Content about New Drug Application

June 22, 2012

The Food and Drug Administration has issued a complete response letter regarding a supplemental new drug application for a medication developed by Janssen Research and Development.

RARITAN, N.J. — The Food and Drug Administration has issued a complete response letter regarding a supplemental new drug application for a medication developed by Janssen Research and Development.

June 19, 2012

The Food and Drug Administration has declined to approve a drug designed to treat a rare, progressive and fatal neurodegenerative disease.

NEW YORK — The Food and Drug Administration has declined to approve a drug designed to treat a rare, progressive and fatal neurodegenerative disease.

The FDA issued a complete response letter to Pfizer pertaining to the company's new drug application for tafamidis meglumine, requesting the completion of a second efficacy study to establish substantial evidence of effectiveness prior to an approval. The agency also has asked for additional information on the data within the current tafamidis NDA.

June 13, 2012

Merck on Wednesday released new data from two pivotal Phase III efficacy trials for suvorexant, the investigational medicine Merck is developing for the treatment of insomnia.

BOSTON — Merck on Wednesday released new data from two pivotal Phase III efficacy trials for suvorexant, the investigational medicine Merck is developing for the treatment of insomnia.

Merck expects to file a new drug application to the Food and Drug Administration in 2012. If approved, suvorexant would be the first medicine approved in a new class of medicines, called orexin receptor antagonists, for use in patients with difficulty falling or staying asleep. Merck anticipates that suvorexant will be evaluated by the Controlled Substance Staff of the FDA.

June 11, 2012

Avanir Pharmaceuticals confirmed that the Food and Drug Administration has accepted the company's investigational new drug application for an Alzheimer's disease drug.

ALISO VIEJO, Calif. — Avanir Pharmaceuticals confirmed that the Food and Drug Administration has accepted the company's investigational new drug application for an Alzheimer's disease drug.

Avanir said the FDA's acceptance of AVP-923, an investigational treatment of agitation in patients with Alzheimer's disease, marks the fourth IND for the AVP-923 program. The drug will be evaluated in a phase-2 clinical trial during third quarter 2012.

May 29, 2012

An experimental drug made by Pfizer for a rare and fatal neurodegenerative disease got a favorable vote from a Food and Drug Administration expert panel.

NEW YORK — An experimental drug made by Pfizer for a rare and fatal neurodegenerative disease got a favorable vote from a Food and Drug Administration expert panel.

The FDA's Peripheral and Central Nervous System Drugs Advisory Committee voted 13-4 that the drug tafamidis meglumine would provide certain clinical benefits to patients with transthyretin familial amyloid polyneuropathy, or TTR-FAP, a hereditary disease that affects about 8,000 people worldwide. The FDA is not required to follow the recommendations of FDA advisory committees, but usually does.

May 18, 2012

Perrigo on Friday announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug application for lansoprazole capsules in the 15-mg strength.

ALLEGAN, Mich. — Perrigo on Friday announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug application for lansoprazole capsules in the 15-mg strength. The capsules are a generic equivalent of Novartis' Prevacid 24HR capsules.

Sales for Prevacid OTC were approximately $220 million, Perrigo reported.


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May 2, 2012

The Food and Drug Administration has approved a generic drug for epilepsy made by Acella Pharmaceuticals, the company said Wednesday.

ATLANTA — The Food and Drug Administration has approved a generic drug for epilepsy made by Acella Pharmaceuticals, the company said Wednesday.

Acella announced the approval of gabapentin oral solution in the 250-mg-per-5-mL strength. The drug is a generic version of Parke Davis' Neurontin.

February 23, 2012

The Food and Drug Administration has accepted a new drug application for the treatment of idiopathic Parkinson’s disease.

HAYWARD, Calif. — The Food and Drug Administration has accepted a new drug application for the treatment of idiopathic Parkinson’s disease.

Impax Pharmaceuticals, the branded products division of Impax Labs, said it filed its NDA for the investigational drug IPX066, an extended-release capsule formulation of carbidopa-levodopa, for review in December 2011. IPX066 has been licensed to GlaxoSmithKline for countries outside the United States and Taiwan for development and marketing.

February 13, 2012

Columbia Labs has transferred a new drug application for a topical drug designed to prevent premature birth in pregnant women to Watson Pharmaceuticals.

