Content about Phenols

April 4, 2014

The National Association of Boards of Pharmacy recommended that pharmacies no longer dispense combination drugs containing more than 325 mg of acetaminophen per dosage unit in light of recent regulatory action.

MOUNT PROSPECT, Ill. — The National Association of Boards of Pharmacy on Wednesday recommended that pharmacies no longer dispense combination drugs containing more than 325 mg of acetaminophen per dosage unit in light of recent regulatory action.  

NABP also advises that pharmacists consult with prescribers to discuss alternative products with lower acetaminophen doses.

April 1, 2014

Prasco Labs on Tuesday announced that it has signed a marketing and distribution agreement with Eli Lilly and Co. to market the authorized generic version of Evista (raloxifene hydrochloride tablets), 60 mg strength, in the United States.

CINCINNATI — Prasco Labs on Tuesday announced that it has signed a marketing and distribution agreement with Eli Lilly and Co. to market the authorized generic version of Evista (raloxifene hydrochloride tablets), 60 mg strength, in the United States.

April 1, 2014

Teva Pharmaceuticals on Tuesday announced the introduction and availability of Raloxifene hydrochloride tablets, USP.

JERUSALEM — Teva Pharmaceuticals on Tuesday announced the introduction and availability of Raloxifene hydrochloride tablets, USP. This product is AB rated and bioequivalent to Evista tablets.  

Raloxifene hydrochloride tablets, USP are indicated for the treatment and prevention of osteoporosis in postmenopausal women. 

Teva was first to file, making the product eligible for 180 days of marketing exclusivity.

March 20, 2014

Purdue Pharma recently announced that a Phase 3 study of an investigational extended‐release formulation of hydrocodone bitartrate met its primary efficacy endpoint by showing that patients with chronic low back pain treated with the once‐daily analgesic agent experienced statistically significant reduction in pain compared with placebo.

STAMFORD, Conn. — Purdue Pharma recently announced that a Phase 3 study of an investigational extended‐release formulation of hydrocodone bitartrate met its primary efficacy endpoint by showing that patients with chronic low back pain treated with the once‐daily analgesic agent experienced statistically significant reduction in pain compared with placebo. 

March 18, 2014

Mallinckrodt Plc last week announced that the Food and Drug Administration approved Xartemis XR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets (CII), for the management of acute pain severe enough that it requires opioid treatment.

DUBLIN — Mallinckrodt Plc last week announced that the Food and Drug Administration approved Xartemis XR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets (CII), for the management of acute pain severe enough that it requires opioid treatment.

The drug also is indicated for patients for whom alternative treatments have shown to be ineffective. Xartemis XR, previously known as MNK-795, is the first and only extended-release oral combination of two clinically proven pain medications — oxycodone and acetaminophen.

March 4, 2014

Teva Pharmaceutical Industries announced that it received approval for generic Evista (raloxifene) tablets, 60-mg, in the United States.

JERUSALEM — Teva Pharmaceutical Industries on Tuesday announced that it received approval for generic Evista (raloxifene) tablets, 60-mg, in the United States. The company was the first to file, which means the product is eligible for 180 days of marketing exclusivity. Teva will begin shipping the drug within the next 30 days.

Evista 60-mg tablets, marketed by Eli Lilly and Co., had annual sales in the United States of approximately $824 million as of December 2013, according to IMS data. The drug is used to prevent and treat osteoporosis in postmenopausal women.

February 25, 2014

New research released Tuesday found that when it comes to treating pain, a growing number of consumers know how to safely use medicines with acetaminophen and to avoid accidental overdose and liver damage.

WASHINGTON — New research released Tuesday found that when it comes to treating pain, a growing number of consumers know how to safely use medicines with acetaminophen and to avoid accidental overdose and liver damage. A nationwide consumer survey conducted by the Consumer Healthcare Products Association Educational Foundation, in conjunction with its work on the Acetaminophen Awareness Coalition’s Know Your Dose educational campaign, shows that consumer safe use knowledge and risk awareness has increased over a three year period (2010-2013).

February 24, 2014

Concurrent opioid prescribing by multiple providers is common in Medicare patients and is associated with higher rates of hospital admission related to opioid use, according to a study published last week in BMJ.

