Content about Organochlorides

May 17, 2013

Mylan has launched a generic drug for treating cholesterol, the company said.

PITTSBURGH — Mylan has launched a generic drug for treating cholesterol, the company said Friday.

Mylan announced the launch of fenofibrate tablets in the 48 mg and 145 mg strengths. The drug is used to reduce so-called "bad" low-density lipoprotein cholesterol, total cholesterol, triglycerides and apolipoprotein B while increasing "good" high-density lipoprotein cholesterol in adults with primary hyperocholesterolemia or mixed dyslipidemia.

May 6, 2013

FDA approves Bristol-Myers Squibb's Sustiva for HIV in infants, toddlers

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 2, 2013

Bayer HealthCare introduces eight-month flea, tick collar

Bayer HealthCare has introduced a product for controlling fleas and ticks in dogs and cats that lasts eight months, the company's animal health division said Thursday.

SHAWNEE, Kan. — Bayer HealthCare has introduced a product for controlling fleas and ticks in dogs and cats that lasts eight months, the company's animal health division said Thursday.

Seresto is a collar that is designed to provide protection from parasites similar to that provided by monthly topical medications. The collar's active ingredients are flumethrin and imidacloprid, and the company said it kills fleas within 24 hours and ticks within 48 hours after application.

May 1, 2013

Prasco to distribute authorized generic treatment for tumor disorder

Prasco Labs has signed a deal with WellSpring Pharmaceutical Corp. to market an authorized generic version of a drug for a rare tumor disorder.

CINCINNATI — Prasco Labs has signed a deal with WellSpring Pharmaceutical Corp. to market an authorized generic version of a drug for a rare tumor disorder.

The company announced Wednesday the distribution and supply agreement for phenoxybenzamine hydrochloride capsules in the 10 mg strength for pheochromocytoma, an adrenal gland tumor disorder. The drug is used to control episodes of hypertension and sweating associated with the disorder.

April 4, 2013

Covis buys rights to five drugs from Sanofi

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 3, 2013

FDA approves new allergy drug for children

The Food and Drug Administration has approved a new drug for allergies in children made by Tris Pharma, the drug maker said.

MONMOUTH JUNCTION, N.J. — The Food and Drug Administration has approved a new drug for allergies in children made by Tris Pharma, the drug maker said Wednesday.

Tris announced the approval of Karbinal ER (carbinoxamine maleate) extended-release oral suspension in the 4 mg-per-five milliliter strength. The company said the drug was the first sustained-release histamine receptor blocking agent for seasonal and perennial allergic rhinitis in children 2 and older.

March 4, 2013

FDA accepts application for NSAID painkiller

The Food and Drug Administration has accepted a regulatory application for a new painkiller from Iroko Pharmaceuticals, the drug maker said.

PHILADELPHIA — The Food and Drug Administration has accepted a regulatory application for a new painkiller from Iroko Pharmaceuticals, the drug maker said Monday.

Iroko is seeking approval for a lower-dose, submicron diclofenac, a non-steroidal anti-inflammatory drug for treating mild to moderate acute pain in adults.

March 1, 2013

FDA approves Abilify Maintena for schizophrenia

The Food and Drug Administration has approved a once-monthly treatment for schizophrenia.

TOKYO — The Food and Drug Administration has approved a once-monthly treatment for schizophrenia.

Otsuka Pharmaceutical and H. Lundbeck announced the FDA approval of Abilify Maintena (aripiprazole) for extended-release injectable suspension, an intramuscular depot formulation indicated for the treatment of schizophrenia.

The companies described Abilify Maintena as the first dopamine D2 partial agonist approved as a once-monthly injection, contributing to a new treatment option to address the ongoing need for relapse prevention in patients with schizophrenia.

February 25, 2013

Mylan ships cholesterol drug

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 15, 2013

FDA seizes tainted product from Florida's Globe All Wellness

U.S. marshals, acting on behalf of the Food and Drug Administration, on Thursday seized tainted products from Globe All Wellness in Hollywood, Fla.

SILVER SPRING, Md. — U.S. marshals, acting on behalf of the Food and Drug Administration, on Thursday seized tainted products from Globe All Wellness in Hollywood, Fla. The products may be unsafe because they contain an undisclosed active pharmaceutical ingredient.

February 14, 2013

United Therapeutics resubmits application for pulmonary arterial hypertension drug

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.

January 25, 2013

Dr. Reddy's launches allergy drug

Dr. Reddy's has launched a drug used for treating allergies, the generic drug maker said Friday.

HYDERABAD, India — Dr. Reddy's Labs has launched a drug used for treating allergies, the generic drug maker said Friday.

The Indian drug maker announced the launch of desloratadine orally disintegrating tablets in the 2.5-mg and 5-mg strengths. The drug is a generic version of Merck's Clarinex Reditabs and is available in unit-dose packages of 30.

The branded version of the drug had sales of about $5.3 million during the 12-month period that ended in November 2012, according to IMS Health.

January 10, 2013

FDA approves Wockhardt epilepsy drug

The Food and Drug Administration has approved a generic epilepsy drug made by Wockhardt, the company said.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic epilepsy drug made by Wockhardt, the company said.

Wockhardt, based in India, announced the approval of lamotrigine extended-release tablets in the 25-mg, 50-mg, 100-mg, 200-mg and 300-mg strengths.

