Content about Generics

January 17, 2012

The main lobby representing pharmacy benefit managers is launching an advertising campaign amid scrutiny the industry has received lately from the public and lawmakers.

WASHINGTON — The main lobby representing pharmacy benefit managers is launching an advertising campaign amid scrutiny the industry has received lately from the public and lawmakers.

The Pharmaceutical Care Management Association announced Tuesday the launch of its new "That's What PBMs Do" ad campaign, which includes print and video ads that focus on what the PCMA called PBMs' role in reducing pharmacy costs, Medicare Part D and mail-order pharmacy.

January 17, 2012

A committee formed by Taro Pharmaceutical Industries in December is continuing to evaluate an acquisition offer by India-based Sun Pharmaceutical Industries, Taro said.

HAIFA BAY, Israel — A committee formed by Taro Pharmaceutical Industries in December is continuing to evaluate an acquisition offer by India-based Sun Pharmaceutical Industries, Taro said.

Sun is hoping to acquire Israel-based Taro for $24.50 per share.

The committee, comprising members of the company's board of directors, has brought on Citigroup Global Markets as its financial adviser and is receiving legal advice from Israeli legal firm Goldfarb Seligman & Co. and U.S. firm Willkie Farr & Gallagher.

January 16, 2012

The Food and Drug Administration's latest message to consumers and healthcare professionals seems like a no-brainer: "Insulin pens are not for sharing."

SILVER SPRING, Md. — The Food and Drug Administration's latest message to consumers and healthcare professionals seems like a no-brainer: "Insulin pens are not for sharing."

But the agency said it knew of two undisclosed hospitals that it said had reused the cartridge components of insulin pens in administering insulin to more than 2,000 patients, though the hospitals reportedly changed the pens themselves.

January 16, 2012

The Food and Drug Administration has finished and sent to Congress its recommendations for a proposed Generic Drug User Fee Act, drawing praise from the generic drug industry.

WASHINGTON — The Food and Drug Administration has finished and sent to Congress its recommendations for a proposed Generic Drug User Fee Act, drawing praise from the generic drug industry.

GDUFA calls for the generic industry to pay $299 million per year for five years, in addition to what Congress gives the FDA. The money would come in the form of user fees for companies that submit regulatory approval applications to the agency for review.

January 12, 2012

Prasco Labs will act as the distributor for an authorized generic version of a Shire anticonvulsant drug, the company said Thursday.

CINCINNATI — Prasco Labs will act as the distributor for an authorized generic version of a Shire anticonvulsant drug, the company said Thursday.

Prasco announced that it had partnered with Shire to distribute carbamazepine extended-release capsules in the 100-mg, 200-mg and 300-mg strengths. The drug is an authorized generic version of Carbatrol, used to treat certain types of seizures and pain.

Authorized generics are branded drugs sold under their generic names at a reduced price.

January 10, 2012

Generic drug maker Hospira has enrolled the first patient in a late-stage clinical trial of a biosimilar drug for treating kidney disease.

LAKE FOREST, Ill. — Generic drug maker Hospira has enrolled the first patient in a late-stage clinical trial of a biosimilar drug for treating kidney disease.

The company said the phase-3 trial of biosimilar EPO (erythropoietin) would compare its product with Amgen's Epogen in patients with kidney dysfunction who have anemia. The trial, which will enroll about 1,000 patients who already have taken Epogen, follows a phase-1 trial that ended last year, and results of the late-stage trial are expected next year.

January 9, 2012

Generic drug maker Mylan is challenging the patent on a drug used to treat diabetes, the company said Monday.

PITTSBURGH — Generic drug maker Mylan is challenging the patent on a drug used to treat diabetes, the company said Monday.

Mylan said that it was sued by Takeda Pharmaceutical, Watson Pharmaceuticals and Andrx Labs in the U.S. District Court for the Southern District of New York in response to Mylan's filing a regulatory approval application with the Food and Drug Administration for a generic version of Actoplus Met XR (pioglitazone hydrochloride and metformin hydrochloride) extended-release tablets in the 15-mg/1,000-mg and 30-mg/1,000-mg strengths.

