Content about Generic drug

July 7, 2011

Preventive health care may be signficiantly less costly than previously thought because of the expanded use of cost-effective generic medications for the treatment and prevention of chronic diseases, according to researchers from Harvard University, Brigham and Women's Hospital and CVS Caremark.

WOONSOCKET, R.I. — Preventive health care may be signficiantly less costly than previously thought because of the expanded use of cost-effective generic medications for the treatment and prevention of chronic diseases, according to researchers from Harvard University, Brigham and Women's Hospital and CVS Caremark.

July 7, 2011

Generic drug maker Hi-Tech Pharmacal reported its fourth-quarter net sales increased 45% to $57.2 million from the year-ago period.

AMITYVILLE, N.Y. — Generic drug maker Hi-Tech Pharmacal reported its fourth-quarter net sales increased 45% to $57.2 million from the year-ago period.

Net income for Hi-Tech totaled $12.7 million, or 98 cents per diluted share, compared with $6.5 million, or 50 cents per diluted share in fourth quarter 2010.

July 7, 2011

The Food and Drug Administration has approved an additional strength of a generic drug made by Lupin Pharmaceuticals for high blood pressure, Lupin said Wednesday.

BALTIMORE — The Food and Drug Administration has approved an additional strength of a generic drug made by Lupin Pharmaceuticals for high blood pressure, Lupin said Wednesday.

Lupin announced the approval of amlodipine besylate and benazepril hydrochloride capsules in the 5-mg/40-mg and 10-mg/40-mg strengths. The company already markets the drug in the 2.5-mg/10-mg, 5-mg/10-mg, 5-mg/20-mg and 10-mg/20-mg strengths.

July 5, 2011

Shire has filed patent infringement suits against two generic drug makers relating to its attention deficit hyperactivity disorder treatment.

DUBLIN — Shire has filed patent infringement suits against two generic drug makers relating to its attention deficit hyperactivity disorder treatment.

Shire said it has filed lawsuits in the U.S. District Court for the District of New Jersey against Amneal Pharmaceuticals and Sandoz. Amneal and Sandoz recently filed abbreviated new drug applications with the Food and Drug Administration to market generic Vyvanse (lisdexamfetamine), an ADHD drug.

June 28, 2011

Generic drug maker Hi-Tech Pharmacal said that it has acquired marketing and distribution rights to pain treatments made by Atley Pharmaceuticals.

AMITYVILLE, N.Y. — Generic drug maker Hi-Tech Pharmacal said that it has acquired marketing and distribution rights to pain treatments made by Atley Pharmaceuticals.

Hi-Tech, which paid $3.6 million in cash for rights to the products and inventory, said some of Atley's drugs already have been approved by the Food and Drug Administration, while others were pending approval. The company didn't say which products it was acquiring the rights to, but noted that Hi-Tech subsidiary ECR Pharmaceuticals will produce and promote the products.

June 27, 2011

Prices for the top 10 most prescribed branded diabetes drugs have risen faster at Walmart and Kmart than at other retailers, according to a published report.

NEW YORK — Prices for the top 10 most prescribed branded diabetes drugs have risen faster at Walmart and Kmart than at other retailers, according to a published report.

Citing a recent study by researchers at the Mount Sinai Medical Center in New York, Reuters reported that Walmart raised prices for branded diabetes drugs by 32% between 2008 and 2010, compared with 21% for the industry as a whole — including independent and chain retail pharmacies and mail-order companies. Kmart raised prices by 35%.

June 27, 2011

The law targeting data mining in Vermont, along with laws in New Hampshire and Maine, would have forced drug companies to significantly change the way they market drugs to physicians had the Supreme Court allowed them to stand in the case of Sorrell, Attorney General of Vermont, et al. vs. IMS Health Inc., et al.

WHAT IT MEANS AND WHY IT'S IMPORTANT — The law targeting data mining in Vermont, along with laws in New Hampshire and Maine, would have forced drug companies to significantly change the way they market drugs to physicians had the Supreme Court allowed them to stand in the case of Sorrell, Attorney General of Vermont, et al. vs. IMS Health Inc., et al.

(THE NEWS: Supreme Court strikes down Rx data mining law. For the full story, click here.)

June 22, 2011

Generic drug maker Dr. Reddy’s Labs has launched its version of a popular antibiotic.

