Content about Clinical research

July 17, 2013

A federal court in New York has dismissed a lawsuit alleging that Mylan infringed four of Teva Pharmaceutical Industries' patents when it sought Food and Drug Administration approval for a multiple sclerosis drug.

PITTSBURGH — A federal court in New York has dismissed a lawsuit alleging that Mylan infringed four of Teva Pharmaceutical Industries' patents when it sought Food and Drug Administration approval for a multiple sclerosis drug.

Mylan had filed with the FDA for approval of a generic version of Teva's Copaxone (glatiramer acetate), attracting a patent-infringement suit from Teva alleging that it violated four patents on the drug, according to FDA records. The U.S. District Court for the Southern District of New York has dismissed the case.

July 16, 2013

Mylan has launched a generic contraceptive therapy, the drug maker said Tuesday.

PITTSBURGH — Mylan has launched a generic contraceptive therapy, the drug maker said Tuesday.

Mylan, through its Mylan Pharmaceuticals subsidiary, announced the launch of norethindrone tablets in the 0.35-mg strength. The drug is a generic version of Actavis' Nor-Q.D. tablets, which are taken on a 28-day cycle to prevent pregnancy. Mylan is partnering with Famy Care, which filed for and received Food and Drug Administration approval for the drug.

July 12, 2013

Actavis is looking to become the first to market a generic drug for epilepsy, the company said.

PARSIPPANY, N.J. — Actavis is looking to become the first to market a generic drug for epilepsy, the company said Friday.

Actavis announced that it had filed with the Food and Drug Administration for lacosamide tablets in the 50-mg, 100-mg, 150-mg and 200-mg strengths. The drug is a generic version of UBC's Vimpat and is used to treat partial-onset seizures in epilepsy patients aged 17 and older.

July 12, 2013

The Food and Drug Administration has approved a new lung cancer drug made by Boehringer Ingelheim, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new lung cancer drug made by Boehringer Ingelheim, the agency said Friday.

The FDA announced the approval of Gilotrif (afatinib) for patients with non-small cell lung cancer that has spread to other parts of the body and whose tumors include certain epidermal growth factor receptor gene mutations. The drug works by blocking proteins that promote the development of cancer cells.

July 12, 2013

The creation of a clear approval pathway for biosimilar drugs remains a daunting task for the Food and Drug Administration, despite the fact that it's prescribed by law through the Patient Protection and Affordable Care Act. But when those lower-priced, generic versions of some staggeringly expensive bioengineered medicines do finally come to market, they're likely to have a profound effect on the nation's outlays for specialty pharmaceuticals.

The creation of a clear approval pathway for biosimilar drugs remains a daunting task for the Food and Drug Administration, despite the fact that it's prescribed by law through the Patient Protection and Affordable Care Act. But when those lower-priced, generic versions of some staggeringly expensive bioengineered medicines do finally come to market, they're likely to have a profound effect on the nation's outlays for specialty pharmaceuticals.

July 12, 2013

The Indian generic drug maker announced the approval of repaglinide tablets in the 1-mg and 2-mg strengths, which are used in combination with diet and exercise to improve blood-sugar control in patients with Type 2 diabetes.

MUMBAI, India — The Food and Drug Administration has approved a generic diabetes drug made by Sun Pharmaceutical Industries, Sun said Friday.

The Indian generic drug maker announced the approval of repaglinide tablets in the 1-mg and 2-mg strengths, which are used in combination with diet and exercise to improve blood-sugar control in patients with Type 2 diabetes.

July 9, 2013

A total of 27 members of Congress issued a kind reminder to the Food and Drug Administration that many leaders across Capitol Hill are keeping tabs on New Dietary Ingredient guidance.

WASHINGTON — A total of 27 members of Congress on Monday issued a kind reminder to the Food and Drug Administration that many leaders across Capitol Hill are keeping tabs on New Dietary Ingredient guidance. 

The bipartisan correspondence, signed by key members on the Energy and Commerce Committee and the Dietary Supplement Caucus, praised the agency for its work with industry toward creating NDI notification processes. 

July 9, 2013

Mylan has received tentative approval for a generic version of a cholesterol drug made by AstraZeneca, according to Food and Drug Administration records.

SILVER SPRING, Md. — Mylan has received tentative approval for a generic version of a cholesterol drug made by AstraZeneca, according to Food and Drug Administration records.

