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March 13, 2014

Using azithromycin and levofloxacin increases the risk of cardiac arrhythmia and death, according to a study of U.S. veterans.

COLUMBIA, S.C. — Using azithromycin and levofloxacin increases the risk of cardiac arrhythmia and death, according to a study of U.S. veterans.

The research was published in the March/April issue of Annals of Family Medicine.

March 7, 2014

It's finally happening. Pfizer has placed the ball at the line of scrimmage. And based on the X's and O's to come out of its Lipitor OTC actual-use study, Pfizer will be making its run with its eye on the ultimate prize — a successful Rx-to-OTC switch of a statin.

Only this time, the Food and Drug Administration may not be as quick to sack Pfizer's switch attempt. With the advances and pervasion of health technology in the self-care space by way of smartphones and tablets; with the evolution of the pharmacist as a healthcare professional able to practice at the top of their license; and with the adoption of diagnostic tests like a cholesterol panel that can be physically administered in the pharmacy, consumers may finally get it right when self-selecting a statin.

Because it's the consumer actual-use studies that have scuttled just about every statin switch attempt in the past. In the last switch of Mevacor, FDA advisory panelists determined the statin was safe enough for the self-care space. And it was effective. It's just that the consumers who would be right for an OTC statin didn't appropriately self-select. And if they can't appropriately self-select, what's the point, really?

It's finally happening. Pfizer has placed the ball at the line of scrimmage. And based on the X's and O's to come out of its Lipitor OTC actual-use study, Pfizer will be making its run with its eye on the ultimate prize — a successful Rx-to-OTC switch of a statin. 

March 6, 2014

Lupin on Thursday announced that it received final approval from the Food and Drug Administration for both its doxycycline capsules and its ciprofloxacin for oral suspension.

MUMBAI and BALTIMORE — Lupin on Thursday announced that it received final approval from the Food and Drug Administration for its doxycycline capsules USP, 50 mg, 75 mg and 100 mg, which is the generic version of Aqua Pharmaceuticals' Monodox capsules. The drug is used to treat infections caused by various microorganisms and as an adjunctive therapy in severe acne, according to the company.

March 6, 2014

McNeil Consumer Healthcare on Wednesday introduced a new form to the Zyrtec portfolio of allergy-relief products — an oral, dissolvable tablet.

FORT WASHINGTON, Pa. — McNeil Consumer Healthcare on Wednesday introduced a new form to the Zyrtec portfolio of allergy-relief products — an oral, dissolvable tablet. Delivering the same effective 24-hour relief, Zyrtec Dissolve Tabs are now available at all major retailers and pharmacies.

Zyrtec, the best-selling brand within the cold-allergy-sinus tablet category, generated $317.3 million for the 52 weeks ended Dec. 29, up 1.8% across total U.S. multi-outlet, according to IRI data. 

March 5, 2014

Most people who abuse prescription opioid drugs get them for free from a friend or relative — but those at highest risk of overdose are as likely to get them from a doctor’s prescription, Centers for Disease Control researchers reported Monday in a research letter, “Sources of Prescription Opioid Pain Relievers by Frequency of Past-Year Nonmedical Use: United States, 2008-2011,” in the Journal of the American Medical Association Internal Medicine.

ATLANTA — Most people who abuse prescription opioid drugs get them for free from a friend or relative — but those at highest risk of overdose are as likely to get them from a doctor’s prescription, Centers for Disease Control researchers reported Monday in a research letter, “Sources of Prescription Opioid Pain Relievers by Frequency of Past-Year Nonmedical Use: United States, 2008-2011,” in the Journal of the American Medical Association Internal Medicine.

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.  

March 5, 2014

Dr. Reddy's Labs announced the launch of moxifloxacin hydrochloride tablets — the generic version of Avelox tablets — in 400-mg form.

HYDERABAD, India — Dr. Reddy's Labs announced the launch of moxifloxacin hydrochloride tablets, the generic version of Avelox tablets, in 400-mg form. The drug is available in bottle counts of 30.

Avelox tablets had U.S. sales of approximately $195 million for the 12 months ending in December 2013, according to IMS Health.

 

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.

March 3, 2014

Teva Pharmaceutical Industries announced the launch of Adasuve (loxapine) inhalation powder in a 10-mg dosage. The drug is the first and only orally inhaled medicine for the acute treatment of agitation associated with schizophrenia or bipolar disorder in adults.

