Content about Clinical research

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.

August 30, 2012
FDA approves Teva biosimilar

The Food and Drug Administration has approved a biosimilar drug made by Teva Pharmaceutical Industries for a condition that results from certain chemotherapy treatments, the drug maker said Thursday.

JERUSALEM — The Food and Drug Administration has approved a biosimilar drug made by Teva Pharmaceutical Industries for a condition that results from certain chemotherapy treatments, the drug maker said Thursday.

August 28, 2012
Sun Pharma's Caraco gets FDA OK to resume operations

The Food and Drug Administration has determined that generic drug maker Caraco is in compliance with relevant paragraphs of the consent decree and may resume operations at its manufacturing facility and packaging sites in Detriot and Wixom, Mich., Caraco's parent company Sun Pharmaceutical Industries said.

MUMBAI, India — The Food and Drug Administration has determined that generic drug maker Caraco is in compliance with relevant paragraphs of the consent decree and may resume operations at its manufacturing facility and packaging sites in Detriot and Wixom, Mich., Caraco's parent company Sun Pharmaceutical Industries said.

During their inspection, the FDA reviewed the certification reports for heart failure treatment Carvedilol USP, as well as antibiotic Paramomycin USP, and determined Caraco may resume production of only these two drugs.

August 27, 2012
Genzyme provides update on Lemtrada filing with FDA

Genzyme announced it has received a refuse-to-file letter from the Food and Drug Administration in response to the drug maker's supplemental biologics license application for the approval of Lemtrada (alemtuzumab) as a treatment for relapsing multiple sclerosis.

CAMBRIDGE, Mass. — Genzyme announced it has received a refuse-to-file letter from the Food and Drug Administration in response to the drug maker's supplemental biologics license application for the approval of Lemtrada (alemtuzumab) as a treatment for relapsing multiple sclerosis.

August 24, 2012
FDA approves Watson pain patch

The Food and Drug Administration has approved a generic medicated patch for treating pain made by Watson Pharmaceuticals, the company said.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic medicated patch for treating pain made by Watson Pharmaceuticals, the company said.

Watson announced the approval of lidocaine topical patch in the 5% strength. The drug is a generic version of Endo Pharmaceuticals' Lidoderm, which had sales of about $1.2 billion during the 12-month period ended in June 2012, according to IMS Health.

August 23, 2012
AcelRx starts third phase-3 trial of drug for post-operative pain

A drug maker that specializes in pain medications started the third late-stage trial of a drug for treating pain in patients who have undergone certain surgeries.

REDWOOD CITY, Calif. — A drug maker that specializes in pain medications started the third late-stage trial of a drug for treating pain in patients who have undergone certain surgeries.

August 23, 2012
FDA approves Wockhardt hypertension drug

The Food and Drug Administration has approved a generic drug for high blood pressure made by Wockhardt, the Indian drug maker said.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic drug for high blood pressure made by Wockhardt, the Indian drug maker said.

Wockhardt announced the approval of felodipine extended-release tablets in the 2.5 mg, 5 mg and 10 mg strengths. The drug is a generic version of AstraZeneca's Plendil, and Wockhardt said it would launch the drug immediately.

Various versions of the drug have a market presence of more than $66 million, according to IMS Health.

August 23, 2012
FDA gives Wockhardt tentative approval for bipolar, schizophrenia drug

Indian drug maker Wockhardt has received tentative approval from the Food and Drug Administration for a generic version of a Pfizer psychiatric drug.

PARSIPPANY, N.J. — Indian drug maker Wockhardt has received tentative approval from the Food and Drug Administration for a generic version of a Pfizer psychiatric drug.

Wockhardt announced the tentative approval for ziprasidone hydrochloride in the 20 mg, 40 mg, 60 mg and 80 mg strengths, used to treat bipolar disorder and schizophrenia, and the company plans to launch the drug on Sept. 2, 2012.

August 9, 2012
Hospira relaunches chemotherapy drug

Hospira has relaunched a generic chemotherapy drug for the U.S. market, the generic drug maker said Thursday.

LAKE FOREST, Ill. — Hospira has relaunched a generic chemotherapy drug for the U.S. market, the generic drug maker said Thursday.

The company, which specializes in generic injectables, announced the relaunch of oxaliplatin, a version of Sanofi's Eloxatin.