LIVINGSTON, N.J. and PARSIPPANY, N.J. — Columbia Labs has transferred a new drug application for a topical drug designed to prevent premature birth in pregnant women to Watson Pharmaceuticals.

Columbia Labs said Watson now has full rights and regulatory responsibility for all activities and sponsor obligations relating to the application for progesterone vaginal gel 8%. Late last month, the drug received a thumbs-down from an FDA panel that declined to recommend approval for it.

The FDA is expected to take action on the NDA by Feb. 26.

January 20, 2012

For all the talk about generic drugs and their potential to save piles of money for the country’s healthcare system, it’s going to be a while before many of them actually reach consumers because of the Food and Drug Administration’s huge backlog of generic drug regulatory approval applications.


For all the talk about generic drugs and their potential to save piles of money for the country’s healthcare system, it’s going to be a while before many of them actually reach consumers because of the Food and Drug Administration’s huge backlog of generic drug regulatory approval applications.


January 3, 2012

The Food and Drug Administration's Oncologic Drugs Advisory Committee will review a resubmitted new drug application for a cancer treatment made by Cell Therapeutics.

SEATTLE — The Food and Drug Administration's Oncologic Drugs Advisory Committee will review a resubmitted new drug application for a cancer treatment made by Cell Therapeutics.

The company said that the panel will review the NDA for pixantrone, which is designed to treat relapsed or refractory aggressive non-Hodgkin's lymphoma in patients who failed two or more lines of prior therapy.

December 21, 2011

Drug maker Santarus has submitted a new drug application with the Food and Drug Administration for a treatment for ulcerative colitis, the company said.

SAN DIEGO — Drug maker Santarus has submitted a new drug application with the Food and Drug Administration for a treatment for ulcerative colitis, the company said.

The application was for Uceris (budesonide) tablets in the 9-mg strength for moderate active UC. The company is developing the drug under a collaboration with Cosmo Technologies.

 


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December 20, 2011

Pfizer is seeking approval from the Food and Drug Administration for its investigational treatment of moderately to severely active rheumatoid arthritis.

NEW YORK — Pfizer is seeking approval from the Food and Drug Administration for its investigational treatment of moderately to severely active rheumatoid arthritis.

The company said the FDA accepted a new drug application for tofacitinib for review. The agency also has provided an anticipated Prescription Drug User Fee Act action date of August 2012. Tofacitinib, which is a novel, oral JAK inhibitor, currently is under review by the European Medicines Agency.

November 28, 2011

A U.S. subsidiary of Takeda Pharmaceutical has filed for regulatory approval of a drug designed to treat Type 2 diabetes, the company said.

OSAKA, Japan — A U.S. subsidiary of Takeda Pharmaceutical has filed for regulatory approval of a drug designed to treat Type 2 diabetes, the company said.

The Takeda Global Research and Development Center filed with the Food and Drug Administration for approval of an alogliptin-metformin combination tablet. The company expects the FDA to review the application within the next 10 months.

November 10, 2011

The Food and Drug Administration has accepted a new drug application for a skin cancer treatment developed by Roche.

BASEL, Switzerland — The Food and Drug Administration has accepted a new drug application for a skin cancer treatment developed by Roche.

Roche said that the FDA accepted its NDA for vismodegib, designed to treat advanced basal cell carcinoma in adults for whom surgery is considered inappropriate. The application was granted priorit review status and has a confirmed action date of March 8, 2012.

November 2, 2011

The Food and Drug Administration has approved changes to the labeling of a cancer drug made by Takeda Pharmaceuticals, the drug maker said.

CAMBRIDGE, Mass. — The Food and Drug Administration has approved changes to the labeling of a cancer drug made by Takeda Pharmaceuticals, the drug maker said.

Takeda and Millennium, the Japanese drug maker's cancer-drug subsidiary, announced Tuesday that the FDA approved a supplemental new drug application for the injectable multiple myeloma drug Velcade (bortezomib) that updates its label to include additional data from a clinical study showing that the drug extended patients' survival time.

October 28, 2011

The Food and Drug Administration has approved a supplemental new drug application related to a drug made by Abbott, the company said.

ABBOTT PARK, Ill. — The Food and Drug Administration has approved a supplemental new drug application related to a drug made by Abbott, the company said.

