Content about Amines

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.

 

April 24, 2013
FDA approves drug for opioid-induced constipation

The Food and Drug Administration has approved a new drug for constipation related to use of opioid painkillers made by Sucampo Pharmaceuticals and Takeda Pharmaceuticals, the drug makers said.

BETHESDA, Md. — The Food and Drug Administration has approved a new drug for constipation related to use of opioid painkillers made by Sucampo Pharmaceuticals and Takeda Pharmaceuticals, the drug makers said.

April 22, 2013
FDA approves Alcon's Simbrinza

The Food and Drug Administration has approved a drug made by Alcon, the drug maker said.

BASEL, Switzerland — The Food and Drug Administration has approved a drug made by Alcon, the drug maker said.

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. 

October 10, 2012
AccuDial launches line of Go-Green children's cough and cold products

AccuDial Pharmaceutical recently launched four products as part of its Go-Green pediatric liquid cough-cold lineup that features dosing information on a rotating label, a larger 6-point font and a dosing cup that's shrink-wrapped to the top of the container.

PALM BEACH GARDENS, Fla. — AccuDial Pharmaceutical recently launched four products as part of its Go-Green pediatric liquid cough-cold lineup that features dosing information on a rotating label, a larger 6-point font and a dosing cup that's shrink-wrapped to the top of the container.

September 13, 2012
FDA approves Lupin depression, anxiety drug

The Food and Drug Administration has approved a generic psychiatric drug made by Lupin Pharmaceuticals, Lupin said Thursday.

BALTIMORE — The Food and Drug Administration has approved a generic psychiatric drug made by Lupin Pharmaceuticals, Lupin said Thursday.

The Indian drug maker announced the approval of escitalopram tablets in the 5-mg, 10-mg and 20-mg strengths, used for acute and maintenance treatment of major depressive disorder in adults and adolescents and for acute treatment of general anxiety disorder in adults.

September 4, 2012
FDA's Nonprescription Drugs Advisory Committee to meet on Oxytrol Rx-to-OTC switch

According to a Food and Drug Administration post Friday, the FDA's Nonprescription Drugs Advisory Committee will be meeting Nov. 9 regarding the partial switch application from prescription to over the counter of Oxytrol (oxybutynin transdermal system), as submitted by MSD Consumer.

SILVER SPRING, Md. — According to a Food and Drug Administration post Friday, the FDA's Nonprescription Drugs Advisory Committee will be meeting Nov. 9 regarding the partial switch application from prescription to over the counter of Oxytrol (oxybutynin transdermal system) submitted by MSD Consumer. The proposed OTC product would be called Oxytrol for Women and would be indicated for the treatment of overactive bladder in women.

The prescription form of Oxytrol is licensed by Watson Pharma.

August 29, 2012
Nucynta ER approved as neuropathic pain treatment for DPN patients

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.

May 31, 2012
Tris Pharma, Perrigo to bring Delsym generic equivalent to market

Tris Pharma on Thursday announced that the Food and Drug Administration has approved its generic equivalent to Reckitt Benckiser's Delsym, an extended-release oral liquid suspension containing dextromethorphan.

MONMOUTH JUNCTION, N.J. — Tris Pharma on Thursday announced that the Food and Drug Administration has approved its generic equivalent to Reckitt Benckiser's Delsym, an extended-release oral liquid suspension containing dextromethorphan.

August 1, 2010
Smiling Planet announced partnership with Healthy Child Healthy World

Smiling Planet a new line of earth-friendly lifestyle products for kids, has joined the Healthy...

February 24, 2010
Fera commences shipment of eye-infection treatment

Fera Pharmaceuticals has begun shipping the full line of a topical drug for treating eye...

January 25, 2010
Fera launches erythromycin ophthalmic ointment

Fera Pharmaceuticals has launched a treatment for bacterial infections of the eye, the generic drug...