Content about Clinical research

November 8, 2013

Sanofi-Aventis has sued the Food and Drug Administration to keep its labeling for OTC Nasacort confidential in an effort to delay store brand competition until after the launch, according to an entry in the FDA Law Blog, the official blog of Hyman, Phelps & McNamara, published Thursday.

WASHINGTON — Sanofi-Aventis has sued the Food and Drug Administration to keep its labeling for OTC Nasacort confidential in an effort to delay store brand competition until after the launch, according to an entry in the FDA Law Blog, the official blog of Hyman, Phelps & McNamara, published Thursday. 

November 8, 2013

When the maker of a branded drug updates the safety information on its product labeling, makers of generic versions of that drug must wait until the Food and Drug Administration approves the new labeling before they can update theirs, but that could soon change under a rule proposed by the FDA.

SILVER SPRING, Md. — When the maker of a branded drug updates the safety information on its product labeling, makers of generic versions of that drug must wait until the Food and Drug Administration approves the new labeling before they can update theirs, but that could soon change under a rule proposed by the FDA.

November 5, 2013

The Food and Drug Administration has approved a generic injectable antibiotic drug made by Emcure Pharmaceuticals, according to the agency.

SILVER SPRING, Md. – The Food and Drug Administration has approved a generic injectable antibiotic drug made by Emcure Pharmaceuticals, according to the agency.

The FDA approved Emcure's vancomycin hydrochloride injection in the 5-g-per-vial strength.

The drug is a generic version of Vancocin, made by ViroPharma.

 

November 5, 2013

The Food and Drug Administration has approved a generic drug made by Mylan for treating overactive bladder, according to agency records.

SILVER SPRING, Md. — The Food and Drug Administration has approved a generic drug made by Mylan for treating overactive bladder, according to agency records.

The FDA approved Mylan's tolterodine tartrate extended-release capsules in the 2-mg and 4-mg strengths.

The drug is a generic version of Pfizer's Detrol LA. Detrol LA has annual sales of about $700 million, according to published reports.

 

November 5, 2013

A recently released clinical trial has found that patients taking a biotech drug for arthritis and those taking a biosimilar version had similar responses to both treatments.

LAKE FOREST, Ill. — A recently released clinical trial has found that patients taking a biotech drug for arthritis and those taking a biosimilar version had similar responses to both treatments.

November 4, 2013

The Food and Drug Administration has asked Ariad Pharmaceuticals to suspend marketing and sales of a chemotherapy drug for leukemia due to the risk of life-threatening side effects, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has asked Ariad Pharmaceuticals to suspend marketing and sales of a chemotherapy drug for leukemia due to the risk of life-threatening side effects, the agency said.

November 1, 2013

Indian drug maker Dr. Reddy's Labs had sales of $536 million in second quarter 2014 and profits of $110 million, the company said.

HYDERABAD, India — Indian drug maker Dr. Reddy's Labs had sales of $536 million in second-quarter 2014 and profits of $110 million, the company said.

Those figures represented sales growth of 17% and a 76% growth in profits over second quarter 2013. Seventy-nine percent of the company's sales came from generic drugs, including 50% from sales in North America; sales of generics grew by 32% over last year.

November 1, 2013

The Food and Drug Administration has approved a new drug for leukemia made by Genentech, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for leukemia made by Genentech, the agency said Friday.

The FDA announced the approval of Gazyva (obinutuzumab) for treating patients with previously untreated chronic lymphocytic leukemia, in combination with the chemotherapy drug chlorambucil. The drug works by helping certain cells in the immune system attack cancer cells.

October 31, 2013

Actavis is seeking Food and Drug Administration approval for a generic drug used to treat acne, triggering a lawsuit in a federal court from the maker of the branded version, the company said Thursday.

DUBLIN — Actavis is seeking Food and Drug Administration approval for a generic drug used to treat acne, triggering a lawsuit in a federal court from the maker of the branded version, the company said Thursday.

The drug maker said it had filed with the FDA for approval of isotretinoin capsules in the 10-mg, 20-mg, 30-mg and 40-mg strengths. The drug is a generic version of Ranbaxy's Absorica, a retinoid used to treat severe, recalcitrant nodular acne in patients 12 and older.

October 31, 2013

The Food and Drug Administration is using long-term strategies to address drug shortages when they appear and requiring manufacturers to notify the agency if a shortage is at risk of happening, under a new plan announced Thursday.

SILVER SPRING, Md. — The Food and Drug Administration is using long-term strategies to address drug shortages when they appear and requiring manufacturers to notify the agency if a shortage is at risk of happening, under a new plan announced Thursday.

October 31, 2013

Impax Labs and Tolmar announced that the Food and Drug Administration has given final approval to Tolmar's generic version of Solaraze gel.

HAYWARD, Calif., and FORT COLLINS, Colo.  — Impax Labs and Tolmar announced that the Food and Drug Administration has given final approval to Tolmar's generic version of Solaraze (diclofenac sodium) gel in the 3% strength.

October 30, 2013

Tria Beauty, a maker of light-based skin care, has received FDA clearance for the company's Age-Defying Laser, the company has announced.

DUBLIN, Calif. — Tria Beauty, a maker of light-based skin care, has received clearance from the Food and Drug Administration for the company's Age-Defying Laser, the company has announced.

October 29, 2013

In what is emerging as the latest battle over follow-on biologics, a new argument has emerged about what to call them, and supporters of biotechnology companies are the latest to take a shot.

NEW YORK — In what is emerging as the latest battle over follow-on biologics, a new argument has emerged about what to call them, and supporters of biotechnology companies are the latest to take a shot.