August 9, 2012
Sagent Pharmaceuticals launches oxaliplatin

Drug maker Sagent Pharmaceuticals has launched a generic chemotherapy drug, the company said Thursday.

SCHAUMBURG, Ill. — Drug maker Sagent Pharmaceuticals has launched a generic chemotherapy drug, the company said Thursday.

Sagent announced the launch of oxaliplatin, a generic version of Sanofi's Eloxatin.

Various versions of the drug had sales of about $1.7 billion during the 12-month period ended in June, according to IMS Health.

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August 8, 2012
Teva, Active Biotech plan third MS drug trial

Drug makers Teva Pharmaceutical Industries and Active Biotech will start a third late-stage clinical trial of an experimental drug for treating multiple sclerosis, the companies said Wednesday.

JERUSALEM — Drug makers Teva Pharmaceutical Industries and Active Biotech will start a third late-stage clinical trial of an experimental drug for treating multiple sclerosis, the companies said Wednesday.

Israel-based Teva and Sweden-based Active Biotech said they would start a phase-3 trial of laquinimod for relapsing-remitting multiple sclerosis, also known as RRMS, following an agreement with the Food and Drug Administration.

August 6, 2012
Amneal plans $120 million expansion

Generic drug maker Amneal Pharmaceuticals will spend $120 million to expand three of its plants, the company said Monday.

BRIDGEWATER, N.J. — Generic drug maker Amneal Pharmaceuticals will spend $120 million to expand three of its plants, the company said Monday.

Amneal said it would spend the money over a two-year period lasting through 2014 to "significantly" grow operations at research-and-development, manufacturing and distribution plants in New York, New Jersey and Kentucky. The company, which employs more than 1,100 people in the United States, said the expansion would create 500 more jobs.

August 2, 2012
Generics saved $1 trillion over last 10 years, study finds

Use of generic drugs has saved consumers and the healthcare system $1 trillion over the past decade, according to a new study released Thursday by a generic drug industry trade organization.

WASHINGTON — Use of generic drugs has saved consumers and the healthcare system $1 trillion over the past decade, according to a new study released Thursday by a generic drug industry trade organization.

The Generic Pharmaceutical Association said that between 2002 and 2011, generics saved the country $1 billion every other day, totaling $193 billion in 2011.

July 31, 2012
AmerisourceBergen books $18 billion-plus in Express Scripts business

AmerisourceBergen on Tuesday announced that it has signed a three-year agreement to supply approximately $18.5 billion in pharmaceuticals to Express Scripts on an annual basis.

VALLEY FORGE, Pa. — AmerisourceBergen on Tuesday announced that it has signed a three-year agreement to supply approximately $18.5 billion in pharmaceuticals to Express Scripts on an annual basis. The agreement is effective Oct. 1.

“We are honored that Express Scripts has chosen AmerisourceBergen to supply the brand pharmaceuticals it needs for its recently combined mail-order and specialty pharmacy business,” said Steven Collis, AmerisourceBergen president and CEO.

July 30, 2012
Takeda resubmits diabetes drug applications

Drug maker Takeda Pharmaceutical has resubmitted regulatory approval applications for two drugs designed to treat diabetes, the company said.

DEERFIELD, Ill. — Drug maker Takeda Pharmaceutical has resubmitted regulatory approval applications for two drugs designed to treat diabetes, the company said.

Takeda announced the resubmission to the Food and Drug Administration of applications for alogliptin and a drug that combines alogliptin with pioglitazone, the active ingredient in the Takeda drug Actos.

July 18, 2012
FDA approves weight-loss drug

The Food and Drug Administration has approved a new weight-loss drug made by Vivus, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new weight-loss drug made by Vivus, the agency said.

The FDA announced the approval of Qsymia (phentermine and topiramate) extended-release, designed for use by overweight and obese adults alongside a reduced-calorie diet and exercise for chronic weight management. The drug's original brand name was Qnexa.

July 16, 2012
Par subsidiary gets FDA nod for hypertension drug

A subsidiary of Par Pharmaceutical Cos. acquired earlier this year has received its first Food and Drug Administration approval.

WOODCLIFF LAKE, N.J. — A subsidiary of Par Pharmaceutical Cos. acquired earlier this year has received its first Food and Drug Administration approval.