The FDA gave the tentative approval to Mylan's rosuvastatin calcium tablets in the 5 mg, 10 mg, 20 mg and 40 mg strengths. The drug is a generic version of AstraZeneca's Crestor, which had sales of $5.1 billion in 2012, according to IMS Health.

July 9, 2013

The Food and Drug Administration has approved a new drug for treating opioid dependence.

NEW YORK — The Food and Drug Administration has approved a new drug for treating opioid dependence.

Orexo U.S. announced the approval of Zubsolv (buprenorphine; naloxone) sublingual tablets. The drug, Schedule III controlled substance, is approved for use once per day in the maintenance treatment of opioid dependence. Opioid dependence affects nearly 5 million people in the United States, according to the Substance Abuse and Mental Health Services Administration, but about 60% of those affected don't receive treatment.

July 9, 2013

The U.S. healthcare system has saved $25.5 billion over seven years from generic drugs launched under patent settlements between branded and generic drug manufacturers, according to a new study.

WASHINGTON — The U.S. healthcare system has saved $25.5 billion over seven years from generic drugs launched under patent settlements between branded and generic drug manufacturers, according to a new study.

July 8, 2013

Impax Labs has appointed Mary Pendergast to its board of directors, the generic drug maker said.

HAYWARD, Calif. — Impax Labs has appointed Mary Pendergast to its board of directors, the generic drug maker said.

Impax said Pendergast's appointment became effective last Wednesday. Pendergast is president of legal and regulatory consulting firm Pendergast Consulting. She previously served as deputy commissioner and senior adviser to the commissioner of the Food and Drug Administration for 18 years.

July 2, 2013

The Food and Drug Administration has approved a gel formulation of a foot fungus drug made by Merz Pharmaceuticals, according to published reports.

NEW YORK — The Food and Drug Administration has approved a gel formulation of a foot fungus drug made by Merz Pharmaceuticals, according to published reports.

According to reports, the FDA approved a gel formulation of Merz's Naftin (naftifine), used to treat athlete's foot, known medically as tinea pedis.

A cream version of the drug is already approved, and the latest approval was based on two clinical trials of more than 1,700 patients, according to reports.

 

July 2, 2013

Sandoz has started a late-stage clinical trial of a biosimilar version of a drug used to treat autoimmune disorders, hoping the results will support its efforts to win regulatory approval in the United States and Europe.

HOLZKIRCHEN, Germany — Sandoz has started a late-stage clinical trial of a biosimilar version of a drug used to treat autoimmune disorders, hoping the results will support its efforts to win regulatory approval in the United States and Europe.

Sandoz, the generics arm of Swiss drug maker Novartis, said it had started a phase-3 trial of biosimilar etanercept, a knock-off version of Amgen's Enbrel, used to treat chronic plaque-type psoriasis.

July 1, 2013

CVS/pharmacy has bolstered its mobile app by adding the new Drug Interaction Checker, which is an industry first that allows customers to easily check for potential drug interactions by comparing OTC products with their prescriptions and other OTCs on their smartphones.

WOONSOCKET, R.I. — CVS/pharmacy has bolstered its mobile app by adding the new Drug Interaction Checker, which is an industry first that allows customers to easily check for potential drug interactions by comparing OTC products with their prescriptions and other OTCs on their smartphones.

July 1, 2013

The Food and Drug Administration has declined to approve a sleeping pill made by Merck & Co., citing issues with dosage.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has declined to approve a sleeping pill made by Merck & Co., citing issues with dosage.

The drug maker said Monday that it received a complete response letter from the FDA concerning the drug suvorexant, for which it is seeking regulatory approval. A complete response letter means that the agency has finished reviewing its approval application, but questions remain that preclude final approval.

June 27, 2013

The Food and Drug Administration has approved what's being called the first therapy of its kind to prevent bleeding episodes.

SILVER SPRING, Md. — The Food and Drug Administration has approved what's being called the first therapy of its kind to prevent bleeding episodes.

The FDA announced Thursday the approval of Westlake Village, Calif.-based Baxter Healthcare Corp.'s Rixubis (coagulation factor IX [recombinant]) for patients with hemophilia B age 16 years and older. The treatment is used for controlling and preventing bleeding episodes, management of patients after surgery and routine use to prevent or reduce the frequency of bleeding episodes.

June 26, 2013

The Food and Drug Administration has approved a drug made by Astellas Pharma for treating fungal infections in children.

