Content about Combination drugs

April 15, 2014

Greenstone, a generic pharmaceutical subsidiary of Pfizer, announced the introduction of amlodipine besylate/atorvastatin calcium tablets to its roster of products.

PEAPACK, N.J. — Greenstone, a generic pharmaceutical subsidiary of Pfizer, announced the introduction of amlodipine besylate/atorvastatin calcium tablets to its roster of products. The drug is the authorized generic versions of Caduet.

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.

March 5, 2014

In what could turn into a significant change of how retail pharmacy supplies hydrocodone combination products, the Drug Enforcement Administration last week published in the Federal Register a Notice of Proposed Rulemaking to move HCPs from Schedule III to Schedule II, as recommended by the assistant secretary for health of the Department of Health and Human Services and as supported by the DEA’s evaluation of relevant data.

WASHINGTON — In what could turn into a significant change of how retail pharmacy supplies hydrocodone combination products, the Drug Enforcement Administration last week published in the Federal Register a Notice of Proposed Rulemaking to move HCPs from Schedule III to Schedule II, as recommended by the assistant secretary for Health of the department of Health and Human Services and as supported by the DEA’s evaluation of relevant data.  

February 18, 2014

This year, ECRM celebrates 20 years of successfully pairing buyers and sellers across the consumer packaged goods industry.

This year, ECRM celebrates 20 years of successfully pairing buyers and sellers across the consumer packaged goods industry. As part of that celebration, and in correlation to the ECRM Cough-Cold, Analgesics and Allergy event, DSN editors thought it’d be a good idea to look back through the last 20 years of the cough-cold business at retail.

January 30, 2014

Novartis Consumer Health will be relaunching Theraflu for the 2014-2015 cough-cold season, Brian McNamara, Novartis division head OTC, told analysts.

BASEL, Switzerland — Novartis Consumer Health will be relaunching Theraflu for the 2014-2015 cough-cold season, Brian McNamara, Novartis division head OTC, told analysts Wednesday. 

"As you know, in the U.S. business we launched Lamisil and Triaminic and Excedrin end of 2012 and 2013. About halfway through the year, we launched Benefiber. And for next year, we expect to launch Theraflu for that cough and cold season," he said. 

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 8, 2014

News stories about doctor shopping and prescription pad pilfering in pursuit of a pain-pill induced high have become commonplace, prompting many legislators and regulators to consider further restrictions on pain medicines like hydrocodone compounds. But there may be a story that’s not being told — that the patients who suffer from chronic pain and need that hydrocodone to reclaim their lives are being stigmatized. The prevalence of pain pill abuse has left in its wake as many as 116 million legitimate pain sufferers who are finding it more difficult to access their therapies.

NEW YORK — News stories about doctor shopping and prescription pad pilfering in pursuit of a pain-pill induced high have become commonplace, prompting many legislators and regulators to consider further restrictions on pain medicines like hydrocodone compounds.

December 18, 2013

A new study has found a significant increase in the number of high school students who report having abused a common prescription drug for attention deficit hyperactivity disorder, even as abuse of other prescription drugs has decreased or remained low.

NEW YORK — A new study has found a significant increase in the number of high school students who report having abused a common prescription drug for attention deficit hyperactivity disorder, even as abuse of other prescription drugs has decreased or remained low.

December 2, 2013

Sandoz will market an authorized generic version of an attention deficit hyperactivity disorder drug made by Shire under a contract between the two companies, Shire said Monday.

PHILADELPHIA — Sandoz will market an authorized generic version of an attention deficit hyperactivity disorder drug made by Shire under a contract between the two companies, Shire said Monday.

Shire said Sandoz, the generics division of Swiss drug maker Novartis, would market an authorized generic version of Adderall XR (amphetamine; dextroamphetamine).

November 26, 2013

The Food and Drug Administration has accepted Purdue Pharma's regulatory approval application for a new opioid drug, Purdue said Tuesday.

STAMFORD, Conn. — The Food and Drug Administration has accepted Purdue Pharma's regulatory approval application for a new opioid drug, Purdue said Tuesday.

The drug maker announced the FDA's acceptance of its application for Targiniq (oxycodone hydrochloride; naloxone hydrochloride) controlled-release tablets. The drug combines oxycodone with the opioid agonist nalxone.

November 25, 2013

Pfizer on Monday launched Robitussin Maximum Strength Cough + Congestion DM, a new liquid-filled capsule that helps control cough on-the-go.

MADISON, N.J. — Pfizer on Monday launched Robitussin Maximum Strength Cough + Congestion DM, a new liquid-filled capsule that helps control cough on-the-go. "This formulation not only harnesses the power of Maximum Strength Robitussin cough liquid, but is a convenient option for those hitting the road or boarding a plane this holiday season," the company stated.