January 9, 2012

Drug maker Perrigo is buying a privately owned distributor of diabetes products, the company said Monday.

ALLEGAN, Mich. — Drug maker Perrigo is buying a privately owned distributor of diabetes products, the company said Monday.

Perrigo announced the $36 million acquisition of Alpharetta, Ga.-based CanAm Care, whose assets include Dex4 hypoglycemia products, insulin delivery syringes and pen needles, lancing, wound care and compression stockings.

January 6, 2012

Sandoz has launched a shampoo used to treat severe scalp psoriasis, the generic drug maker said.

PRINCETON, N.J. — Sandoz has launched a shampoo used to treat severe scalp psoriasis, the generic drug maker said.

Sandoz announced the introduction of clobetasol propionate shampoo in the 0.05% strength, an authorized generic version of Galderma Labs' Clobex. An authorized generic drug is a branded drug sold under its generic name, usually by a third-party company at a reduced price.

Various versions of the shampoo had sales of about $54.9 million during the 12-month period ended in October 2011, according to IMS Health.

 

January 4, 2012

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

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

January 4, 2012

Perrigo last week announced that it has received final Food and Drug Administration approval for its generic prescription allergy remedy desloratadine 5 mg, the generic equivalent to Schering-Plough's Clarinex.

ALLEGAN, Mich. — Perrigo last week announced that it has received final Food and Drug Administration approval for its generic prescription allergy remedy desloratadine 5 mg, the generic equivalent to Schering-Plough's Clarinex.

Under the terms of a patent-infringement suit settlement, Perrigo can commercially launch its generic desloratadine product July 1. The new product launch may be a prescription or over-the-counter product, depending on its status at the time of launch, Perrigo stated.

January 3, 2012

Actavis has begun shipping clobetasol propionate shampoo and clobetasol propionate lotion, which were granted 180-day marketing exclusivity by the Food and Drug Administration.

MORRISTOWN, N.J. — Actavis has begun shipping clobetasol propionate shampoo and clobetasol propionate lotion, which were granted 180-day marketing exclusivity by the Food and Drug Administration.

The shampoo and topical lotion are generic equivalents of Galderma's Clobex shampoo and Clobex topical lotion, which have garnered sales of $89.9 million for the 12 months ended in September 2011.

January 3, 2012

The Food and Drug Administration has approved a drug for epilepsy made by Mylan, the drug maker said.

PITTSBURGH — The Food and Drug Administration has approved a drug for epilepsy made by Mylan, the drug maker said.

The FDA approved Mylan's levetiracetam extended-release tablets in the 500-mg and 750-mg strengths.

The drug is a generic version of UCB's Keppra XR, used to treat partial onset seizures in epilepsy patients ages 16 years and older.

Various versions of the drug had sales of about $162.8 million during the 12-month period ended in September, according to IMS Health.

January 3, 2012

Mylan has launched a generic drug for treating high blood pressure, the company said.

PITTSBURGH — Mylan has launched a generic drug for treating high blood pressure, the company said.

The drug maker announced the launch of eprosartan mesylate tablets in the 400-mg and 600-mg strengths. The drug is a generic version of Abbott's Teveten and is used to treat hypertension.

January 3, 2012

While physicians and pharmacists alike generally view electronic prescribing with favor, several barriers stand in the way of their realizing its full benefit, according to a November government study.


While physicians and pharmacists alike generally view electronic prescribing with favor, several barriers stand in the way of their realizing its full benefit, according to a November government study.


January 3, 2012

Pharmacy technology provider PDX is partnering with Mscripts to allow existing PDX Classic and Enterprise Pharmacy System customers to add mobile to their customer-facing offerings, the companies said.