JERUSALEM — Teva Pharmaceutical Industries announced the launch of Adasuve (loxapine) inhalation powder in a 10-mg dosage. The drug is the first and only orally inhaled medicine for the acute treatment of agitation associated with schizophrenia or bipolar disorder in adults.

March 3, 2014

Pfizer is recruiting for a 1,200-patient actual use study to measure whether or not patients can appropriately self-select treating high cholesterol with the statin Lipitor, the Wall Street Journal reported on Sunday.

NEW YORK — Pfizer is recruiting for a 1,200-patient actual use study to measure whether or not patients can appropriately self-select treating high cholesterol with the statin Lipitor, the Wall Street Journal reported on Sunday. 

The trial is recruiting patients through more than 35 pharmacies and is expected to be completed by year-end.  

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 20, 2014

Kremers Urban Pharmaceuticals announced the launch of rabeprazole sodium delayed-release tablets, which are used to treat gastroesophageal reflux disease in adults and adolescents.

PRINCETON, N.J. — Kremers Urban Pharmaceuticals, a subsidiary of UCB, announced the launch of rabeprazole sodium delayed-release tablets. The drug is used to treat gastroesophageal reflux disease in adults and adolescents, according to the FDA.

The product is the bioequivalent to Aciphex from Eisai. Kremers Urban rabeprazole sodium delayed-release tablets are available in 20-mg strength in both 30- and 90-count bottles.

February 20, 2014

Comedian Larry the Cable Guy has teamed up with Prilosec OTC to show racing fans that “You Can’t Beat Zero” by offering them great “Zero Experiences” at two top stock car races and a chance at winning Prilosec OTC’s hottest wheels: a “monster” utility vehicle.

CINCINNATI — Comedian Larry the Cable Guy has teamed up with Prilosec OTC to show racing fans that “You Can’t Beat Zero” by offering them great “Zero Experiences” at two top stock car races and a chance at winning Prilosec OTC’s hottest wheels: a “monster” utility vehicle.

February 20, 2014

Teva Pharmaceuticals announced the introduction of moxifloxacin hydrochloride tablets, the generic equivalent to Avelox tablets.

NORTH WALES, Pa. — Teva Pharmaceuticals announced the introduction of moxifloxacin hydrochloride tablets, the generic equivalent to Avelox tablets. The drug is available in 400-mg strength.

Moxifloxacin hydrochloride is used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria, the company said.

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.

February 13, 2014

After meeting for two days earlier this week, the Food and Drug Administration's Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 16-9 against changing the label of naproxen to highlight a lower cardiovascular risk profile as compared to other NSAIDs, according to published reports.

SILVER SPRING, Md. — After meeting for two days earlier this week, the Food and Drug Administration's Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 16-9 against changing the label of naproxen to highlight a lower cardiovascular risk profile as compared to other NSAIDs, according to published reports. 

Those advisory panels who voted against the change felt the data were insufficient to say naproxen was safer than other NSAIDs.

February 12, 2014

Mallinckrodt and Cadence Pharmaceuticals on Tuesday announced that they have entered into a definitive agreement under which a subsidiary of Mallinckrodt will commence a tender offer to acquire all outstanding shares of Cadence Pharmaceuticals for $14.00 per share in cash.

DUBLIN — Mallinckrodt and Cadence Pharmaceuticals on Tuesday announced that they have entered into a definitive agreement under which a subsidiary of Mallinckrodt will commence a tender offer to acquire all outstanding shares of Cadence Pharmaceuticals for $14.00 per share in cash or approximately $1.3 billion on a fully diluted basis, which represents a 32% premium to the trailing 30-trading-day volume weighted average price of $10.62 per share for Cadence Pharmaceuticals.

February 7, 2014

The January/February 2014 Vitamins and Supplements Ingredient Guide breaks down the indication, ingredients, purpose and dosage of Vitamints Immune, Centrum Specialist Immune Support, Alive! Children's Multi-Vitamin Gummy, Natrol's Melatonin, VitaMelts Multi, TruBiotics, Align and Culturelle Digestive Health Capsules.

The January/February 2014 Vitamins and Supplements Ingredient Guide breaks down the indication, ingredients, purpose and dosage of Vitamints Immune, Centrum Specialist Immune Support, Alive! Children's Multi-Vitamin Gummy, Natrol's Melatonin, VitaMelts Multi, TruBiotics, Align and Culturelle Digestive Health Capsules.

