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May 15, 2013
FDA approves Genentech drug for lung cancer with genetic mutation

The Food and Drug Administration has approved a drug for a type of lung cancer.

SOUTH SAN FRANCISCO, Calif. — The Food and Drug Administration has approved a drug for a type of lung cancer.

Roche subsidiary Genentech and the U.S. subsidiary of Japan's Astellas Pharma announced the approval of Tarceva (erlotinib) for advanced non-small cell lung cancer whose tumors have mutations that activate the epidermal growth factor receptor. The FDA also approved a test to detect the mutation.

The drug was already approved for advanced NSCLC that did not exhibit the mutation.

 

May 10, 2013
FDA must file Plan B appeal by noon on May 13 or remove age restrictions from all OTC EC products

Senior U.S. District Judge Edward Korman on Friday denied a Food and Drug Administration motion for a stay pending an appeal of Korman's earlier decision that all levonorgestrel-based emergency contraceptives be available without a prescription and without any age restrictions.

NEW YORK — Senior U.S. District Judge Edward Korman on Friday denied a Food and Drug Administration motion for a stay pending an appeal of Korman's earlier decision that all levonorgestrel-based emergency contraceptives be available without a prescription and without any age restrictions. 

However, Korman did grant a stay "pending the hearing or submission of the defendants’ motion for a stay in the Court of Appeals on the condition that the motion for a stay be filed by noon on May 13, 2013."

March 20, 2013
Sandoz launches generic contraceptives

The Food and Drug Administration has approved and launched two generic contraceptives made by Sandoz, the drug maker said.

PRINCETON, N.J. — The Food and Drug Administration has approved and launched two generic contraceptives made by Sandoz, the drug maker said.

Sandoz, the generics division of Swiss drug maker Novartis, announced the approval of Estarylla (norgestimate and ethinyl estradiol tablets) and Tri-Estarylla (norgestimate and ethinyl estradiol tablets), generic versions of Johnson & Johnson's Ortho Cyclen and Ortho Tri-Cyclen, respectively. Sandoz said the launches brought the total number of oral contraceptives it has launched since the beginning of 2011 to six.

January 25, 2013
Merck: FDA approves Oxytrol for Women, creating overactive bladder category in OTC

Merck on Friday announced the Food and Drug Administration has approved the switch of Oxytrol for Women (oxybutynin transdermal system, 3.9 mg/day) from prescription-only to nonprescription, creating a new category — overactive bladder in women — in the OTC area.

WHITEHOUSE STATION, N.J. — Merck on Friday announced the Food and Drug Administration has approved the switch of Oxytrol for Women (oxybutynin transdermal system, 3.9 mg/day) from prescription-only to nonprescription, creating a new category — overactive bladder in women — in the OTC area. Most notable about this switch is the fact that the FDA approved Oxytrol for Women against the majority opinion of its Nonprescription Drug Advisory Committee, which voted five in favor and six opposed to the switch in November. 

January 22, 2013
FDA approves Lupin contraceptive

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

BALTIMORE — The Food and Drug Administration has approved a generic contraceptive made by Lupin Pharmaceuticals, the drug maker said Tuesday.

Lupin announced the approval of levonorgestrel and ethinyl estradiol tablets in the 0.1 mg/0.02 mg strength, a generic version of Watson Labs' Lutera.

Lutera had sales of about $103.6 million during the 12-month period that ended in September 2012, according to IMS Health.

December 28, 2012
Mylan launches new generic oral contraceptive

Mylan on Friday announced that its partner Famy Care has received final approval from the Food and Drug Administration for its abbreviated new drug application for levonorgestrel and ethinyl estradiol Tablets USP in the 0.15mg/0.03mg strength.

PITTSBURGH — Mylan on Friday announced that its partner Famy Care has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for levonorgestrel and ethinyl estradiol tablets USP in the 0.15mg/0.03mg strength.

The product is a generic version of Teva Branded Pharmaceutical Products' Nordette 28 Tablets, a form of oral contraception. The new product will be distributed in the United States by Mylan Pharmaceuticals, and the company is shipping the product immediately.

December 14, 2012
FDA approves new leukemia drug

The Food and Drug Administration has approved a new leukemia drug made by Ariad Pharmaceuticals, the agency said.

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

The FDA announced the approval of Iclusig (ponatinib) to treat chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia, also known respectively as CML and Ph+ ALL.

March 16, 2012
Patients taking oral cancer drugs may risk drug interactions, study finds

Pills for treating cancer have created numerous alternatives to spending hours in a clinic or at home receiving chemotherapy infusions, but risks of drug interactions remain, according to a new survey by the research arm of pharmacy benefit manager Medco Health Solutions.

WASHINGTON — Pills for treating cancer have created numerous alternatives to spending hours in a clinic or at home receiving chemotherapy infusions, but risks of drug interactions remain, according to a new survey by the research arm of pharmacy benefit manager Medco Health Solutions.

September 22, 2011
J&J HIV drug shows fewer side effects in trial data analysis

A new study has found that a recently approved drug for HIV produces fewer unpleasant side effects during the first three months of therapy than the standard treatment, according to published reports.

CHICAGO — A new study has found that a recently approved drug for HIV produces fewer unpleasant side effects during the first three months of therapy than the standard treatment, according to published reports.

July 21, 2010
Tibotec unveils efficacy results for investigational HIV drug

An investigational treatment for HIV made by Johnson & Johnson subsidiary Tibotec Pharmaceuticals works as...

June 7, 2010
Astellas completes acquisition of OSI

Japanese drug maker Astellas Pharma has completed its acquisition of OSI Pharmaceuticals, Astellas said Tuesday....

March 4, 2010
OrbiMed Advisors: Astellas should raise bid for OSI

One of the biggest holders of OSI Pharmaceuticals’ stock has said Japanese drug maker Astellas...

January 18, 2010
FDA extends review of lung cancer treatment

The Food and Drug Administration has extended its review period for a lung cancer drug...