Content about Food and Drug Administration

April 14, 2011

The Food and Drug Administration has received reports of a rare and usually deadly cancer in patients using a class of biotech drugs to treat autoimmune and inflammatory diseases, the agency said Thursday.

SILVER SPRING, Md. — The Food and Drug Administration has received reports of a rare and usually deadly cancer in patients using a class of biotech drugs to treat autoimmune and inflammatory diseases, the agency said Thursday.

April 13, 2011

The Food and Drug Administration has accepted a regulatory approval application for a topical treatment for low testosterone made by Teva Pharmaceuticals and BioSante Pharmaceuticals, BioSante said Wednesday.

LINCOLNSHIRE, Ill. — The Food and Drug Administration has accepted a regulatory approval application for a topical treatment for low testosterone made by Teva Pharmaceuticals and BioSante Pharmaceuticals, BioSante said Wednesday.

The two companies said the FDA had accepted their application for Bio-T-Gel and expected to complete its review by mid-November.

April 13, 2011

A Food and Drug Administration expert panel has given a favorable vote to a drug made by Pfizer for tumors, Pfizer said Tuesday.

NEW YORK — A Food and Drug Administration expert panel has given a favorable vote to a drug made by Pfizer for tumors, Pfizer said Tuesday.

The FDA’s Oncologic Drugs Advisory Committee voted 8-2 that Sutent’s (sunitinib malate) benefits outweigh its risks in the treatment of unresectable pancreatic neuroendocrine tumors.

While the FDA is not bound by advisory committee votes, it takes them into consideration when deciding whether or not to approve a drug.

April 12, 2011

Perrigo on Tuesday announced that the Detroit office of the Food and Drug Administration has concluded its re-inspection of Perrigo's Allegan facility.

ALLEGAN, Mich. — Perrigo on Tuesday announced that the Detroit office of the Food and Drug Administration has concluded its re-inspection of Perrigo's Allegan facility.

The FDA has informed Perrigo that, effective immediately, Perrigo has an acceptable regulatory status, such that any pending export license and abbreviated new drug applications from this facility will once again be eligible for review and approval.

April 12, 2011

The Food and Drug Administration has approved a treatment made by Merck for treating skin cancer, Merck said Monday.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has approved a treatment made by Merck for treating skin cancer, Merck said Monday.

Merck announced the approval of Sylatron (peginterferon alfa-2b) as an add-on treatment for treating melanoma with microscopic of gross nodal involvement within 84 days of surgery.

April 11, 2011

Another generic drug maker is seeking to market its version of a popular opioid painkiller.

HAYWARD, Calif. — Another generic drug maker is seeking to market its version of a popular opioid painkiller.

Impax said it had filed applications with the Food and Drug Administration seeking approval for a generic version of Purdue Pharma’s Oxycontin (oxycodone) controlled-release tablets in the 10-, 15-, 20-, 30-, 40-, 60- and 80-mg strengths.

Purdue filed suit against Impax on April 8 in the U.S. District Courts for the Southern District of New York, seeking to prevent Impax from marketing its version before the expiration of Purdue's patents.

April 11, 2011

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

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

J&J said Monday that the FDA had approved Invega (paliperidone) extended-release tablets for patients ages 12 to 17 years. The drug is marketed by J&J subsidiary Ortho-McNeil-Janssen Pharmaceuticals. The drug originally was approved in 2006 for treating schizophrenia in adults.

April 11, 2011

The Food and Drug Administration has approved an oral contraceptive made by Sandoz, the company said Friday.

PRINCETON, N.J. — The Food and Drug Administration has approved an oral contraceptive made by Sandoz, the company said Friday.

Sandoz, the generics division of Swiss drug maker Novartis, announced the approval of Altavera (levonorgestrel and ethinyl estradiol) tablets, a generic version of Duramed’s Nordette.

Branded and generic versions of Nordette had sales of about $57.4 million during the 12-month period ended in February, according to IMS Health.

April 8, 2011

The Food and Drug Administration has granted tentative approval to a generic antibiotic made by Hi-Tech Pharmacal, the drug maker said Friday.

AMITYVILLE, N.Y. — The Food and Drug Administration has granted tentative approval to a generic antibiotic made by Hi-Tech Pharmacal, the drug maker said Friday.

