Content about Paracetamol

PITTSBURGH — The Food and Drug Administration has approved a generic migraine drug made by Mylan, the company said Wednesday.

Mylan announced the approval of zolmitriptan tablets in the 2.5 mg and 5 mg strengths. The drug maker plans to launch the product immediately.

The drug is a generic version of IPR Pharmaceuticals' Zomig and is used for the acute treatment of migraine in adults. Various versions of the drug had sales of $152.8 million during the 12-month period that ended in March, according to IMS Health.

DUBLIN — The Food and Drug Administration has approved a new strength of an antibiotic made by Warner Chilcott, the drug maker said.

Warner Chilcott announced the approval of the 200-mg strength of Doryx (doxycycline hyalite) delayed-release tablets, which the company plans to release in July 2013.

Doryx delayed-release tablets are already available in the 75-mg, 100-mg and 150-mg strengths.

PHILADELPHIA — The Food and Drug Administration has accepted a regulatory application for a new painkiller from Iroko Pharmaceuticals, the drug maker said Monday.

Iroko is seeking approval for a lower-dose, submicron diclofenac, a non-steroidal anti-inflammatory drug for treating mild to moderate acute pain in adults.

CINCINNATI — Procter & Gamble and Teva Pharmaceutical on Monday gained European Union approval for a joint venture on the sale of nonprescription medicines to be called PGT Healthcare, according to published reports. 

According to the reports, the joint venture didn't raise competition concerns. P&G will have a 51% stake in the venture. 

PARSIPPANY, N.J. — Watson Pharmaceuticals announced that its subsidiary, Watson Laboratories, has received Food and Drug Administration approval on its abbreviated new drug application for irbesartan tablets — the generic equivalent to Sanofi's Avapro — in the 75-mg, 150-mg and 300-mg strengths.

PARSIPPANY, N.J. — Generic drug maker Watson Labs recalled two lots of a prescription painkiller due to the potential for oversized and overly potent tablets, the company said.

The drug maker announced the recall of hydrocodone bitartrate and acetaminophen tablets in the 10 mg/500 mg strengths based on a customer complaint of tablets that were thicker and darker-colored than the others.

MORRISTOWN, N.J. — Bayer HealthCare's Consumer Care Division on Tuesday introduced Bayer Migraine Formula, an over-the-counter medication designed to relieve migraine pain and accompanying symptoms like nausea, phonophobia (sound sensitivity) and photophobia (light sensitivity) through a formulation of aspirin, acetaminophen and caffeine.

WASHINGTON — A new continuing-education program offered by a national pharmacist professional organization aims to prepare pharmacists to communicate with patients about the safe and effective use of the painkiller acetaminophen.

The American Pharmacists Association said its new CE program would allow pharmacists to outline the Food and Drug Administration's recent advisory panel meetings on the drug, communicate with patients about its appropriate use, and engage consumers in dialogue and such activities as reading labels of products containing acetaminophen.

MORRISTOWN, N.J. — Actavis is in the process of bringing FeverAll acetaminophen suppositories back to the market, the company announced. FeverAll had been unavailable while changes were being made at the product's manufacturing facility.

PALM BEACH GARDENS, Fla. — AccuDial Pharmaceutical on Tuesday acquired Stephen Key Design in a move that will expand AccuDial’s patent portfolio to more than 50 patents for weight-based dosing and other extended content rotating labels, which add 75% more labeling space to a container.

IRVINGTON, N.Y. — Prestige Brands on Thursday announced the launch of its new PediaCare and Little Remedies single-concentration acetaminophen products.

The new standard concentration liquid acetaminophen products for infants and children under 2 years of age will be 160 mg/5 mL.

“The voluntary changes to single-concentration acetaminophen dosing demonstrate the continued commitment to accuracy, safety and innovation from PediaCare and Little Remedies," Prestige VP over-the-counter products Albert Hwang said.

ROCKVILLE, Md. — The Food and Drug Administration on Friday refreshed its Consumer Updates page with information regarding the danger of acetaminophen overdose in children.

“You’re in the drug store, looking for a fever-reducing medicine for your children,” the message begins. “They range in age from 6 months to 7 years, and you want to buy one product you can use for all of them. So you buy liquid acetaminophen in concentrated drops for infants, figuring you can use the dropper for the baby and a teaspoon for the oldest.”