The drug is a generic version of GlaxoSmithKline's Lamictal XR. The U.S. market for the drug is about $250 million, according to IMS Health.

January 10, 2013

FDA calls for lower dosage in some insomnia drugs

The Food and Drug Administration is ordering the makers of several sleep drugs to lower the dosage due to the risk that they can impair patients the morning after, the agency said Thursday.

SILVER SPRING, Md. — The Food and Drug Administration is ordering the makers of several sleep drugs to lower the recommended dosage due to the risk that they can impair patients the morning after, the agency said Thursday.

The FDA announced that it was requiring the manufacturers of drugs containing the active ingredient zolpidem to lower the current recommended dosage in light of new data showing that the morning after use, the drug can remain in the blood in sufficient quantities to impair activities that require alertness, such as driving.

January 8, 2013

FDA advises consumers not to purchase adulterated 'MAXILOSS Weight Advanced'

The Food and Drug Administration on Tuesday advised consumers not to purchase or use “MAXILOSS Weight Advanced” — a product promoted and sold for weight loss on various web sites, including DreamLifeWeightLoss.com, and in some retail stores.

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday advised consumers not to purchase or use “MAXILOSS Weight Advanced” — a product promoted and sold for weight loss on various web sites, including DreamLifeWeightLoss.com, and in some retail stores.

December 28, 2012

Perrigo acquires remaining stake in Cobrek Pharmaceuticals

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.

November 29, 2012

Record patent expirations roil Rx market

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 27, 2012

Wockhardt receives three FDA approvals

Indian generic drug maker Wockhardt received three new drug approvals from the Food and Drug Administration, agency records show.

SILVER SPRING, Md. — Indian generic drug maker Wockhardt received three new drug approvals from the Food and Drug Administration, agency records show.

November 21, 2012

Lupin launches generic fenofibrate

Lupin Pharmaceuticals has launched a generic drug for cholesterol disorders, the company said.

BALTIMORE — Lupin Pharmaceuticals has launched a generic drug for cholesterol disorders, the company said.

Lupin announced the launch of fenofibrate tablets in the 48-mg and 145-mg strengths. The drug is used to treat hypercholesterolemia or mixed dyslipidemia and severe hypertriglyceridemia.

The drug is a generic version of Abbott's Tricor, which had sales of $1.26 billion during the 12-month period ended in June, according to IMS Health.

October 22, 2012

Watson, Actavis divest more drugs as condition for FTC merger approval

Watson Pharmaceuticals and Actavis will have to divest rights to almost two dozen drugs as a condition for U.S. regulatory approval of their $5.6 billion merger announced earlier this year, according to regulatory documents.

NEW YORK – Watson Pharmaceuticals and Actavis will have to divest rights to almost two dozen drugs as a condition for U.S. regulatory approval of their $5.6 billion merger announced earlier this year, according to regulatory documents.

October 5, 2012

FDA issues new guidelines for budeprion XL in the 300-mg strength

The Food and Drug Administration has reviewed new data that indicated that budeprion XL (bupropion hydrochloride extended-release tablets) in the 300-mg strength, manufactured by Impax Labs and Teva Pharmaceuticals USA, is not therapeutically equivalent to Wellbutrin XL in the 300-mg strength.

WASHINGTON — The Food and Drug Administration has reviewed new data that indicated that budeprion XL (bupropion hydrochloride extended-release tablets) in the 300-mg strength, manufactured by Impax Labs and Teva Pharmaceuticals USA, is not therapeutically equivalent to Wellbutrin XL in the 300-mg strength.

September 28, 2012

Bi-Lo adds generic Plavix to discount program

Supermarket chain Bi-Lo is adding the generic form of a blood-thinning drug to its generic-discount program.

JACKSONVILLE, Fla. — Supermarket chain Bi-Lo is adding the generic form of a blood-thinning drug to its generic-discount program.

The company announced Friday that patients could buy generic clopidogrel for $4 for a 30-day supply and $10 for a 90-day supply with the chain's Pharmacy Discount Card. The branded version of the drug, which recently became available as a generic, is marketed by Sanofi and Bristol-Myers Squibb.

September 21, 2012

FDA approves Mylan motion sickness drug

The Food and Drug Administration has approved a generic drug for motion sickness made by Mylan.

PITTSBURGH — The Food and Drug Administration has approved a generic drug for motion sickness made by Mylan.

The drug maker announced Friday that the FDA had approved meclizine hydrochloride tablets in the 12.5-mg, 25-mg and 50-mg strengths. Mylan said it would launch the drug immediately.

The drug is a generic version of Pfizer's Antivert, which is used to treat nausea, vomiting and dizziness associated with motion sickness. Antivert had sales of about $53.5 million during the 12-month period ended in June, according to IMS Health.

September 18, 2012

PDUFA, GDUFA make 2012 milestone year

2012 is turning out to be a pretty important year for generic drugs, important enough that some of the things happening over the past several months have begged comparison to 1984, probably the biggest milestone year for the industry. 

September 4, 2012

FDA approves Wockhardt antidepressant

The Food and Drug Administration has approved a generic antidepressant made by Wockhardt, the Indian drug maker said Tuesday.

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

Wockhardt announced the FDA approval of its bupropion hydrochloride extended-release tablets in the 100 mg, 150 mg and 200 mg strengths.

The drug is a generic version of GlaxoSmithKline's Wellbutrin SR, various versions of which have a market of about $268 million, according to IMS Health.