The company noted that whether traveling cross country or staying close to home, families can track when cough activity spikes in their local area via the Robitussin COUGHCAST tool. 

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. 

October 29, 2013

Actavis hopes to become the first company to market a generic version of a drug used to treat acne in adolescents and adults, the company said.

DUBLIN — Actavis hopes to become the first company to market a generic version of a drug used to treat acne in adolescents and adults, the company said.

The drug maker announced that it had filed a regulatory approval application with the Food and Drug Administration for a generic version of Acanya (clindamycin phosphate; benzoyl peroxide) gel in the 1.2%/2.5% strength. Acanya is made by Valeant Pharmaceuticals International and Dow Pharmaceutical Sciences and is used to treat acne vulgaris in patients aged 12 and older.

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 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 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.)

September 10, 2013

A new set of guidelines from the Food and Drug Administration could bring a generic version of a respiratory drug made by GlaxoSmithKline closer to reality.

NEW YORK — A new set of guidelines from the Food and Drug Administration could bring a generic version of a respiratory drug made by GlaxoSmithKline closer to reality.

The FDA guidelines, a set of non-binding recommendations released Monday, outline studies that manufacturers can conduct to determine equivalence between GSK's Advair Diskus (fluticasone propionate; salmeterol xinafoate) and generic versions.

August 8, 2013

The coming cough-cold season is difficult to project. On one hand, this year's cough-cold incidence will be going against very strong illness rate numbers from last year. In addition, with both McNeil Consumer and Novartis Consumer supporting the relaunch of a number of cough-cold products, the category is expected to be very promotional this season, a factor that could squeeze margins.

DSN estimates that annualized sales of cold and allergy products through mid-June were up 7.9%, representing almost $570 million in incremental dollars.

What are the chances of that happening again?

July 29, 2013

Actavis is launching new formulations of a drug used to treat tension headaches, the company said Monday.

PARSIPPANY, N.J. — Actavis is launching new formulations of a drug used to treat tension headaches, the company said Monday.

The drug maker announced new formulations for Fioricet (butalbital; acetaminophen; caffeine) capsules and Fioricet with Codeine that reduce the amount of acetaminophen from 325 mg to 300 mg. Actavis said the formulation would provide a safer treatment option for patients.

July 25, 2013

Mylan and Orion Corp. have settled a patent-infringement suit over a drug used to treat Parkinson's disease.

PITTSBURGH — Mylan and Orion Corp. have settled a patent-infringement suit over a drug used to treat Parkinson's disease, Mylan said Thursday.

The generic drug maker had filed with the Food and Drug Administration for a generic version of Orion's Stalevo (carpidopa; levodopa; entacapone) tablets, used to treat idiopathic Parkinson's to substitute for immediate-release carbidopa/levodopa and entacapone administered separately.

July 1, 2013

The Food and Drug Administration has declined to approve a sleeping pill made by Merck & Co., citing issues with dosage.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has declined to approve a sleeping pill made by Merck & Co., citing issues with dosage.

The drug maker said Monday that it received a complete response letter from the FDA concerning the drug suvorexant, for which it is seeking regulatory approval. A complete response letter means that the agency has finished reviewing its approval application, but questions remain that preclude final approval.

March 26, 2013

The National Community Pharmacists Association called for the rejection of a proposal made by Sens. Joe Manchin, D-W.Va., and Mark Kirk, R.-Ill., to reschedule Vicodin and other hydrocodone-containing products from Schedule III to Schedule II of the Controlled Substances Act.

ALEXANDRIA, Va. — The National Community Pharmacists Association last week called for the rejection of a proposal made by Sens. Joe Manchin, D-W.Va., and Mark Kirk, R.-Ill., to reschedule Vicodin and other hydrocodone-containing products from Schedule III to Schedule II of the Controlled Substances Act.

March 8, 2013

With private label across analgesics up an estimated 11.3% to $1.7 billion, retailers are going to need to make some tough decisions as two internal analgesic powerhouses — McNeil's Tylenol and Novartis' Excedrin — make their way back onto market after respective recalls.

With private label across analgesics up an estimated 11.3% to $1.7 billion, retailers are going to need to make some tough decisions as two internal analgesic powerhouses — McNeil's Tylenol and Novartis' Excedrin — make their way back onto market after respective recalls. Within internal analgesic tablets, sales of store brand equivalents were up 15% off of a 2011 base of around $1.2 billion. The branded competition also were benefactors — both Pfizer's Advil and Bayer's Aleve generated more than $50 million in incremental sales on top of 2011 sales.

February 15, 2013

The Food and Drug Administration has approved a generic drug for attention deficit hyperactivity disorder made by Teva Pharmaceutical Industries, the Israeli generic drug maker said.

JERUSALEM — The Food and Drug Administration has approved a generic drug for attention deficit hyperactivity disorder made by Teva Pharmaceutical Industries, the Israeli generic drug maker said.