Content about New Drugs & OTCs

November 6, 2012
FDA approves Pfizer rheumatoid arthritis drug

The Food and Drug Administration has approved a drug for rheumatoid arthritis ahead of the day the agency was scheduled to decide whether or not to approve it, the agency said Tuesday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug for rheumatoid arthritis ahead of the day the agency was scheduled to decide whether or not to approve it, the agency said Tuesday.

November 5, 2012
FDA approves J&J anti-clotting drug

The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating internal blood clots, the company said.

RARITAN, N.J. — The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating internal blood clots, the company said.

J&J subsidiary Janssen Pharmaceuticals announced the approval of Xarelto (rivaroxaban) for treating deep-vein thrombosis and pulmonary embolism and to reduce the risk of recurrence of the clotting conditions after initial treatment.

The company said Xarelto was the first oral anticoagulant approved to treat DVT and PE without the need for injections or routine blood-monitoring.

November 2, 2012
Emerson Ecologics, Douglas Labs partner on line of professional, NSF-certified sports supplements

Emerson Ecologics, a provider of professional-grade nutritional supplements to practitioners, on Thursday announced its partnership with Douglas Laboratories as its exclusive external distributor for the Klean Athlete line to healthcare practitioners.

MANCHESTER, N.H. — Emerson Ecologics, a provider of professional-grade nutritional supplements to practitioners, on Thursday announced its partnership with Douglas Laboratories as its exclusive external distributor for the Klean Athlete line to healthcare practitioners. 

Klean Athlete is a new line of nutritional supplements formulated specifically for athletes to help them achieve optimum health; the complete line is NSF-certified for sport, ensuring that each product has undergone testing and certification to be free of banned substances.

November 1, 2012
Lil' Drug Store Products adds fertility-friendly personal lubricant to its women's health lineup

Lil’ Drug Store Products on Thursday announced the purchase of the Pre-Seed brand of feminine lubricant from BioOrigyn.

CEDAR RAPIDS, Iowa — Lil’ Drug Store Products on Thursday announced the purchase of the Pre-Seed brand of feminine lubricant from BioOrigyn.

October 31, 2012
Perfecta Products expands distribution of Zim's Maximum Heat

Perfecta Products on Wednesday announced expansion of its Zim's Maximum Heat external analgesic.

NORTH LIMA, Ohio — Perfecta Products on Wednesday announced expansion of its Zim's Maximum Heat external analgesic.

Maximum Heat is indicated for the temporary relief of muscle, back, shoulder and neck pain. It is the sister product of Perfecta's Zim's Max-Freeze. Zim's Maximum Heat is formulated with aloe, arnica, vitamin E and tea tree oil.

Both the 2.5-oz. Zim's Maximum Heat Roll-On and 3.5-oz. tube of Zim's Maximum Heat retail for a suggested $10.49.

October 26, 2012
FDA approves Teva's Synribo for blood and bone marrow cancer

The Food and Drug Administration has approved what it called the second new drug in two months for a form of leukemia, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved what it called the second new drug in two months for a form of leukemia, the agency said Friday.

The FDA announced the approval of Teva Pharmaceutical Industries' Synribo (omacetaxine mepesuccinate) for chronic myelogenous leukemia, or CML, a disease that the National Institutes of Health expects will be diagnosed in more than 5,400 people this year. The drug is intended for patients whose disease has progressed after treatment with at least two drugs of a class used to treat the disease.

October 25, 2012
FDA approves Par leukemia drug

The Food and Drug Administration has approved a generic drug for leukemia made by a subsidiary of Par Pharmaceutical Cos.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a generic drug for leukemia made by a subsidiary of Par Pharmaceutical Cos.

Par said Thursday that the FDA had approved Anchen Pharmaceuticals' tretinoin capsules in the 10-mg strength.

The drug is a generic version of Roche's Vesanoid, various versions of which have annual sales of about $29 million, according to IMS Health.

October 22, 2012
Astellas bladder drug made available in U.S.

The U.S. subsidiary of Japanese drug maker Astellas Pharma has made a drug for overactive bladder available in U.S. pharmacies, the company said.

NORTHBROOK, Ill. — The U.S. subsidiary of Japanese drug maker Astellas Pharma has made a drug for overactive bladder available in U.S. pharmacies, the company said.

Astellas Pharma US announced the availability of Myrbetriq (mirabegron) extended-release tablets. The drug is used to treat OAB with symptoms of urge urinary incontinence, urgency and urinary frequency. The Food and Drug Administration approved the drug on June 28, 2012.

October 22, 2012
FDA approves Eisai's Fycompa for epilepsy

The Food and Drug Administration has approved a new drug for epilepsy, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for epilepsy, the agency said Monday.