Par said Par Formulations received approval from the FDA for labetalol hydrochloride tablets in the 100-mg, 200-mg and 300-mg strengths. The drug, a generic version of Prometheus Labs' Trandate, is used to treat hypertension.

Par acquired Par Formulations, formerly the Chennai, India-based drug maker Edict Pharmaceuticals, in February 2012.

July 13, 2012
FDA appoints new generic drugs office head

The main office of the Food and Drug Administration in charge of regulating generic drugs has appointed a new director, the agency said Friday.

SILVER SPRING, Md. — The main office of the Food and Drug Administration in charge of regulating generic drugs has appointed a new director, the agency said Friday.

The FDA announced the appointment of Gregory Geba as director of the Office of Generic Drugs, replacing acting director Keith Webber, effective Sunday.

Geba has served in various senior-level clinical and managerial positions in the drug industry for the past 15 years, most recently as deputy chief medical officer for Sanofi US, a subsidiary of French drug maker Sanofi.

July 13, 2012
PhRMA: More than 100 drugs under development for mental illnesses

Nearly 200 drugs for mental illnesses are under clinical development or under review by the Food and Drug Administration, the largest lobbying group for the drug industry said Thursday.

WASHINGTON — Nearly 200 drugs for mental illnesses are under clinical development or under review by the Food and Drug Administration, the largest trade group for the drug industry said Thursday.

The Pharmaceutical Research and Manufacturers of America released a report listing 187 drugs, including 52 for depression, 37 for schizophrenia and 26 for anxiety disorders.

July 12, 2012
FDA approves Watson arthritis drug

The Food and Drug Administration has approved a generic drug for arthritis made by Watson Pharmaceuticals, the company said.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic drug for arthritis made by Watson Pharmaceuticals, the company said.

Watson announced that the FDA approved a subsidiary's application for diclofenac sodium and misoprostol delayed-release tablets. The drug is a generic version of G.D. Searle's Arthrotec, used to treat osteoarthritis and rheumatoid arthritis in patients who have high risk of developing ulcers related to the use of non-steroidal anti-inflammatory drugs, or NSAIDs, a class that includes the painkiller ibuprofen.

July 12, 2012
Lilly announces negative results in schizophrenia drug trial

A clinical trial of a drug for schizophrenia did not yield the desired results, the drug's developer said.

INDIANAPOLIS — A clinical trial of a drug for schizophrenia did not yield the desired results, the drug's developer said.

Eli Lilly announced results of the H8Y-MC-HBBM study of pomaglumetad methionil, for patients with acute exacerbation of schizophrenia. The company said results did not show the drug produced a significantly different effect from the placebo.

July 10, 2012
Obama signs PDUFA reauthorization

President Barack Obama signed into law Monday what some called a "historic" reauthorization of the Prescription Drug User Fee Act.

WASHINGTON — President Barack Obama signed into law Monday what some called a "historic" reauthorization of the Prescription Drug User Fee Act.

July 6, 2012
FDA accepts NDA for Agile's contraceptive patch

The Food and Drug Administration has accepted a new drug application for a low-dose, once-weekly contraceptive patch from Agile Therapeutics, the drug maker said.

PRINCETON, N.J. — The Food and Drug Administration has accepted a new drug application for a low-dose, once-weekly contraceptive patch from Agile Therapeutics, the drug maker said.

July 5, 2012
FDA gives tentative approval to generic hypertension drug

Actavis has received a preliminary approval for a generic drug for treating high blood pressure, the drug maker said Thursday.

MORRISTOWN, N.J. — Actavis has received a preliminary approval for a generic drug for treating high blood pressure, the drug maker said Thursday.

June 22, 2012
Alexza resubmits Adasuve for regulatory review

A drug maker has resubmitted its new drug application to the Food and Drug Administration for an acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.

MOUNTAIN VIEW, Calif. — A drug maker has resubmitted its new drug application to the Food and Drug Administration for an acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.

Alexza Pharmaceuticals said it received a complete response letter for Adasuve last month from the regulatory agency. The CRL outlined the FDA's concerns about Alexza's manufacturing facility and the drug's draft product labeling. Alexza said it believes it has addressed these concerns in its resubmitted application.