NORTHBROOK, Ill. — The Food and Drug Administration has approved a drug made by Astellas Pharma for treating fungal infections in children.

June 26, 2013

Mylan has launched a generic version of a Johnson & Johnson contraceptive, the company said Wednesday.

PITTSBURGH — Mylan has launched a generic version of a Johnson & Johnson contraceptive, the company said Wednesday.

Mylan announced the launch of norethindrone tablets in the 0.35 mg strength. The drug is a generic version of Micronor, made by J&J subsidiary Janssen Pharmaceuticals. A company partnering with Mylan on the drug, Famy Care, received approval from the Food and Drug Administration for the drug.

Various versions of the drug had sales of about $57.2 million during the 12-month period that ended in March, according to IMS Health.

June 25, 2013

Drug makers may be allowed to seek approval for a generic version of an eye drug made by Allergan based on lab tests rather than clinical trials, according to published reports.

NEW YORK — Drug makers may be allowed to seek approval for a generic version of an eye drug made by Allergan based on lab tests rather than clinical trials, according to published reports.

In a draft guidance released Friday, the FDA said that due to the efficacy profile of Allergan's drug for dry eyes Restasis (cyclosporine) ophthalmic emulsion, it wouldn't be effective for companies to conduct clinical trials to determine the efficacy of a generic version.

June 21, 2013

The Food and Drug Administration has approved a contraceptive pill for all women of childbearing potential without a prescription, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a contraceptive pill for all women of childbearing potential without a prescription, the agency said.

The FDA said the new approval of Teva Women's Health's Plan B One-Step (levonorgestrel) was to comply with an April 5 federal court order to make emergency contraceptives containing levonorgestrel available over the counter without age or point-of-sale restrictions.

June 18, 2013

The Food and Drug Administration's Center for Drug Evaluation and Research has collected 84% of the fees it intends to collect this year under a law passed last year to collect user fees from generic drug members, according to a memo sent out to CDER staff Tuesday.

NEW YORK — The Food and Drug Administration's Center for Drug Evaluation and Research has collected 84% of the fees it intends to collect this year under a law passed last year to collect user fees from generic drug members, according to a memo sent out to CDER staff Tuesday.

CDER director Janet Woodcock wrote that the FDA had collected more than $255 million under the Generic Drug User Fee Amendments to the 2012 Prescription Drug User Fee Act reauthorization. The agency plans to collect $299 million in fiscal year 2013.

June 17, 2013

Patent settlements between brand and generic drug makers commonly referred to as "pay-for-delay" settlements are not necessarily against the law, the Supreme Court ruled Monday.

NEW YORK — Patent settlements between brand and generic drug makers commonly referred to as "pay-for-delay" settlements are not necessarily against the law, the Supreme Court ruled Monday.

June 13, 2013

The Food and Drug Administration has approved a drug made by Amgen for treating a rare and usually noncancerous bone tumor, the agency said Thursday.

SILVER SPRING, Md. – The Food and Drug Administration has approved a drug made by Amgen for treating a rare and usually noncancerous bone tumor, the agency said Thursday.

June 10, 2013

A 26-member joint panel comprising the Food and Drug Administration's Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management advisory committees voted to support modifying or removing the risk evaluation and mitigation strategy protocol for GlaxoSmithKline's Type 2 diabetes drug Avandia (rosiglitazone).

Historically, the FDA has followed advisory committee votes when making a decision on the marketing of a drug even though it is not bound by them, but assuming the agency follows the panel's advice, it could mean a lot for the controversial drug and the way it's dispensed. But even if Avandia winds up on retail pharmacy shelves again, it faces a very different landscape from its heyday.

A 26-member joint panel comprising the Food and Drug Administration's Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management advisory committees voted to support modifying or removing the risk evaluation and mitigation strategy protocol for GlaxoSmithKline's Type 2 diabetes drug Avandia (rosiglitazone).

June 6, 2013

The Food and Drug Administration has approved a drug made by Celgene for treating a type of cancer.

SUMMIT, N.J. — The Food and Drug Administration has approved a drug made by Celgene Corp. for treating a type of cancer.

Celgene announced Thursday the approval of Revlimid (lenalidomide) for treatment of patients with mantle cell lymphoma, also known as MCL, whose disease has relapsed or progressed after two prior therapies that have included bortezomib.