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August 30, 2012

The Food and Drug Administration has approved a new drug for treating bowel diseases made by Ironwood Pharmaceuticals, the agency said Thursday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating bowel diseases made by Ironwood Pharmaceuticals, the agency said Thursday.

August 30, 2012

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 29, 2012

The Food and Drug Administration has approved a supplemental new drug application for an opioid analgesic to treat diabetes-related pain.

RARITAN, N.J. — The Food and Drug Administration has approved a supplemental new drug application for an opioid analgesic to treat diabetes-related pain.

August 23, 2012

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 13, 2012

An experimental drug therapy under development by Novartis for liver transplant patients appears to provide similar efficacy and better kidney function, compared with a drug made by Astellas Pharma, according to results of a late-stage clinical trial.

EAST HANOVER, N.J. — An experimental drug therapy under development by Novartis for liver transplant patients appears to provide similar efficacy and better kidney function, compared with a drug made by Astellas Pharma, according to results of a late-stage clinical trial.

A phase-3 study published in the American Journal of Transplantation found that patients taking RAD001 (everolimus) with a reduced dose of Astellas' Prograf (tacrolimus) experienced equal efficacy and superior kidney function to patients taking Prograf alone.

July 27, 2012

Horizon Pharma announced it has received regulatory approval from the Food and Drug Administration for one of its drugs.

DEERFIELD, Ill. — Horizon Pharma announced it has received regulatory approval from the Food and Drug Administration for one of its drugs.

The drug maker said Rayos (prednisone) delayed-release tablets — in the 1-mg, 2-mg and 5-mg stregnths — were approved for the treatment of rheumatoid arthritis, polymyalgia rheumatica, psoriatic arthritis, ankylosing spondylitis, asthma and chronic obstructive pulmonary disease.

July 13, 2012

The Food and Drug Administration has approved a generic contraceptive made by Watson Pharmaceuticals, the drug maker said Friday.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic contraceptive made by Watson Pharmaceuticals, the drug maker said Friday.

Watson announced the approval of Next Choice One Dose (levonorgestrel) tablets in the 1.5-mg strength. The drug is an emergency contraceptive used to prevent pregnancy following unprotected sex or contraceptive failure.

The drug is a generic version of Teva Women's Health's Plan B One-Step, which had sales of about $88 million during the 12-month period ended in March, according to IMS Health.

June 28, 2012

Mylan is challenging the patent protection on a Pfizer drug for treating depression, following an announcement of a similar challenge by Watson made earlier this week.

PITTSBURGH — Mylan is challenging the patent protection on a Pfizer drug for treating depression, following an announcement of a similar challenge by Watson made earlier this week.

Mylan said it had filed for Food and Drug Administration approval of a generic version of Pristiq (desvenlafaxine succinate) extended-release tablets in the 50-mg and 100-mg strengths.

June 25, 2012

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

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

Actavis, whose parent company was recently acquired by Watson Pharmaceuticals, announced the approval of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, also known as mixed-amphetamine salts ER capsules.

June 14, 2012

Stiefel, a GlaxoSmithKline company, on Monday acquired the eczema remedy Toctino (alitretinoin) from Basilea Pharmaceutica.

LONDON — Stiefel, a GlaxoSmithKline company, on Monday acquired the eczema remedy Toctino (alitretinoin) from Basilea Pharmaceutica.

“Toctino is an important and growing product that complements the Stiefel portfolio and offers a proven therapy for patients with a significant unmet medical need," stated Simon Jose, Stiefel president. "This acquisition gives us an immediate opportunity to develop and expand the availability of this new and innovative product of value, and reinforces Stiefel and GSK’s commitment to dermatology.”

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.

June 7, 2012

The Food and Drug Administration has approved a drug made by GlaxoSmithKline and XenoPort for treating pain associated with shingles.

NEW YORK — The Food and Drug Administration has approved a drug made by GlaxoSmithKline and XenoPort for treating pain associated with shingles.

The drug makers announced Thursday the approval of Horizant (gabapentin enacarbil) extended-release tablets for managing post-herpetic neuralgia. The drug already had FDA approval for treating restless legs syndrome. The approval entitles XenoPort to a $10 million milestone payment from GSK, according to a collaborative agreement between the two companies.

June 5, 2012

The Food and Drug Administration has approved a new dosage of an antibiotic drug made by Lupin Pharmaceuticals, Lupin said Tuesday.

BALTIMORE — The Food and Drug Administration has approved a new dosage of an antibiotic drug made by Lupin Pharmaceuticals, Lupin said Tuesday.

The Mumbai, India-based drug maker announced the approval of Suprax (cefixime) capsules in the 400-mg strength and plans to start shipping the drug "in the near future." The new approval adds to existing suspensions containing 100 mg per 5 mL and 200 mg per 5 mL.

The drug is used to treat infections such as pneumonia, gonorrhea and others.

April 27, 2012

A drug made by Novartis has received approval from the Food and Drug Administration to treat benign kidney tumors related to tuberous sclerosis complex.

EAST HANOVER, N.J. — A drug made by Novartis has received approval from the Food and Drug Administration to treat benign kidney tumors related to tuberous sclerosis complex.