Hi-Tech announced the tentative approval of levofloxacin oral solution in the 25 mg-per-mL strength. The drug is used to treat mild, moderate and severe bacterial infections in adults.

April 8, 2011

Watson announced that its subsidiary is seeking approval to market a generic version of a bacterial conjunctivitis treatment.

PARSIPPANY, N.J. — Watson announced that its subsidiary is seeking approval to market a generic version of a bacterial conjunctivitis treatment.

Watson Labs filed an abbreviated new drug application with the Food and Drug Administration for moxifloxacin hydrochloride ophthalmic solution USP in the 0.5% strength. The antibiotic solution is a generic version of Alcon's Vigamox, which had total U.S. sales of about $281 million ended in February, according to IMS Health.

April 7, 2011

The Food and Drug Administration has approved a drug made by AstraZeneca for treating a rare form of thyroid cancer, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by AstraZeneca for treating a rare form of thyroid cancer, the agency said.

The FDA announced the approval of the daily pill vandetanib for late-stage medullary thyroid cancer in patients whose disease is growing and causing symptoms but who are ineligible for surgery.

Medullary thyroid cancer involves specific cells found in the thyroid gland and can occur spontaneously or be part of a genetic disease. There currently are no FDA-approved treatments for this cancer.

April 7, 2011

U.S. marshals have seized more than $6 million in products distributed by Triad Group at the company’s facility in Hartland, Wis., the Food and Drug Administration reported Wednesday.

SILVER SPRING, Md. — U.S. marshals have seized more than $6 million in products distributed by Triad Group at the company’s facility in Hartland, Wis., the Food and Drug Administration reported Wednesday.

“We took this action to stop Triad from continuing to distribute products [that] may pose a risk to public health,” stated Dara Corrigan, FDA associate commissioner for regulatory affairs.

April 7, 2011

The Food and Drug Administration on Thursday posted a notification to healthcare professionals and patients that the agency continues to receive reports of methemoglobinemia, a serious and potentially fatal adverse effect, associated with benzocaine products, which are available as a spray, gel and liquids sold over the counter.

SILVER SPRING, Md. — The Food and Drug Administration on Thursday posted a notification to healthcare professionals and patients that the agency continues to receive reports of methemoglobinemia, a serious and potentially fatal adverse effect, associated with benzocaine products, which are available as a spray, gel and liquids sold over the counter. Benzocaine products are used to relieve pain from a variety of conditions, such as teething, canker sores, and irritation of the mouth and gums.

April 7, 2011

The Food and Drug Administration has approved a drug made by GlaxoSmithKline and Xenoport for treating restless legs syndrome, the agency said Thursday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by GlaxoSmithKline and Xenoport for treating restless legs syndrome, the agency said Thursday.

The FDA approved Horizant (gabapentin enacarbil) as a once-daily treatment for moderate-to-severe RLS.

“People with restless legs syndrome can experience considerable distress from their symptoms,” FDA Division of Neurology Products director Russell Katz said. “Horizant provides significant help in treating these symptoms.”

April 6, 2011

The Center for Healthcare Supply Chain Research, the research foundation of the Healthcare Distribution Management Association, on Tuesday released “Assessing the Impact of Risk Evaluation and Mitigation Strategies (REMS) Requirements on the Pharmaceutical Supply Chain,” the first comprehensive research study analyzing the impact of REMS programs across the healthcare supply chain.

ARLINGTON, Va. — The Center for Healthcare Supply Chain Research, the research foundation of the Healthcare Distribution Management Association, on Tuesday released “Assessing the Impact of Risk Evaluation and Mitigation Strategies (REMS) Requirements on the Pharmaceutical Supply Chain,” the first comprehensive research study analyzing the impact of REMS programs across the healthcare supply chain.

April 5, 2011

The Food and Drug Administration Tuesday unveiled its easier-to-use search engine for consumers that are concerned about food and other product recalls.

SILVER SPRING, Md. — The Food and Drug Administration Tuesday unveiled its easier-to-use search engine for consumers that are concerned about food and other product recalls.

April 5, 2011

Generic drug maker Impax Labs is hoping to become the first to market a version of a gastroesophageal reflux disease treatment made by Takeda Pharmaceutical.

HAYWARD, Calif. — Generic drug maker Impax Labs is hoping to become the first to market a version of a gastroesophageal reflux disease treatment made by Takeda Pharmaceutical.

