tragedies and protect the health of our children.”

August 15, 2013

Silvergate Pharmaceuticals announced that the Food and Drug Administration approved Epaned (enalapril maleate powder for oral solution) to treat hypertension in people 1 month and older.

DENVER — Silvergate Pharmaceuticals Inc. today announced that the Food and Drug Administration approved Epaned (enalapril maleate powder for oral solution) to treat hypertension (high blood pressure) in people one month and older. Enalapril is one of the most commonly prescribed medicines in the United States to treat high blood pressure.

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.

March 22, 2013

Sens. Bob Casey, D-Pa., and Lisa Murkowski, R-Ark., on Friday introduced the Preventing Abuse of Cough Treatments Act of 2013, which would require retailers to restrict the sale of dextromethorphan-containing products to adults.

WASHINGTON — Sens. Bob Casey, D-Pa., and Lisa Murkowski, R-Ark., on Friday introduced the Preventing Abuse of Cough Treatments Act of 2013, which would require retailers to restrict the sale of dextromethorphan-containing products to adults. The bill also would restrict the sale of raw, bulk DXM to FDA-approved entities. 

Many retailers have age restrictions on the sale of DXM products already in place; and similar legislation to this has been enforced in California since 2012. 

January 22, 2013

The Food and Drug Administration has approved a generic contraceptive made by Lupin Pharmaceuticals, the drug maker said Tuesday.

BALTIMORE — The Food and Drug Administration has approved a generic contraceptive made by Lupin Pharmaceuticals, the drug maker said Tuesday.

Lupin announced the approval of levonorgestrel and ethinyl estradiol tablets in the 0.1 mg/0.02 mg strength, a generic version of Watson Labs' Lutera.

Lutera had sales of about $103.6 million during the 12-month period that ended in September 2012, according to IMS Health.

December 28, 2012

Mylan on Friday announced that its partner Famy Care has received final approval from the Food and Drug Administration for its abbreviated new drug application for levonorgestrel and ethinyl estradiol Tablets USP in the 0.15mg/0.03mg strength.

PITTSBURGH — Mylan on Friday announced that its partner Famy Care has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for levonorgestrel and ethinyl estradiol tablets USP in the 0.15mg/0.03mg strength.

The product is a generic version of Teva Branded Pharmaceutical Products' Nordette 28 Tablets, a form of oral contraception. The new product will be distributed in the United States by Mylan Pharmaceuticals, and the company is shipping the product immediately.

December 27, 2012

The National Institute on Drug Abuse last week released the 2012 Monitoring the Future survey, finding that 5.6% of high school seniors, 3% of eighth graders and 4.7% of tenth graders abused over-the-counter cough and cold medicines containing dextromethorphan, bringing the overall average to under 5%.

BETHESDA, Md. — The National Institute on Drug Abuse last week released the 2012 Monitoring the Future survey, finding that 5.6% of high school seniors abused over-the-counter cough and cold medicines containing dextromethorphan, a rate that has held relatively steady over the past five years. Abuse of DXM products was reported to be 3% among eighth graders and 4.7% among tenth graders, bringing the overall average to under 5%.

November 29, 2012

In 2011 and 2012, the steady surge of blockbuster pharmaceuticals falling off the patent cliff became a stampede. An astonishing number of big-selling drugs that had established and sustained branded drug makers’ profits for years fell victim to the expiration of their patent lives and market exclusivity, roiling the pharmaceutical marketplace and redefining the pricing model for many of the most widely prescribed classes of medicines.


In 2011 and 2012, the steady surge of blockbuster pharmaceuticals falling off the patent cliff became a stampede. An astonishing number of big-selling drugs that had established and sustained branded drug makers’ profits for years fell victim to the expiration of their patent lives and market exclusivity, roiling the pharmaceutical marketplace and redefining the pricing model for many of the most widely prescribed classes of medicines.


November 8, 2012

Members of a prescription-drug program offered by Humana to Medicare beneficiaries will soon be able to obtain hypertension drugs from Walmart for a penny.

BENTONVILLE, Ark. — Members of a prescription drug program offered by Humana to Medicare beneficiaries will soon be able to obtain hypertension drugs from Walmart for a penny.

That's right: $0.01.

September 20, 2012

Drug maker Dr. Reddy's Labs has launched a generic antibiotic drug, the company said Thursday.

HYDERABAD, India — Drug maker Dr. Reddy's Labs has launched a generic antibiotic drug, the company said Thursday.

The India-based company announced the launch of amoxicillin tablets, capsules and oral suspension. The tablets are being launched in the 500-mg and 875-mg strengths, while the capsules are in the 250-mg and 500-mg strengths, and the oral suspension is in the 125-mg-, 200-mg-, 250-mg- and 400-mg-per-5-mL strengths.

June 25, 2012

The Food and Drug Administration has approved a generic drug for attention deficit hyperactivity disorder made by Actavis, the drug maker said Monday.

MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic drug for attention deficit hyperactivity disorder made by Actavis, the drug maker said Monday.

Actavis, whose parent company was recently acquired by Watson Pharmaceuticals, announced the approval of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, also known as mixed-amphetamine salts ER capsules.

May 29, 2012

A unit of generic drug maker Mylan has settled with Sunovion Pharmaceuticals over a drug used to treat chronic obstructive pulmonary disease and asthma.

PITTSBURGH — A unit of generic drug maker Mylan has settled with Sunovion Pharmaceuticals over a drug used to treat chronic obstructive pulmonary disease and asthma.

Mylan announced Tuesday that it had reached a settlement in a patent litigation suit that Sunovion, which used to operate under the name Sepracor, had filed against Dey Pharma, now known as Mylan Specialty, concerning the drug Xopenex (levalbuterol hydrochloride).

February 29, 2012

The Food and Drug Administration has approved a drug for epilepsy made by Hi-Tech Pharmacal, the drug maker said Wednesday.

AMITYVILLE, N.Y. — The Food and Drug Administration has approved a drug for epilepsy made by Hi-Tech Pharmacal, the drug maker said Wednesday.

Hi-Tech announced the approval of levetiracetam oral solution in the 100 mg-per-milliliter strength. The drug is a generic version of UCB Pharma's Keppra oral solution and is used to treat partial onset seizures in people ages 16 years and older.

Various versions of the drug had sales of $62 million in 2011, according to IMS Health. Hi-Tech said it plans to launch the drug in May.

January 3, 2011

The Food and Drug Administration approved three drugs made by Glenmark Generics last month and gave tentative approval to a fourth, the Indian generic drug maker said.

MUMBAI, India — The Food and Drug Administration approved three drugs made by Glenmark Generics last month and gave tentative approval to a fourth, the Indian generic drug maker said.

March 3, 2010

The U.S. District Court for the District of Columbia has upheld a decision by the...