HYDERABAD, India — Generic drug maker Dr. Reddy’s Labs has launched its version of a popular antibiotic.

The company said its levofloxacin tablets in the 250-mg, 500-mg and 750-mg strengths have entered the market, following the Food and Drug Administration's approval of Dr. Reddy's abbreviated new drug application. Dr. Reddy's levofloxacin tablets in the 250-mg and 500-mg strengths are available in 50-count bottles, while the 750-mg strength bottle is available in 30-count bottles.

June 21, 2011

Watson subsidiary Watson Labs is seeking approval for a drug designed to treat symptomatic benign prostatic hyperplasia in men with an enlarged prostate.

PARSIPPANY, N.J. — Watson subsidiary Watson Labs is seeking approval for a drug designed to treat symptomatic benign prostatic hyperplasia in men with an enlarged prostate.

The company filed an abbreviated new drug application to market dutasteride capsules in the 0.5-mg strength. The drug is a generic version of Avodart, which is made by GlaxoSmithKline.

June 20, 2011

The latest drug trend report from pharmacy benefit manager Express Scripts estimated that if patients using maintenance medications used cheaper therapies when possible, adhered to their medication therapies and used home delivery, it could eliminate $403 billion in pharmacy waste every year.


June 20, 2011

Mylan has scored a victory in its efforts to make a generic version of a Teva drug for multiple sclerosis.

PITTSBURGH — Mylan has scored a victory in its efforts to make a generic version of a Teva drug for multiple sclerosis.

The U.S. District Court for the Southern District of New York denied Teva’s motion for a summary judgment finding no inequitable conduct in relation to Copaxone (glatiramer acetate).

June 15, 2011

Teva Pharmaceutical Industries has begun shipping a generic drug for allergies, partnering company Perrigo said Wednesday.

ALLEGAN, Mich. — Teva Pharmaceutical Industries has begun shipping a generic drug for allergies, partnering company Perrigo said Wednesday.

Triamcinolone acetonide nasal spray is a generic version of Sanofi’s Nasacort AQ and is used to treat nasal symptoms of seasonal and year-round allergies in patients ages 6 years and older. The Food and Drug Administration approved the generic version of the drug in 2009. The generic was made by Barr Labs, which Teva acquired a few years ago.

June 15, 2011

Watson Pharmaceuticals has filed a regulatory approval application with the Food and Drug Administration for a generic drug for eye disease, the company said Tuesday.

PARSIPPANY, N.J. — Watson Pharmaceuticals has filed a regulatory approval application with the Food and Drug Administration for a generic drug for eye disease, the company said Tuesday.

Watson is seeking approval for olopatadine hydrochloride ophthalmic solution in the 0.2% strength. The drug, used to treat itching in the eye resulting from allergic conjunctivitis, is a generic version of Alcon’s Pataday.

June 14, 2011

Before they can move ahead with their deal, drug makers Teva and Cephalon must provide the Federal Trade Commission with additional information related to Teva's pending acquisition of Cephalon.

JERUSALEM and FRAZER, Pa. — Before they can move ahead with their deal, drug makers Teva and Cephalon must provide the Federal Trade Commission with additional information related to Teva's pending acquisition of Cephalon.

June 7, 2011

The Food and Drug Administration has given final approval to a generic drug for insomnia made by Actavis, the drug maker said Monday.

MORRISTOWN, N.J. — The Food and Drug Administration has given final approval to a generic drug for insomnia made by Actavis, the drug maker said Monday.

The FDA approved the company’s zolpidem tartrate extended-release tablets in the 12.5-mg strength. The drug, which is a Schedule IV controlled substance, is a generic version of Sanofi’s Ambien CR. Actavis was the first company to launch a generic version of the drug in the 6.25-mg strength in October 2010.

June 7, 2011

Another generic drug maker has been given the green light to market its version of an Alzheimer's disease treatment.

PITTSBURGH — Another generic drug maker has been given the green light to market its version of an Alzheimer's disease treatment.

Mylan said that its subsidiary, Matrix Labs, has received final approval from the Food and Drug Administration to manufacture and market donepezil hydrochloride tablets in 5-mg and 10-mg strengths. The drug, a generic version of Pfizer and Eisai's Aricept, is used to treat dementia associated with Alzheimer's disease. Mylan said it will launch the product immediately.