Impax said Tuesday that it had filed an approval application with the Food and Drug Administration for dexlansoprazole delayed-release capsules in the 30-mg and 60-mg strengths. The drug is a version of Takeda’s Dexilant.

April 5, 2011

The Food and Drug Administration has approved Boehringer Ingelheim Pharmaceuticals' single-pill antiretroviral for HIV-1 patients, BI said Tuesday.

RIDGEFIELD, Conn. — The Food and Drug Administration has approved Boehringer Ingelheim Pharmaceuticals' single-pill antiretroviral for HIV-1 patients, BI said Tuesday.

The FDA approved Viramune XR (nevirapine), a single-pill, once-daily, extended-release formulation of nevirapine for use in combination with other antiretroviral drugs.

April 4, 2011

Canadian drug maker Intellipharmaceutics International is seeking approval for a generic version of a treatment for mental disorders.

TORONTO — Canadian drug maker Intellipharmaceutics International is seeking approval for a generic version of a treatment for mental disorders.

Intellipharmaceutics announced Monday that it had filed an application with the Food and Drug Administration for quetiapine fumarate extended-release tablets, a generic version of AstraZeneca’s Seroquel XR.

April 4, 2011

The Food and Drug Administration has approved a generic drug made by Mylan that reduces pressure in the eye, Mylan said Monday.

PITTSBURGH — The Food and Drug Administration has approved a generic drug made by Mylan that reduces pressure in the eye, Mylan said Monday.

Mylan announced the approval of latanoprost ophthalmic solution in the 0.005% strength. The drug is a generic version of Xalatan, made by Pharmacia and Upjohn, now part of Pfizer.

Various versions of the drug had sales of around $711 million in 2010, according to IMS Health.

April 4, 2011

A drug used to treat pain in cancer patients now is available in the United States.

BEDMINSTER, N.J. — A drug used to treat pain in cancer patients now is available in the United States.

ProStrakan Group announced Monday the launch of Abstral (fentanyl) sublingual tablets. The tablets, which disintegrate rapidly and are placed under the tongue, treat breakthrough pain, common in one-half to two-thirds of people with cancer-related pain.

The drug, an opioid and controlled substance, only is available through a Food and Drug Administration-mandated REMS program. The FDA approved the drug in January.

April 1, 2011

An investigational drug for Parkinson’s disease was safe and effective, according to results of a late-stage clinical trial scheduled for presentation next week.

HAYWARD, Calif. — An investigational drug for Parkinson’s disease was safe and effective, according to results of a late-stage clinical trial scheduled for presentation next week.

Impax Pharmaceuticals, the branded products division of Impax Labs, said it would present data from a phase-3 trial of extended-release IPX066 (carbidopa-levodopa) at the American Academy of Neurology Conference’s annual meeting in Hawaii, which takes place from April 9 through April 16.

The company also said there were no unexpected serious side effects observed in patients.

April 1, 2011

The Food and Drug Administration has approved a generic treatment for iron deficiency anemia made by Watson Pharmaceuticals, Watson said Thursday.

MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic treatment for iron deficiency anemia made by Watson Pharmaceuticals, Watson said Thursday.

The drug maker announced the approval of Nulecit (sodium ferric gluconate complex in sucrose), an injectable and generic version of Sanofi-Aventis’ Ferrlecit.

The drug is used to treat iron deficiency anemia in adults and children ages 6 years and older undergoing chronic hemodialysis and receiving supplemental epoetin therapy.

March 31, 2011

Indian generic drug maker Aurobindo has received two approvals from the Food and Drug Administration.

HYDERABAD, India — Indian generic drug maker Aurobindo has received two approvals from the Food and Drug Administration.

The company said Wednesday that it received approval for galantamine tablets in the 4-, 8- and 12-mg strengths. The drug is a version of Johnson & Johnson’s Alzheimer’s treatment Razadyne; various versions of the drug had sales of $41 million during the 12 months ended in September 2010, according to IMS Health.

March 31, 2011

Usually, when the Food and Drug Administration approves a commercial version of a drug, it prohibits compounding pharmacies from producing it, but it’s making an exception in the case of a drug used to prevent premature births.

SILVER SPRING, Md. — Usually, when the Food and Drug Administration approves a commercial version of a drug, it prohibits compounding pharmacies from producing it, but it’s making an exception in the case of a drug used to prevent premature births.