The FDA announced the approval of Eisai's Fycompa (perampanel) tablets to treat partial-onset seizures in patients ages 12 years and older. Partial seizures are the most common type seen in people with epilepsy, according to the FDA.

October 22, 2012
Pharmavite launches Voots supplements for children

Pharmavite has introduced Voots Veggie-Fruit Tarts, a fruit- and vegetable- based supplement for children ages 4 years and older that provides the antioxidants found in three servings of fruits and vegetables in two chewable berry-flavored tarts.

NORTHRIDGE, Calif. – Pharmavite has introduced Voots Veggie-Fruit Tarts, a fruit- and vegetable- based supplement for children ages 4 years and older that provides the antioxidants found in three servings of fruits and vegetables in two chewable berry-flavored tarts.

Voots are made with a blend of 11 fruits and vegetables and are blended with vitamin C and other ingredients before being pressed into tablets. Voots do not contain any artificial flavors, colors or preservatives. The tablets come in convenient single-serve packets so that kids can enjoy them on-the-go.

October 19, 2012
FDA gives tentative approval to Cipla combo pill for HIV

The Food and Drug Administration has given tentative approval to a new drug for HIV made by an Indian company.

SILVER SPRING, Md. — The Food and Drug Administration has given tentative approval to a new drug for HIV made by an Indian company.

FDA records show that the agency gave tentative approval tablets and oral suspension that combine lamivudine, nevirapine and zidovudine in the 30-mg/50-mg/60-mg strength.

October 19, 2012
Pharmacy OneSource releases new version of Simplifi 797 pharmacy compounding software

A division of Wolters Kluwer Health has released a new version of a Web-based quality-assurance software for pharmacy compounding.

BELLEVUE, Wash. — A division of Wolters Kluwer Health has released a new version of a Web-based quality-assurance software for pharmacy compounding.

Pharmacy OneSource announced the release of a new version of Simplifi 797, used for ensuring compliance with USP chapter 797 regulations, which call for proper training of staff who prepare sterile compounded products.

October 19, 2012
Star Nutrition launches arm, calf sleeves designed to increase circulation

Star Nutrition on Wednesday added the TEC-3 arm and calf sleeves to its Incrediwear line.

CHICO, Calif. — Star Nutrition on Wednesday added the TEC-3 arm and calf sleeves to its Incrediwear line. Engineered from an Italian 3-D weaving machine and utilizing Carbonized Charcoal Anion Technology, the 360-thread count TEC-3 is designed to increase circulation to the arms and calves, while decreasing fatigue, swelling and recovery time.

October 18, 2012
FDA approves first drug for eye condition

The Food and Drug Administration has approved what it called the first drug to treat an eye condition that can interfere with the part of the retina responsible for reading vision.

SILVER SPRING, Md. — The Food and Drug Administration has approved what it called the first drug to treat an eye condition that can interfere with the part of the retina responsible for reading vision.

The agency announced the approval of Jetrea (ocriplasmin), made by Iselin, N.J.-based ThromboGenics. The drug is used to treat symptomatic vitreomacular adhesion.

October 18, 2012
FDA approves generic Lupin contraceptive

The Food and Drug Administration has approved a generic contraceptive made by Indian drug maker Lupin, the company said Thursday.

MUMBAI, India — The Food and Drug Administration has approved a generic contraceptive made by Indian drug maker Lupin, the company said Thursday.

Lupin announced the approval of Kurvelo (levonorgestrel and ethinyl estradiol) tablets in the 0.15 mg/0.03 mg strength.

The drug is a generic version of Teva's branded Nordette. Nordette had sales of about $59 million during the 12-month period ended in June, according to IMS Health.

October 17, 2012
Busy Breathers gains online distribution for portable oxygen backpacks

Busy Breathers on Tuesday announced the availability of its portable oxygen backpacks on e-commerce sites Drugstore.com and Walgreens.com and in 75 Walgreens locations throughout Colorado.

DENVER — Busy Breathers on Tuesday announced the availability of its portable oxygen backpacks on e-commerce sites Drugstore.com and Walgreens.com and in 75 Walgreens locations throughout Colorado.  

October 12, 2012
FDA approves Celgene lung-cancer drug

The Food and Drug Administration has approved an injected drug for lung cancer made by Celgene, the company said Friday.

SUMMIT, N.J. — The Food and Drug Administration has approved an injected drug for lung cancer made by Celgene, the company said Friday.

Celgene announced the approval of Abraxane (paclitaxel) protein-bound particles for injectable suspension, for the first-line treatment of non-small cell lung cancer that has advanced locally or spread to other parts of the body, in combination with carboplatin, for patients who are not candidates for curative surgery or radiation therapy.

October 12, 2012
FDA approves new use for Genentech arthritis drug

The Food and Drug Administration has approved a new use for a drug made by Roche division Genentech.

