Content about Chemistry

January 22, 2013

The Food and Drug Administration on Friday approved the distribution of 2 million additional doses of Tamiflu (oseltamivir phosphate) 75 mg that contain an older version of the package insert.

ATLANTA — The Food and Drug Administration on Friday approved the distribution of 2 million additional doses of Tamiflu (oseltamivir phosphate) 75 mg that contain an older version of the package insert.

January 22, 2013

The Food and Drug Administration has approved a generic contraceptive made by Lupin Pharmaceuticals, the drug maker said Tuesday.

BALTIMORE — The Food and Drug Administration has approved a generic contraceptive made by Lupin Pharmaceuticals, the drug maker said Tuesday.

Lupin announced the approval of levonorgestrel and ethinyl estradiol tablets in the 0.1 mg/0.02 mg strength, a generic version of Watson Labs' Lutera.

Lutera had sales of about $103.6 million during the 12-month period that ended in September 2012, according to IMS Health.

January 22, 2013

Perrigo announced that it has begun shipments of over-the-counter nicotine polacrilex mini lozenge USP, 2 mg (mint flavor) and 4 mg (mint flavor), comparable to GlaxoSmithKline's Nicorette mini lozenge.

ALLEGAN, Mich. — Perrigo on Tuesday announced that it has begun shipments of over-the-counter nicotine polacrilex mini lozenge USP, 2 mg (mint flavor) and 4 mg (mint flavor), comparable to GlaxoSmithKline's Nicorette mini lozenge. 

"This launch strengthens Perrigo's leading store brand position in smoking cessation products, which also includes coated and uncoated flavored gums and regular size lozenges," stated Joseph Papa, Perrigo's chairman, president and CEO. 

January 21, 2013

While regulations for biosimilars work their way through the Food and Drug Administration, state governments are already looking at legislation concerning the substitution of biosimilars for their branded counterparts, according to a legal affairs blog focused on the FDA.

NEW YORK — While regulations for biosimilars work their way through the Food and Drug Administration, state governments are already looking at legislation concerning the substitution of biosimilars for their branded counterparts, according to a legal affairs blog focused on the FDA.

In a post Friday on FDA Law Blog, the official blog of the law firm Hyman, Phelps & McNamara, attorney Kurt Karst wrote that several states were laying the groundwork for such legislation, recalling state-level antisubstitution laws targeting generics that were adopted in the 1970s.

January 18, 2013

The Food and Drug Administration is allowing Roche to tap its reserves of the flu drug Tamiflu, according to published reports.

NEW YORK — The Food and Drug Administration is allowing Roche to tap its reserves of the flu drug Tamiflu, according to published reports.

Reuters reported that the Swiss drug maker would start selling its reserve stock of the adult formulation of the drug, whose chemical name is oseltamivir.

The FDA has reported spot shortages of the pediatric formulation of the drug, but has said pharmacists can break open the capsules and dissolve it in liquid to create a substitute. Meanwhile, a shortage of the adult formulation has appeared in Canada.

January 17, 2013

Boehringer Ingelheim Pharmaceuticals has enrolled the first patients in its late-stage trial of a treatment for hepatitis C, the drug maker said Thursday.

RIDGEFIELD, Conn. — Boehringer Ingelheim Pharmaceuticals has enrolled the first patients in its late-stage trial of a treatment for hepatitis C, the drug maker said Thursday.

BI Pharmaceuticals is conducting the "HCVerso" trial of an HCV drug that combines faldaprevir, the experimental compound BI 207127 and ribavirin. The company has established trial sites in more than 25 states.

January 17, 2013

Out of more than 200,000 entries, Procter & Gamble named "William R." of Pennsylvania winner of the ultimate sports pack as part of Wild American Flavor Sweepstakes sponsored by Prilosec OTC Wildberry.

CINCINNATI — Out of more than 200,000 entries, Procter & Gamble named "William R." of Pennsylvania winner of the ultimate sports pack as part of Wild American Flavor Sweepstakes sponsored by Prilosec OTC Wildberry.

The contestant won a once-in-a-lifetime trip to three of the country’s "most flavorful" cities that host the biggest sporting events in America, including tickets to the Super Bowl, NASCAR's Daytona 500 and the NCAA basketball championship game in Atlanta, travel and accommodations and $5,000. 

January 16, 2013

New York is hoping to battle the theft of highly addictive prescription drugs, such as Oxycontin, by stocking pharmacies with fake pill bottles that are fitted with GPS tracking devices, according to published reports.

NEW YORK — New York is hoping to battle the theft of highly addictive prescription drugs, such as Oxycontin, by stocking pharmacies with fake pill bottles that are fitted with GPS tracking devices, according to published reports.