October 27, 2011

A company focused on developing niche generic and specialty pharmaceutical products has received regulatory approval from the Food and Drug Administration for its version of a psychiatric drug.

PISCATAWAY, N.J. — A company focused on developing niche generic and specialty pharmaceutical products has received regulatory approval from the Food and Drug Administration for its version of a psychiatric drug.

Innopharma said its abbreviated new drug application for olanzapine injection, a generic equivalent of Zyprexa injection. With this approval, Innopharma announced that it has entered an agreement with Sandoz, who will sell, market and distribute Innopharma's generic in the United States.

October 25, 2011

Lannett has received approval from the Food and Drug Administration to market its version of an anti-obesity drug.

PHILADELPHIA — Lannett has received approval from the Food and Drug Administration to market its version of an anti-obesity drug.

The FDA approved Lannett's abbreviated new drug application for diethylpropion hydrochloride extended-release tablets in the 75-mg strength. The company expects to begin shipping the product immediately.

October 20, 2011

Vertex Pharmaceuticals has filed for Food and Drug Administration approval of a drug for cystic fibrosis, the company said.

CAMBRIDGE, Mass. — Vertex Pharmaceuticals has filed for Food and Drug Administration approval of a drug for cystic fibrosis, the company said.

Vertex announced the submission to the FDA of an application for approval and priority review of Kalydeco (ivacaftor), which it said was potentially the first medicine to target the underlying cause of cystic fibrosis, namely mutations in the CFTR gene that causes defective or missing CFTR proteins that inhibit the flow of salt and water across cell membranes and lead to mucus buildup.

October 11, 2011

The Food and Drug Administration has approved Mylan’s promethazine hydrochloride tablets, a generic drug for treating allergies, in the 12.5-mg, 25-mg and 50-mg strengths.

SUPPLIER NEWS — The Food and Drug Administration has approved Mylan’s promethazine hydrochloride tablets, a generic drug for treating allergies, in the 12.5-mg, 25-mg and 50-mg strengths. Promethazine hydrochloride tablets, which are manufactured by several companies, had sales of about $42 million during the 12-month period ended in June, according to IMS Health.


September 28, 2011

Chelsea Therapeutics International has applied for Food and Drug Administration approval of a drug for a disorder that affects patients with diseases like Parkinson's disease.

CHARLOTTE, N.C. — Chelsea Therapeutics International has applied for Food and Drug Administration approval of a drug for a disorder that affects patients with diseases like Parkinson's disease.

The drug maker announced the submission of a new drug application for Northera (droxidopa) as a treatment for neurogenic orthostatic hypotension. NOH predominantly affects people with primary autonomic failure, a group of diseases that includes Parkinson's, multiple system atrophy and pure autonomic failure.

September 7, 2011

The Food and Drug Administration has accepted a regulatory approval application for a drug made by Vivus for treating erectile dysfunction.

MOUNTAIN VIEW, Calif. — The Food and Drug Administration has accepted a regulatory approval application for a drug made by Vivus for treating erectile dysfunction.

Vivus said it expected the Food and Drug Administration to complete its review of the application for avanafil by April 29, 2012.

"We are pleased with FDA's acceptance of our NDA," Vivus president Peter Tam said. "If approved, avanafil could be a valuable treatment alternative for the 18 million men in the United States that suffer from ED."

September 1, 2011

The Food and Drug Administration has approved a new use for a follow-on biologic made by Sandoz.

PRINCETON, N.J. — The Food and Drug Administration has approved a new use for a follow-on biologic made by Sandoz.

Sandoz, the generic drugs arm of Swiss drug maker Novartis, announced the approval of Omnitrope (somatropin [rDNA origin]) for children with growth failure due to Turner syndrome. Sandoz said Omnitrope was now approved for all the same indications as the reference product, Pfizer's Genotropin.

August 30, 2011

The Food and Drug Administration has accepted a regulatory approval application from Progenics Pharmaceuticals and Salix Pharmaceuticals seeking an additional approval for a pain drug.

TARRYTOWN, N.Y. — The Food and Drug Administration has accepted a regulatory approval application from Progenics Pharmaceuticals and Salix Pharmaceuticals seeking an additional approval for a pain drug.

The two drug makers announced Tuesday that the FDA had accepted their supplemental new drug application for Relistor (methylnaltrexone bromide), an injectable drug for treating opioid-induced constipation.