Content about Organochlorides

April 16, 2014

Dr. Reddy's Labs announced the launch of eszopiclone tablets (C-IV) in 1-mg, 2-mg and 3-mg form. The drug is the generic version of Lunesta (eszopiclone) tablets.

HYDERABAD, India — Dr. Reddy's Labs announced the launch of eszopiclone tablets (C-IV) in 1-mg, 2-mg and 3-mg form. The drug is the generic version of Lunesta (eszopiclone) tablets.

The Lunesta tablets brand and generic combined had sales in the United States of approximately $887 million for the most recent twelve months ending in January 2014, according to IMS Health. Dr. Reddy's eszopiclone tablets 1-mg is available in bottle counts of 30; 2-mg and 3-mg tablets are available in bottle counts of 100.

April 15, 2014

The Food and Drug Administration on Friday announced a meeting of the Nonprescription Drugs Advisory Committee on May 2 to discuss the potential switch of Merck's Singulair Allergy tablets.

SILVER SPRING, Md. — The Food and Drug Administration on Friday announced a meeting of the Nonprescription Drugs Advisory Committee on May 2 to discuss the potential switch of Merck's Singulair Allergy tablets. 

The proposed OTC use is "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: Nasal congestion, runny nose, itchy, watery eyes, sneezing, itching of the nose.” The applicant proposes to label the product for OTC use in adults 18 years and older. 

April 15, 2014

Greenstone, a generic pharmaceutical subsidiary of Pfizer, announced the introduction of amlodipine besylate/atorvastatin calcium tablets to its roster of products.

PEAPACK, N.J. — Greenstone, a generic pharmaceutical subsidiary of Pfizer, announced the introduction of amlodipine besylate/atorvastatin calcium tablets to its roster of products. The drug is the authorized generic versions of Caduet.

April 15, 2014

Mylan announced that it has launched eszopiclone tablets in 1 mg, 2 mg and 3 mg form.

PITTSBURGH — Mylan announced that it has launched eszopiclone tablets in 1 mg, 2 mg and 3 mg form. The drug — which is used for the treatment of insomnia — is the generic version of Lunesta from Sunovion Pharmaceuticals.

Mylan received final approval from the Food and Drug Administration for its abbreviated new drug application. Eszopiclone tablets had sales in the U.S. of approximately $851.8 million for the 12 months ending Dec 31, 2013, according to IMS Health.

 

April 15, 2014

Teva Pharmaceutical Industries announced the launch of a generic equivalent to Lunesta (eszopiclone tablets) in 1-,2- and 3-mg form in the United States.

JERUSALEM — Teva Pharmaceutical Industries announced the launch of a generic equivalent to Lunesta (eszopiclone tablets) in 1-,2- and 3-mg form in the United States. The drug is used to treat insomnia.

Lunesta tablets, which are marketed by Sunovion Pharmaceuticals, had annual sales of $852 million in the United States as of December 2013, according to IMS data.

 

March 25, 2014

The Food and Drug Administration last week approved Amneal Pharmaceuticals' abbreviated new drug application for atovaquone oral suspension USP, 750-mg/5-mL.

SILVER SPRING, Md. — The Food and Drug Administration last week approved Amneal Pharmaceuticals' abbreviated new drug application for atovaquone oral suspension USP, 750-mg/5-mL. 

Atovaquone is the generic equivalent of GlaxoSmithKline's Mepron, indicated for the prevention of Pneumocystis jiroveci pneumonia in patients who are intolerant to trimethoprim-sulfamethoxazole.

March 13, 2014

Bayer HealthCare LLC Animal Health division on Wednesday launched eight flea and tick treatments and control solutions, which are to be sold at pet specialty retail stores.

ORLANDO, Fla. — Bayer HealthCare LLC Animal Health division on Wednesday launched eight flea and tick treatments and control solutions, which are to be sold at pet specialty retail stores. The announcement was made at Global Pet Expo, the pet industry's largest annual trade show.