LONDON — Concurrent opioid prescribing by multiple providers is common in Medicare patients and is associated with higher rates of hospital admission related to opioid use, according to a study published last week in BMJ

February 18, 2014

Sun Pharmaceutical Industries announced that the Food and Drug Administration has granted final approval for its generic version of Temodar temozolomide capsules in 5-mg, 20-mg, 100-mg 140-mg, 180-mg and 250-mg form.

MUMBAI — Sun Pharmaceutical Industries announced that the Food and Drug Administration has granted final approval for its generic version of Temodar temozolomide capsules in 5-mg, 20-mg, 100-mg 140-mg, 180-mg and 250-mg form.

January 17, 2014

The Consumer Healthcare Products Association responded to the Food and Drug Administration’s recommendation to discontinue prescribing and dispensing prescription combination medicines that contain more than 325 mg of acetaminophen per dosage unit, suggesting it would not impact use of over-the-counter formulations containing acetaminophen.

WASHINGTON — The Consumer Healthcare Products Association on Thursday responded to the Food and Drug Administration’s recommendation to discontinue prescribing and dispensing prescription combination medicines that contain more than 325 mg of acetaminophen per dosage unit, suggesting it would not impact use of over-the-counter formulations containing acetaminophen.

January 15, 2014

The Food and Drug Administration recommended healthcare professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 mg of acetaminophen per tablet, capsule or other dosage unit.

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday recommended healthcare professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 mg of acetaminophen per tablet, capsule or other dosage unit. 

January 9, 2014

Mylan has launched a generic drug for preventing rejection of transplanted organs, the company said Thursday.

PITTSBURGH — Mylan has launched a generic drug for preventing rejection of transplanted organs, the company said Thursday.

The generic drug maker announced the launch of mycophenolic acid delayed-release tablets in the 180-mg and 360-mg strengths. The drug is a generic version of Novartis' Myfortic. As the first company to file a completed regulatory approval application for the generic, Mylan is entitled to 180 days in which to compete exclusively against Novartis' product before the Food and Drug Administration can approve additional generic versions.

January 7, 2014

Mylan has launched a generic version of a drug made by Pfizer for treating bladder problems, the company said Tuesday.

PITTSBURGH — Mylan has launched a generic version of a drug made by Pfizer for treating bladder problems, the company said Tuesday.

Mylan announced the launch of tolterodine tartrate extended-release capsules in the 2-mg and 4-mg strengths. The drug is used to treat overactive bladder with symptoms of urinary incontinence, urgency and frequency.

The drug is a generic version of Pfizer's Detrol LA. Tolterodine tartrate extended-release capsules had sales of about $571.5 million during the 12-month period that ended in September, according to IMS Health.

November 26, 2013

QRxPharma has resubmitted its regulatory approval application for an opioid painkiller for which it has sought Food and Drug Administration approval since 2011, the company said Tuesday.

BEDMINSTER, N.J. — QRxPharma has resubmitted its regulatory approval application for an opioid painkiller for which it has sought Food and Drug Administration approval since 2011, the company said Tuesday.

The Australian drug maker announced the resubmission of its application for Moxduo, a pill that combines oxycodone and morphine.The FDA is expected to schedule an advisory committee meeting to review the application for May 2014.

November 13, 2013

As cold and flu season kicks into high gear, the Acetaminophen Awareness Coalition on Tuesday issued a nationwide safety message urging consumers to double-check their medicine labels so they don’t double-up on medicines that contain acetaminophen when treating winter illnesses.

WASHINGTON — As cold and flu season kicks into high gear, the Acetaminophen Awareness Coalition on Tuesday issued a nationwide safety message urging consumers to double-check their medicine labels so they don’t double-up on medicines that contain acetaminophen when treating winter illnesses. 

November 5, 2013

The Food and Drug Administration has approved a generic drug made by Mylan for treating overactive bladder, according to agency records.

SILVER SPRING, Md. — The Food and Drug Administration has approved a generic drug made by Mylan for treating overactive bladder, according to agency records.

The FDA approved Mylan's tolterodine tartrate extended-release capsules in the 2-mg and 4-mg strengths.

The drug is a generic version of Pfizer's Detrol LA. Detrol LA has annual sales of about $700 million, according to published reports.

 

November 4, 2013

The Food and Drug Administration has approved a new injectable painkiller made by Becton, Dickinson and Co., the medical products manufacturer said Monday.