January 24, 2014

Hi-Tech Pharmacal Co., a specialty pharmaceuticals company, announced that it was granted final approval from the Food and Drug Administration for bromfenac ophthalmic solution 0.09% (once-a-day).

AMITYVILLE, N.Y. — Hi-Tech Pharmacal Co., a specialty pharmaceuticals company, on Thursday announced that it was granted final approval from the Food and Drug Administration for bromfenac ophthalmic solution 0.09% (once-a-day), a generic version of ISTA Pharmaceuticals’ Bromday ophthalmic solution, 0.09%.

The product is used to treat post-op inflammation and reduction of ocular pain in patients who have had cataract surgery. The company plans to launch the product immediately.

January 24, 2014

Perrigo announced that it received final approval from the Food and Drug Administration for repaglinide tablets — a generic version of Prandin tablets.

DUBLIN — Perrigo Co. announced that it received final approval from the Food and Drug Administration for repaglinide tablets — a generic version of Prandin tablets — in 1-mg and 2-mg strengths. The company has started shipment of the drug. Perrigo previously launched the 0.5-mg strength in 2013.

January 23, 2014

Assembly Member Richard Bloom, D-Santa Monica, introduced legislation that would authorize a pharmacist to dispense the narcotic antagonist naloxone hydrochloride without a prescription in California.

SACRAMENTO, Calif. — Assembly Member Richard Bloom, D-Santa Monica, on Tuesday introduced legislation that would authorize a pharmacist to dispense the narcotic antagonist naloxone hydrochloride without a prescription in California. 

Naloxone is used to treat overdoses of narcotic medications including morphine, codeine and oxycodone and works by reversing the side effects of the narcotic, such as sedation and decreased breathing rate.

January 23, 2014

Mylan announced that its U.S.-based subsidiary has launched repaglinide tablets, a generic version of Novo Nordisk's Prandin.

PITTSBURGH — Mylan on Thursday announced that its subsidiary has launched repaglinide tablets, a generic version of Novo Nordisk's Prandin. The drug is used to improve glycemic control in adults with Type 2 diabetes mellitus.

Repaglinide tablets in 0.5 mg, 1 mg and 2 mg had sales in the United States of approximately $212.95 million for the 12 months ending Sept. 30, 2013, according to IMS Health.

 

January 22, 2014

Takeda Pharmaceuticals and Lundbeck announced the availability of Brintellix (vortioxetine), a once-daily oral antidepressant for treatment of major depressive disorder in adults.

DEERFIELD, Ill. — Takeda Pharmaceuticals U.S.A. and Lundbeck on Tuesday announced the availability of Brintellix (vortioxetine) — a once-daily oral antidepressant for treatment of major depressive disorder in adults — in pharmacies across the United States.

“MDD continues to be a challenging condition to manage, and we are proud to make Brintellix available as a new treatment option for people struggling with major depression,” said Douglas Cole, president of Takeda Pharmaceuticals U.S.A.

January 21, 2014

Vivus and Auxilium Pharmaceuticals announced that the Food and Drug Administration has accepted a supplemental application that proposes to revise the Stendra (avanafil) prescribing information with efficacy and safety information from Study TA-501, entitled "A Randomized, Double-Blind, Placebo-Controlled Evaluation of Avanafil for On-Demand Treatment of Men with Erectile Dysfunction."

MOUNTAIN VIEW, Calif. — Vivus and Auxilium Pharmaceuticals on Tuesday announced that the Food and Drug Administration has accepted a supplemental application that proposes to revise the Stendra (avanafil) prescribing information with efficacy and safety information from Study TA-501, entitled "A Randomized, Double-Blind, Placebo-Controlled Evaluation of Avanafil for On-Demand Treatment of Men with Erectile Dysfunction." 

The PDUFA date for the supplemental filing is Sept. 20, 2014.

January 10, 2014

The Food and Drug Administraiton has approved a liquid formulation of an HIV drug made by Merck, the company said.

WHITEHOUSE STATION, N.J. — The Food and Drug Administraiton has approved a liquid formulation of an HIV drug made by Merck, the company said.

Merck announced the approval of Isentress (raltegravir) for oral suspension, aimed at small children with HIV. The drug may be used by patients as young as four weeks, and the full line of formulations of Isentress now includes the orlal suspension, as well as chewable tablets and film--coated tablets. The company plans to launch the oral suspension in the third quarter of this year.