Four of the new products — Advantage Treatment Spray for dogs, Advantage Treatment Spray for cats, Advantage Treatment Shampoo for dogs and Advantage Treatment Shampoo for cats — aim to give pet owners an array of options for pest treatment.

March 3, 2014

Teva Pharmaceutical Industries announced the launch of Adasuve (loxapine) inhalation powder in a 10-mg dosage. The drug is the first and only orally inhaled medicine for the acute treatment of agitation associated with schizophrenia or bipolar disorder in adults.

JERUSALEM — Teva Pharmaceutical Industries announced the launch of Adasuve (loxapine) inhalation powder in a 10-mg dosage. The drug is the first and only orally inhaled medicine for the acute treatment of agitation associated with schizophrenia or bipolar disorder in adults.

February 18, 2014

This year, ECRM celebrates 20 years of successfully pairing buyers and sellers across the consumer packaged goods industry.

This year, ECRM celebrates 20 years of successfully pairing buyers and sellers across the consumer packaged goods industry. As part of that celebration, and in correlation to the ECRM Cough-Cold, Analgesics and Allergy event, DSN editors thought it’d be a good idea to look back through the last 20 years of the cough-cold business at retail.

January 21, 2014

Vivus and Auxilium Pharmaceuticals announced that the Food and Drug Administration has accepted a supplemental application that proposes to revise the Stendra (avanafil) prescribing information with efficacy and safety information from Study TA-501, entitled "A Randomized, Double-Blind, Placebo-Controlled Evaluation of Avanafil for On-Demand Treatment of Men with Erectile Dysfunction."

MOUNTAIN VIEW, Calif. — Vivus and Auxilium Pharmaceuticals on Tuesday announced that the Food and Drug Administration has accepted a supplemental application that proposes to revise the Stendra (avanafil) prescribing information with efficacy and safety information from Study TA-501, entitled "A Randomized, Double-Blind, Placebo-Controlled Evaluation of Avanafil for On-Demand Treatment of Men with Erectile Dysfunction." 

The PDUFA date for the supplemental filing is Sept. 20, 2014.

January 17, 2014

Nuvo Research on Friday announced that the U.S. Food and Drug Administration approved Mallinckrodt's new drug application for Pennsaid (diclofenac sodium topical solution) 2%

MISSISSAUGA, Ontario — Nuvo Research on Friday announced that the U.S. Food and Drug Administration approved Mallinckrodt's new drug application for Pennsaid (diclofenac sodium topical solution) 2%.

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.

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 22, 2013

Sandoz has launched an authorized generic version of a topical drug for treating actinic keratosis, the company said.

PRINCETON, N.J. — Sandoz has launched an authorized generic version of a topical drug for treating actinic keratosis, the company said.

Sandoz, the generics arm of Swiss drug maker Novartis, announced the launch of authorized generic diclofenac gel in the 3% strength. The drug is a version of PharmaDerm's Solaraze.

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 13, 2013

Greater use of statins in reducing the risk of high cholesterol is among the long-awaited new guidelines for treating lipid and weight disorders.

WASHINGTON — Greater use of statins in reducing the risk of high cholesterol is among the long-awaited new guidelines for treating lipid and weight disorders.

October 22, 2013

The Food and Drug Administration has approved drugs for depression and smoking cessation made by Jubilant Life Sciences, the company said.

NOIDA, India — The Food and Drug Administration has approved drugs for depression and smoking cessation made by Jubilant Life Sciences, the company said.

Jubilant, based in India, announced the approval of generic bupropion hydrochloride extended-release tablets in the 100-mg, 150-mg and 200-mg strengths, and another bupropion hydrochloride extended-release tablet product in the 150-mg strength.

The first product is a generic version of GlaxoSmithKline's antidepressant Wellbutrin SR, while the second is a version of GSK's anti-smoking drug Zyban.

October 21, 2013

The Food and Drug Administration has approved a pain drug made by Iroko Pharmaceuticals, Iroko said.