The Washington Post reported that Police Commissioner Raymond Kelly said, in prepared remarks provided before a conference Tuesday in California sponsored by former president Bill Clinton’s foundation, that the initiative was sparked by a series of crimes associated with the black market for prescription painkillers.

January 15, 2013

Lifes2good Natural Healthcare recently announced the introduction of a pair of new hair growth supplements: Viviscal Extra Strength and Viviscal Man.

CHICAGO — Lifes2good Natural Healthcare recently announced the introduction of a pair of new hair growth supplements: Viviscal Extra Strength and Viviscal Man. 

The new extra-strength formulation contains 50% more of the active ingredient AminoMar, a proprietary blend of ingredients and proteins said to promote existing hair growth. It also contains new ingredients biotin, iron and zinc.  

January 15, 2013

Drug maker Otsuka Pharmaceuticals can keep generic versions of its schizophrenia drug off the market, according to published reports.

NEW YORK — Drug maker Otsuka Pharmaceuticals can keep generic versions of its schizophrenia drug off the market, according to published reports.

Bloomberg reported that the Supreme Court upheld a ruling that allowed Otsuka to block Canadian generic drug maker Apotex from marketing a version of the antipsychotic Abilify (aripiprazole), which Otsuka co-markets with Bristol-Myers Squibb.

January 15, 2013

A maker of drugs for epilepsy has appointed a new executive.

ROCKVILLE, Md. — A maker of drugs for epilepsy has appointed a new executive.

Supernus Pharmaceuticals announced the appointment of Victor Vaughn as SVP sales, a position in which he will be responsible for leading all the company's sales activities.

January 15, 2013

While replacing a single combination pill for HIV with generics would save the healthcare system money, it could also diminish the effectiveness of treatment, a new study suggests.

NEW YORK — While replacing a single combination pill for HIV with generics would save the healthcare system money, it could also diminish the effectiveness of treatment, a new study suggests.

The study, led by investigators at the Massachusetts General Hospital and Weill Cornell Medical College, and published in the Jan. 15 issue of Annals of Internal Medicine, found $1 billion in potential savings, but the more complicated treatment regimen might result in more patients missing doses and a loss of drug effectiveness.

January 14, 2013

As if the reported spot shortages of flu vaccine aren't bad enough, there have been reports of similar shortages of flu drugs throughout the United States and parts of Canada due to increased demand.

As if the reported spot shortages of flu vaccine aren't bad enough, there have been reports of similar shortages of flu drugs throughout the United States and parts of Canada due to increased demand.

January 10, 2013

The Food and Drug Administration is ordering the makers of several sleep drugs to lower the dosage due to the risk that they can impair patients the morning after, the agency said Thursday.

SILVER SPRING, Md. — The Food and Drug Administration is ordering the makers of several sleep drugs to lower the recommended dosage due to the risk that they can impair patients the morning after, the agency said Thursday.

The FDA announced that it was requiring the manufacturers of drugs containing the active ingredient zolpidem to lower the current recommended dosage in light of new data showing that the morning after use, the drug can remain in the blood in sufficient quantities to impair activities that require alertness, such as driving.

January 9, 2013

One of the most serious drug abuse problems in the country doesn't involve heroin, methamphetamine or crack, but abuse of legal prescription drugs, particularly opioid painkillers, a problem that the Food and Drug Administration aims to change with draft guidance released Wednesday.

SILVER SPRING, Md. — One of the most serious drug abuse problems in the country doesn't involve heroin, methamphetamine or crack, but abuse of legal prescription drugs, particularly opioid painkillers, a problem that the Food and Drug Administration aims to change with draft guidance released Wednesday.

January 8, 2013

The Council for Responsible Nutrition on Tuesday announced the addition of eight new members, including voting members Church & Dwight and P.J. Noyes Co., along with associate members AIBMR Life Sciences, Bell Advisory Services, Biofortis, Creative Flavor Concepts and Nutrasource Diagnostics.

WASHINGTON — The Council for Responsible Nutrition on Tuesday announced the addition of eight new members, including voting members Church & Dwight and P.J. Noyes Co., along with associate members AIBMR Life Sciences, Bell Advisory Services, Biofortis, Creative Flavor Concepts and Nutrasource Diagnostics.

January 8, 2013

Select Family Dollar Stores will carry an environmentally friendly, individually-sold 3-lb firelog by Enviro-Log, the company stated.

ATLANTA — Select Family Dollar Stores will carry an environmentally friendly, individually-sold 3-lb firelog by Enviro-Log, the company stated.