SOUTH SAN FRANCISCO, Calif. — The Food and Drug Administration has approved a new use for a drug made by Roche division Genentech.

The drug maker said Friday that the FDA had approved Actemra (tocilizumab) for adults with moderately to severely active rheumatoid arthritis who have not responded adequately to one or more disease-modifying antirheumatic drugs. The drug was already approved for systemic juvenile idiopathic arthritis.

October 12, 2012
FDA approves Sandoz dermatology drug

The Food and Drug Administration has approved a drug made by Sandoz for treating symptoms of various skin diseases.

PRINCETON, N.J. — The Food and Drug Administration has approved a drug made by Sandoz for treating symptoms of various skin diseases.

Sandoz, the generics arm of Swiss drug maker Novartis, announced the approval of desoximetasone ointment in the 0.25% strength. The drug is a generic version of Taro Pharmaceutical Industries' Topicort and, according to Sandoz, is the first Fougera dermatology product Sandoz has launched since its $1.5 billion acquisition of the company in May 2012.

October 12, 2012
Kirby Lester to introduce updated tablet counter

Pharmacy automation manufacturer Kirby Lester has launched a version of one of its tablet counters with streamlined verification software.

LAKE FOREST, Ill. — Pharmacy automation manufacturer Kirby Lester has launched a version of one of its tablet counters with streamlined verification software.

The company announced the launch of KL1Plus, which it said combines the KL1 tablet counter with the updated software. The device will be introduced at the National Community Pharmacists Association and Department of Defense Joint Forces Pharmacy Services annual convention in San Diego this month.

October 10, 2012
AccuDial launches line of Go-Green children's cough and cold products

AccuDial Pharmaceutical recently launched four products as part of its Go-Green pediatric liquid cough-cold lineup that features dosing information on a rotating label, a larger 6-point font and a dosing cup that's shrink-wrapped to the top of the container.

PALM BEACH GARDENS, Fla. — AccuDial Pharmaceutical recently launched four products as part of its Go-Green pediatric liquid cough-cold lineup that features dosing information on a rotating label, a larger 6-point font and a dosing cup that's shrink-wrapped to the top of the container.

October 10, 2012
Nipro Diagnostics launches the TruePlus brand, featuring more than 30 diabetes-related products

Nipro Diagnostics on Wednesday announced the introduction of a new portfolio of more than 30 ancillary products targeted to meet the needs of individuals with diabetes.

FORT LAUDERDALE, Fla. — Nipro Diagnostics on Wednesday announced the introduction of a new portfolio of more than 30 ancillary products targeted to meet the needs of individuals with diabetes. The TruePlus products are designed to offer innovative, affordable solutions for diabetes patients to lead healthier lives.

October 10, 2012
Perrigo launches store-brand nicotine mini lozenges

Perrigo on Wednesday announced that it has received approval from the Food and Drug Administration for its abbreviated new drug applications to market over-the-counter nicotine polacrilex mini lozenge USP in both 2-mg and 4-mg strengths.

ALLEGAN, Mich. — Perrigo on Wednesday announced that it has received approval from the Food and Drug Administration for its abbreviated new drug applications to market over-the-counter nicotine polacrilex mini lozenge USP in both 2-mg and 4-mg strengths. 

The mint-flavored mini lozenge is comparable with GlaxoSmithKline's Nicorette Mini Lozenge and is indicated to reduce withdrawal symptoms, including nicotine craving, associated with quitting smoking.

October 9, 2012
Mentholatum gearing up for holiday gift-giving with two new holiday flavors chosen by FB fans

Mentholatum on Tuesday launched its new Softlips Jack Frosting lip balm, Softlips peppermint stick lip balm and Softlips holiday gift tag packs that will be available in November in time for the holiday shopping season.

ORCHARD PARK, N.Y. — Mentholatum on Tuesday launched its new Softlips Jack Frosting lip balm, Softlips peppermint stick lip balm and Softlips holiday gift tag packs that will be available in November in time for the holiday shopping season.

October 5, 2012
AccuDial introduces five APAP products featuring readily comprehensive weight-based dosing instructions

AccuDial Pharmaceutical earlier this year introduced five SKUs across its Children’s AccuDial Acetaminophen Oral Suspension, featuring one of the only weight-based dosing acetaminophen products with an interactive, rotating label.

PALM BEACH GARDENS, Fla. — AccuDial Pharmaceutical earlier this year introduced five SKUs across its Children’s AccuDial Acetaminophen Oral Suspension, featuring one of the only weight-based dosing acetaminophen products with an interactive, rotating label. The single-ingredient products, indicated to help reduce fever in children, are timely for the coming cough-cold season. Children's AccuDial Acetaminophen Oral Suspension will retail for a suggested $4.99 and is available in five flavors: grape, dye-free cherry, cherry, bubble gum and strawberry.