June 6, 2011

The Food and Drug Administration has found manufacturing issues at a plant owned by generic drug maker Impax Labs, the drug maker said Monday.

HAYWARD, Calif. — The Food and Drug Administration has found manufacturing issues at a plant owned by generic drug maker Impax Labs, the drug maker said Monday.

June 3, 2011

Pfizer has filed suit against generic drug maker Impax Labs in connection with the latter’s attempt to market a generic drug for bladder problems.

HAYWARD, Calif. — Pfizer has filed suit against generic drug maker Impax Labs in connection with the latter’s attempt to market a generic drug for bladder problems.

Impax said Friday that Pfizer filed a patent infringement suit in the U.S. District Court of the District of New Jersey in connection with Impax’s attempt to market a generic version of Detrol (tolterodine tartrate) immediate-release tablets in the 1-mg and 2-mg strengths. The drug is used to treat overactive bladder and urinary incontinence.

June 2, 2011

The Food and Drug Administration has approved a generic drug for Alzheimer’s disease made by Teva Pharmaceutical Industries.

JERUSALEM — The Food and Drug Administration has approved a generic drug for Alzheimer’s disease made by Teva Pharmaceutical Industries.

The FDA approved Teva’s donepezil hydrochloride tablets in the 5-mg and 10-mg strengths.

The drug is a generic version of Aricept, made by Pfizer and Eisai. Branded and generic versions of the drug had sales of about $2.3 billion during the 12-month period ended in March, according to IMS Health.

May 23, 2011

A generic drug maker has been granted approval from the Food and Drug Administration to manufacture its version of a urinary tract infection treatment.

BRIDGEWATER, N.J. — A generic drug maker has been granted approval from the Food and Drug Administration to manufacture its version of a urinary tract infection treatment.

Amneal Pharmaceuticals said that its nitrofurantoin oral suspension in the 25-mg/5-mL strength is the first-to-market, AB-rated, generic version of Furadantin, which is made by Shionogi Pharma.

Amneal will sell its generic in 8-oz./230-mL size bottles, the company said.

May 23, 2011

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

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

Mylan said Monday that the FDA had approved its divalproex sodium capsules in the 125-mg strength. The drug is a generic version of Abbott’s Depakote Sprinkle capsules and is used to treat certain types of epileptic seizures.

Divalproex sodium capsules had sales of about $89 million during the 12-month period ended in March, according to IMS Health.

May 23, 2011

Generic drug maker Par has inked a definitive agreement to acquire an India-based developer and manufacturer of generic drugs.

WOODCLIFF LAKE, N.J. — Generic drug maker Par has inked a definitive agreement to acquire an India-based developer and manufacturer of generic drugs.

Par said it will acquire Edict Pharmaceuticals for up to $37.6 million in cash and Par's repayment of certain additional pre-close indebtedness. Par noted the acquisition is subject to customary conditions and approvals; the drug maker expects to complete the transaction by the end of the year.

May 23, 2011

The FDA has approved a new treatment for Type 2 diabetes, the agency said. The FDA announced the approval of Tradjenta (linagliptin) made by Indianapolis-based Eli Lilly and German drug maker Boehringer Ingelheim.


SUPPLIER NEWS — The FDA has approved a new treatment for Type 2 diabetes, the agency said. The FDA announced the approval of Tradjenta (linagliptin) made by Indianapolis-based Eli Lilly and German drug maker Boehringer Ingelheim.


May 20, 2011

Sandoz is looking to market a generic version of a Shire drug for treating attention deficit hyperactivity disorder.

DUBLIN — Sandoz is looking to market a generic version of a Shire drug for treating attention deficit hyperactivity disorder.

May 17, 2011

A court in France has ordered generic drug maker Mylan to pay French drug maker Ipsen $24 million for allegedly misleading marketing of a drug, according to published reports.

PARIS — A court in France has ordered generic drug maker Mylan to pay French drug maker Ipsen $24 million for allegedly misleading marketing of a drug, according to published reports.

Bloomberg reported that Mylan had allegedly marketed the drug Vitalogink as a generic version of Ipsen’s Tanakan rather than as a “therapeutic equivalent.” Both drugs are derived from ginkgo biloba and are used to improve memory.

Mylan has said it will appeal the decision, Bloomberg reported.