The FDA approved Afinitor (everolimus) tablets for treating the tumors, known as renal angiomyolipomas, in adults with TSC who don't require surgery. The drug already was approved to treat brain tumors known as subependymal giant cell astrocytoma, or SEGA, in patients with TSC.

April 11, 2012

Prasco Labs will market an authorized generic version of a drug used to treat diarrhea caused by a bacterial infection, the company said Wednesday.

CINCINNATI — Prasco Labs will market an authorized generic version of a drug used to treat diarrhea caused by a bacterial infection, the company said Wednesday.

Prasco announced that it had signed a deal with ViroPharma to market an authorized generic version of Vancocin (vancomycin hydrochloride) capsules in the 125-mg and 250-mg strengths. The drug is used to treat diarrhea related to Clostridium difficile infection.

April 6, 2012

A panel of Food and Drug Administration experts has recommended approval for a drug made by Astellas Pharma for overactive bladder.

DEERFIELD, Ill. — A panel of Food and Drug Administration experts has recommended approval for a drug made by Astellas Pharma for overactive bladder.

The drug maker announced that the FDA Reproductive Health Drugs Advisory Committee voted 7-4 with one abstention that its assessment of the risks and benefits of the drug YM178 (mirabegron) supported the drug's approval.

The FDA is not required to follow the recommendations of advisory committees, but usually does. The agency is expected to decide whether or not to approve the drug by June 29.

March 27, 2012

The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating HIV in children.

TITUSVILLE, N.J. — The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating HIV in children.

J&J's Janssen Therapeutics division announced Tuesday the FDA approval of Intelence (etravirine) in patients ages 6 years to younger than 18 years with HIV-1 who have taken other therapies but whose infection has become resistant to treatment. The drug already was approved for adults.

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 17, 2012

The Food and Drug Administration has approved a drug made by Merck for Type 2 diabetes, the drug maker said. Merck announced the approval of Janumet XR (sitagliptin and metformin hydrochloride) extended-release tablets as a once-daily treatment for the disease.


SUPPLIER NEWS — The Food and Drug Administration has approved a drug made by Merck for Type 2 diabetes, the drug maker said. Merck announced the approval of Janumet XR (sitagliptin and metformin hydrochloride) extended-release tablets as a once-daily treatment for the disease.


January 31, 2012

The Food and Drug Administration has approved a drug made by Vertex Pharmaceuticals for treating a rare form of cystic fibrosis, the agency said Tuesday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Vertex Pharmaceuticals for treating a rare form of cystic fibrosis, the agency said Tuesday.

The FDA announced the approval of Kalydeco (ivacaftor) for treating patients ages 6 years and older with CF who have a mutation called G551D in the cystic fibrosis transmembrane regulator gene.

January 25, 2012

The Food and Drug Administration has approved a topical treatment made by Leo Pharma for a skin condition that can lead to cancer, the drug maker said Wednesday.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a topical treatment made by Leo Pharma for a skin condition that can lead to cancer, the drug maker said Wednesday.

Leo announced the FDA approval of Picato (ingenol mebutate) gel in the 0.015%/0.05% strength for actinic keratosis, also known as AK, which is a precancerous condition resulting from cumulative sun exposure that has the potential to lead to squamous cell carcinoma.

January 23, 2012

The Food and Drug Administration is streamlining the enrollment process for risk evaluation and mitigation strategies for a class of painkillers, the agency said.

SUPPLIER NEWS — The Food and Drug Administration is streamlining the enrollment process for risk evaluation and mitigation strategies for a class of painkillers, the agency said. The FDA announced the approval of a single REMS for transmucosal immediate-release fentanyl drugs. The new system, which takes effect in March, will allow prescribers and pharmacies to enroll into one system instead of individual systems for each product.

January 6, 2012

The Food and Drug Administration has granted fast-track designation to a drug currently under development by Achillion Pharmaceuticals for hepatitis C, the company said.

NEW HAVEN, Conn. — The Food and Drug Administration has granted fast-track designation to a drug currently under development by Achillion Pharmaceuticals for hepatitis C, the company said.

January 3, 2012

The Food and Drug Administration has approved a Pfizer vaccine for Streptococcus pneumoniae in adults ages 50 years and older, the company said.

NEW YORK — The Food and Drug Administration has approved a Pfizer vaccine for Streptococcus pneumoniae in adults ages 50 years and older, the company said.

Pfizer announced the FDA approval of Prevnar 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) as a single-dose for adults.

December 21, 2011

The Food and Drug Administration has approved an HIV drug for children and adolescents, the agency said Wednesday.

SILVER SPRING, Md. — The Food and Drug Administration has approved an HIV drug for children and adolescents, the agency said Wednesday.

The FDA announced the approval of Merck's Isentress (raltegravir) for HIV-1 infection in patients ages 2 to 18 years. The chewable form of the drug will be available for children ages 2 to 11 years.

"Many young children and adolescents are living with HIV, and this approval provides an important additional option for their treatment," FDA Office of Antimicrobial Products director Edward Cox said.