SUPPLIER NEWS — Pharmacy technology provider PDX is partnering with Mscripts to allow existing PDX Classic and Enterprise Pharmacy System customers to add mobile to their customer-facing offerings, the companies said. The features will give pharmacies an outreach channel to improve their bin management and will-call services, as well as allow them to easily identify aging prescriptions and use the Mscripts mobile application to remind customers to pick up their prescriptions.


January 3, 2012

The role of the pharmacist has evolved considerably over the past decade, and few things exemplify that evolution more than pharmacists taking an active role in patients’ medication therapies and consulting with them one-on-one.


The role of the pharmacist has evolved considerably over the past decade, and few things exemplify that evolution more than pharmacists taking an active role in patients’ medication therapies and consulting with them one-on-one.


January 3, 2012

Teva Pharmaceutical Industries announced that Shlomo Yanai, president and CEO, will retire from his post in May.

JERUSALEM — Teva Pharmaceutical Industries announced that Shlomo Yanai, president and CEO, will retire from his post in May.

Yanai, who has served in this capacity for five years, has helped Teva expand from a mainly generics business to a more diversified pharmaceutical company, with expected 2012 revenue of approximately $22 billion, and an expanded footprint in the European, Asian and Latin America markets.

December 23, 2011

Baxter and Momenta have agreed to partner to develop and market biosimilar drugs to treat cancer, autoimmune disorders and other chronic conditions.

NEW YORK — Baxter and Momenta have agreed to partner to develop and market biosimilar  drugs to treat cancer, autoimmune disorders and other chronic conditions.

December 23, 2011

Drug makers will focus on patient-specific therapies instead of drugs designed for use by a broad range of people over the next decade, according to a new report released Thursday by Thomson Reuters.

PHILADELPHIA — Drug makers will focus on patient-specific therapies instead of drugs designed for use by a broad range of people over the next decade, according to a new report released Thursday by Thomson Reuters.

The report, titled "The Changing Role of Chemistry in Drug Discovery" and based on drug industry productivity, patent data and other dynamics and trends, was released in recognition of the International Year of Chemistry 2011.

December 22, 2011

Drug maker Actavis is partnering with QRxPharma to sell what the former called a novel pain drug in the United States.

MORRISTOWN, N.J. — Drug maker Actavis is partnering with QRxPharma to sell what the former called a novel pain drug in the United States.

The company said Wednesday that the two had signed a letter of intent to commercialize MoxDuo IR (morphine and oxycodone), which they plan to launch in third quarter 2012.

December 22, 2011

Amneal Pharmaceuticals has launched its generic version of a drug designed to treat seizures in adults and children with epilepsy.

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has launched its generic version of a drug designed to treat seizures in adults and children with epilepsy.

The generic drug maker said it received approval from the Food and Drug Administration on Dec. 16 for felbamate oral suspension in the 600-mg/5-mL strength. The Amneal generic is available in two sizes, 8 fl. oz./240 mL and 16 fl. oz./473 mL. It is a generic version of Meda Pharmaceuticals' antiepileptic Felbatol.

December 21, 2011

Ranbaxy Labs said Wednesday that it had resolved long-standing issues concerning two of its manufacturing plants in India with the U.S. government.

GURGAON, India — Ranbaxy Labs said Wednesday that it had resolved long-standing issues concerning two of its manufacturing plants in India with the U.S. government.

December 20, 2011

Upsher-Smith has launched an online portal for advanced-practice clinicians interested in women's health, the company said.

MAPLE GROVE, Minn. — Upsher-Smith has launched an online portal for advanced-practice clinicians interested in women's health, the company said.

Clinicians Corner provides nurse practitioners, physician assistants, nurses and midwives with resources and educational materials.

December 20, 2011

Generic drug maker Watson and biotech manufacturer Amgen will work together to develop biosimilar antibodies for treating cancer, the two companies said.

PARSIPPANY, N.J. — Generic drug maker Watson and biotech manufacturer Amgen will work together to develop biosimilar antibodies for treating cancer, the two companies said.