October 29, 2013

Generic drug maker Amneal Pharmaceuticals is seeking Food and Drug Administration approval for a gout drug, prompting a lawsuit from the maker of the branded version, according to published reports.

NEW YORK — Generic drug maker Amneal Pharmaceuticals is seeking Food and Drug Administration approval for a gout drug, prompting a lawsuit from the maker of the branded version, according to published reports.

Law360 reported that Takeda Pharmaceuticals USA had sued Amneal in the U.S. District Court for the District of Delaware over the drug Colcrys (colchicine), used to treat gout and familial Mediterranean fever.

October 28, 2013

The Food and Drug Administration has launched an online learning course aimed at healthcare professionals to educate them about potentially untruthful or misleading drug ads and promotional materials.

SILVER SPRING, Md. — The Food and Drug Administration has launched an online learning course aimed at healthcare professionals to educate them about potentially untruthful or misleading drug ads and promotional materials.

October 25, 2013

A Food and Drug Administration expert panel has recommended approval for a drug made by Johnson & Johnson for treating hepatitis C, the company said.

NEW YORK — A Food and Drug Administration expert panel has recommended approval for a drug made by Johnson & Johnson for treating hepatitis C, the company said.

J&J subsidiary Janssen Research & Development said the 19-member FDA Antiviral Drugs Advisory Committee voted unanimously to recommend approval for TMC435 (simeprevir), a 150-mg drug meant for administration once per day with the generic antiviral ribavirin and a biotech drug known as an interferon, for treating genotype 1 chronic hepatitis C.

October 24, 2013

An experimental drug under development by Gilead Sciences for hepatitis C is safe and effective when combined with other treatments, according to a review posted on the Food and Drug Administration's website ahead of an expert panel meeting to take place Friday.

NEW YORK — An experimental drug under development by Gilead Sciences for hepatitis C is safe and effective when combined with other treatments, according to a review posted on the Food and Drug Administration's website ahead of an expert panel meeting to take place Friday.

October 24, 2013

The Food and Drug Administration has granted breakthrough therapy designation to an experimental drug made by Merck for hepatitis C, the drug maker said.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has granted breakthrough therapy designation to an experimental drug made by Merck for hepatitis C, the drug maker said.

October 22, 2013

A top executive of generic drug maker Hospira spoke in favor of giving biosimilar drugs the same generic names as the branded biologics they're based on.

LAKE FOREST, Ill. — A top executive of generic drug maker Hospira spoke in favor of giving biosimilar drugs the same generic names as the branded biologics they're based on.

October 22, 2013

The Food and Drug Administration has approved a generic contraceptive drug made by Famy Care, agency records show.

SILVER SPRING, Md. — The Food and Drug Administration has approved a generic contraceptive drug made by Famy Care, agency records show.

The agency approved Famy's levonorgestrel and ethinyl estradiol tablets in the 0.02-mg/0.1-mg strengths.

The drug is a generic version of Aviane-28, made by Teva Women's Health, a division of Israeli drug maker Teva Pharmaceutical Industries that previously went under the name Duramed.

 

October 21, 2013

The Food and Drug Administration has approved a pain drug made by Iroko Pharmaceuticals, Iroko said.

PHILADELPHIA — The Food and Drug Administration has approved a pain drug made by Iroko Pharmaceuticals, Iroko said.

The drug maker announced the approval of Zorvolex (diclofenac) capsules for mild to moderate acute pain in adults. The drug is a non-steroidal anti-inflammatory drug, or NSAID, belonging to the same class as the common analgesic drug ibuprofen. Zorvolex was approved at dosage strengths 20% lower than currently available diclofenac products, the company said.

October 21, 2013

The Food and Drug Administration is offering more than $14 million in grants for the development of products for patients with rare diseases, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration is offering more than $14 million in grants for the development of products for patients with rare diseases, the agency said Monday.

October 18, 2013

The Food and Drug Administration has approved a pre-filled injector pen made by EMD Serono for infertile women, the company said Friday.

DARMSTADT, Germany — The Food and Drug Administration has approved a pre-filled injector pen made by EMD Serono for infertile women, the company said Friday.

The drug maker — the U.S. subsidiary of Germany's Merck Serono, so-called to distinguish it from U.S.-based Merck & Co. — announced the approval of Gonal-f RFF Redi-ject (follitropin alfa), a disposable pre-filled injector pen intended for injection under the skin of a liquid formulation of Gonal-f RFF. The pens will be available in the United States in December.

October 17, 2013

The Food and Drug Administration has approved a new drug made by Novo Nordisk for treating hemophilia A, the Danish drug maker said.

BAGSVÆRD, Denmark — The Food and Drug Administration has approved a new drug made by Novo Nordisk for treating hemophilia A, the Danish drug maker said.

Novo Nordisk announced the approval of Novoeight (turoctocog alfa), a recombinant coagulation factor VIII, for adults and children with hemophilia, a disease caused by factor VIII deficiency that results in uncontrollable bleeding.

October 15, 2013

The Food and Drug Administration has approved a new generic drug from Teva Pharmaceutical Industries for treating eye infections, the company said.

JERUSALEM — The Food and Drug Administration has approved a new generic drug from Teva Pharmaceutical Industries for treating eye infections, the company said.

The Israeli drug maker announced the approval of the antibiotic drug tobramycin inhalation solution, a generic version of Novartis' Tobi.

Tobi has sales of about $350 million during the 12-month period that ended in June, according to IMS Health.