PHILADELPHIA — The Food and Drug Administration has approved a pain drug made by Iroko Pharmaceuticals, Iroko said.

The drug maker announced the approval of Zorvolex (diclofenac) capsules for mild to moderate acute pain in adults. The drug is a non-steroidal anti-inflammatory drug, or NSAID, belonging to the same class as the common analgesic drug ibuprofen. Zorvolex was approved at dosage strengths 20% lower than currently available diclofenac products, the company said.

October 18, 2013

Chattem recently announced that the Food and Drug Administration approved Nasacort Allergy 24HR nasal spray (triamcinolone intranasal) as an over-the-counter treatment for seasonal and year-round nasal allergies. And that means by spring 2014, there will be another allergy powerhouse alongside Allegra, Claritin and Zyrtec.

Chattem recently announced that the Food and Drug Administration approved Nasacort Allergy 24HR nasal spray (triamcinolone intranasal) as an over-the-counter treatment for seasonal and year-round nasal allergies. And that means by spring 2014, there will be another allergy powerhouse alongside Allegra, Claritin and Zyrtec. 

September 10, 2013

Perrigo announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug application for cetirizine hydrochloride oral solution USP, 1 mg/mL, bubble gum flavored, the store brand equivalent to Children's Zyrtec Allergy Syrup.

ALLEGAN, Mich. — Perrigo on Tuesday announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug application for cetirizine hydrochloride oral solution USP, 1 mg/mL, bubble gum flavored, the store brand equivalent to Children's Zyrtec Allergy Syrup. Perrigo expects to begin shipments of the product during the upcoming cough/cold/flu season.

September 9, 2013

Procter & Gamble is working to eliminate two chemicals — triclosan and diethyl phthalate — from its products by 2014, the manufacturer has stated on its website.

CINCINNATI — Procter & Gamble is working to eliminate two chemicals — triclosan and diethyl phthalate — from its products by 2014, the manufacturer has stated on its website.

According to P&G, triclosan is an antimicrobal ingredient that slows or stops the growth of germs, such as bacteria and mildew. P&G stated that it only uses triclosan in antibacterial dish soap, professional hand soap and a few personal care products.

August 22, 2013

The Food and Drug Administration has approved a supplemental regulatory application from Mylan for a generic antidepressant that was subject last year to scrutiny by the agency amid reports of efficacy problems, Mylan said Thursday.

PITTSBURGH — The Food and Drug Administration has approved a supplemental regulatory application from Mylan for a generic antidepressant that was subject last year to scrutiny by the agency amid reports of efficacy problems, Mylan said Thursday.

The drug maker announced the approval of its supplemental abbreviated new drug application, or sANDA, for bupropion hydrochloride extended-release tablets in the 300-mg strength. The drug is a generic version of GlaxoSmithKline's Wellbutrin XL.

August 20, 2013

The Food and Drug Administration has approved a generic drug for depression made by Par Pharmaceutical, the drug maker said.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a generic drug for depression made by Par Pharmaceutical Cos., the drug maker said Tuesday.

Par announced the approval of bupropion hydrochloride extended-release tablets in the 300-mg strength. The drug is a generic version of GlaxoSmithKline's Wellbutrin XL and is used to treat major depressive disorder. The company already markets the generic drug in the 150-mg strength.

August 13, 2013

Lundbeck announced today that Onfi (clobazam) CIV will be available in scored tablet and oral suspension formulations beginning this week after the formulations were recently approved by the Food and Drug Administration.

DEERFIELD, Ill. — Lundbeck announced today that Onfi (clobazam) CIV will be available in scored tablet and oral suspension formulations beginning this week after the formulations were recently approved by the U.S. Food and Drug Administration. Onfi is a prescription medication originally approved by the FDA in 2011, and is used along with other medicines to treat seizures associated with Lennox-Gastaut syndrome (LGS) in adults and children 2 years of age or older. Onfi is an oral anti-epileptic drug (AED) of the benzodiazepine class, and is a 1,5 benzodiazepine.