"Family Dollar customers will appreciate the convenience and performance of our 3-lb firelogs, which burn cleaner and hotter than firewood," said Ross McRoy, president of Enviro-Log. "We are thrilled that Family Dollar customers can now take advantage of these environmentally friendly firelogs, as each Enviro-Log provides warmth and comfort for hours at a time."

January 7, 2013

Drug maker Prasco Labs has launched an authorized generic version of a drug used to treat heavy menstrual bleeding, the company said.

CINCINNATI, Ohio — Drug maker Prasco Labs has launched an authorized generic version of a drug used to treat heavy menstrual bleeding, the company said Monday.

Prasco announced the launch of tranexamic acid tablets in the 650 mg strength, an authorized generic version of Ferring Pharmaceuticals' Lysteda. Authorized generics are branded drugs marketed under their generic names at a discount, usually through third-party companies, to compete with Food and Drug Administration-approved generics.

January 3, 2013

Murad has announced the launch of Rapid Collagen Infusion, a multi-tasking formula that is designed to fight wrinkles and loss of resilience by promoting collagen and elastin production while maintaining healthy hydration levels in the skin.

EL SEGUNDO, Calif. — Murad has announced the launch of Rapid Collagen Infusion, a multi-tasking formula that is designed to fight wrinkles and loss of resilience by promoting collagen and elastin production while maintaining healthy hydration levels in the skin.

Rapid Collagen Infusion, which is part of the company’s Age Reform line, is clinically proven to reduce the appearance of fine lines and wrinkles in two hours, according to the company.

January 3, 2013

A court has ruled in favor of Indian generic drug maker Ranbaxy Labs in a case concerning a generic blood pressure drug, the legal firm representing the drug maker said.

WASHINGTON — A court has ruled in favor of Indian generic drug maker Ranbaxy Labs in a case concerning a generic blood pressure drug, the legal firm representing the drug maker said.

Zuckerman Spaeder LLP said the U.S. District Court for the District of Columbia upheld a Food and Drug Administration decision protecting Ranbaxy's market exclusivity for a generic version of Novartis' drug Diovan (valsartan).

January 2, 2013

The Food and Drug Administration last week approved the anti-clotting drug Eliquis (apixaban), an oral tablet used to reduce the risk of stroke and dangerous blood clots in patients with atrial fibrillation that is not caused by a heart valve problem. Eliquis is manufactured by Bristol-Myers Squibb, and marketed by BMS and Pfizer.

PRINCETON, N.J. — The Food and Drug Administration last week approved the anti-clotting drug Eliquis (apixaban), an oral tablet used to reduce the risk of stroke and dangerous blood clots in patients with atrial fibrillation that is not caused by a heart valve problem. Eliquis is manufactured by Bristol-Myers Squibb, and marketed by BMS and Pfizer.

January 2, 2013

The U.S. Food and Drug Administration on Monday approved Fulyzaq (crofelemer) to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy, a combination of medicines used to treat HIV infection.

SPRING SPRING, Md. — The U.S. Food and Drug Administration on Monday approved Fulyzaq (crofelemer) to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy, a combination of medicines used to treat HIV infection. Diarrhea is experienced by many HIV/AIDS patients and is a common reason why patients discontinue or switch their antiretroviral therapies.

January 2, 2013

Zak Designs is looking to expand its environmental commitment by launching a new line of dinnerware, serveware and kitchen prep items, all made from recycled melamine.

SPOKANE, Wash. — Zak Designs is looking to expand its environmental commitment by launching a new line of dinnerware, serveware and kitchen prep items, all made from recycled melamine. The Sprinkles collection uses the same patented process Zak used in its best-selling, upscale Confetti collection, allowing the company to offer the same environmentally friendly products to the mass market.

December 28, 2012

Teva Pharmaceuticals has received approval of their new drug application for topotecan hydrochloride injection, a treatment for small cell lung cancer, according to Food and Drug Administration records.

SILVER SPRINGS, Md. — Teva Pharmaceuticals has received approval of their new drug application for topotecan hydrochloride injection, a treatment for small cell lung cancer, according to Food and Drug Administration records.

December 28, 2012

A federal judge in Washington has dismissed a suit against the FDA brought up by Mylan for withholding approval for the company to sell a generic version of Novartis AG’s heart pill, Diovan.

WASHINGTON — A federal judge in Washington has dismissed a suit against the FDA brought up by Mylan for withholding approval for the company to sell a generic version of Novartis AG’s heart pill, Diovan.

U.S. District Court Judge John D. Bates said in an opinion filed on Dec. 27, that the FDA did not act “capriciously” when it denied Mylan exclusivity to market its version of Diovan. Bates also said Mylan did not show it suffered “irreparable harm” as a result.