FRANKLIN LAKES, N.J. — The Food and Drug Administration has approved a new injectable painkiller made by Becton, Dickinson and Co., the medical products manufacturer said Monday.

BD announced the FDA approval of morphine sulfate injection as part of its BD Simplist line of ready-to-administer pre-filled injectables. The drug was approved in the 2-mg-per-mL, 4-mg-per-mL, 5-mg-per-mL, 8-mg-per-mL and 10-mg-per-mL strengths.

November 4, 2013

Perrigo on Friday initiated a voluntary, nationwide product recall to the retail level of 18 batches of its acetaminophen infant suspension liquid.

ALLEGAN, Mich. —  Perrigo on Friday initiated a voluntary, nationwide product recall to the retail level of 18 batches of its acetaminophen infant suspension liquid, 160 mg/5 mL, sold in 2 oz. and 4 oz. bottles with syringes in a box because of the remote potential that a small number of packages might contain an oral dosing syringe without dose markings. 

October 29, 2013

Actavis had sales of $2.01 billion in third quarter 2013, a 57% increase over the same period last year, the drug maker said Tuesday.

DUBLIN — Actavis had sales of $2.01 billion in third quarter 2013, a 57% increase over the same period last year, the drug maker said Tuesday.

Profits for the quarter were $65.5 million, down from $76.7 million in third quarter 2012. The quarter's results exclude figures from Ireland-based Warner Chilcott, which Actavis acquired at the beginning of the month.

October 25, 2013

The Food and Drug Administration has approved a new opioid painkiller made by Zogenix, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new opioid painkiller made by Zogenix, the agency said Friday.

The FDA announced the approval of Zohydro ER (hydrocodone) extended-release capsules for the management of pain severe enough to require daily, around-the-clock, long-term treatment. The agency said the drug was the first extended-release hydrocodone product not combined with another drug, such as acetaminophen, to be approved by the agency.

October 25, 2013

The Food and Drug Administration plans to recommend stronger regulations for a commonly used opioid painkiller.

SILVER SPRING, Md. — The Food and Drug Administration plans to recommend stronger regulations for a commonly used opioid painkiller.

October 25, 2013

The Food and Drug Administration plans to officially recommend that products containing 15 mg or less of the opioid painkiller hydrocodone be rescheduled as Schedule II controlled substances, from the current Schedule III classification. While the idea is to combat abuse and misuse of the drugs, pharmacy groups say the rescheduling would make them harder to obtain for patients who legitimately need them.

The desire to combat abuse and misuse of prescription drugs — now a worse problem in the United States than cocaine or heroin — is laudable, but unlike those two drugs, hydrocodone has a legitimate use as a painkiller, and it's the people who are using it properly and legally who will end up losing.

The Food and Drug Administration plans to officially recommend that products containing 15 mg or less of the opioid painkiller hydrocodone be rescheduled as Schedule II controlled substances, from the current Schedule III classification. While the idea is to combat abuse and misuse of the drugs, pharmacy groups say the rescheduling would make them harder to obtain for patients who legitimately need them.

October 21, 2013

The Food and Drug Administration has approved a pain drug made by Iroko Pharmaceuticals, Iroko said.

PHILADELPHIA — The Food and Drug Administration has approved a pain drug made by Iroko Pharmaceuticals, Iroko said.

The drug maker announced the approval of Zorvolex (diclofenac) capsules for mild to moderate acute pain in adults. The drug is a non-steroidal anti-inflammatory drug, or NSAID, belonging to the same class as the common analgesic drug ibuprofen. Zorvolex was approved at dosage strengths 20% lower than currently available diclofenac products, the company said.

October 11, 2013

The global market for drugs to treat constipation resulting from use of opioid painkillers will increase more than tenfold by 2017, according to new research.

LONDON — The global market for drugs to treat constipation resulting from use of opioid painkillers will increase more than tenfold by 2017, according to new research.

October 10, 2013

Such iconic pain relief brands as McNeil Consumer’s Tylenol and Motrin, and Novartis’ Excedrin, have made their way back to the shelf this fall following a recall-driven hiatus. And the sales have already started to accumulate.

Such iconic pain relief brands as McNeil Consumer’s Tylenol and Motrin, and Novartis’ Excedrin, have made their way back to the shelf this fall following a recall-driven hiatus. And the sales have already started to accumulate.

(For the full category review, including sales data, click here.)