Content about New Drugs & OTCs

August 12, 2013

Moberg Pharma AB announced its U.S. launch of Kerasal NeuroCream, an over-the-counter pain relieving foot cream.

STOCKHOLM, Sweden — Moberg Pharma AB today announced its U.S. launch of Kerasal NeuroCream, an over-the-counter pain relieving foot cream. This new product will be sold in over 3,800 Walmart stores and in CVS, Walgreens, and Rite Aid drug stores starting late August.

August 12, 2013

Perrigo Co. announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug applications for fluocinolone acetonide scalp oil, 0.01%, the generic equivalent to Derma-Smoothe/FS Scalp Oil, and fluocinolone acetonide topical oil, 0.01%, the generic equivalent to Derma-Smoothe/FS Body Oil.

ALLEGAN, Mich. — Perrigo Co. today announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug applications for fluocinolone acetonide scalp oil, 0.01%, the generic equivalent to Derma-Smoothe/FS Scalp Oil, and fluocinolone acetonide topical oil, 0.01%, the generic equivalent to Derma-Smoothe/FS Body Oil. Perrigo expects to begin shipments of both products next month.

August 12, 2013

Teva Pharmaceutical and Perrigo Co. announced the launch of the generic equivalent to Temodar (temozolomide). Teva will manufacture, market and distribute the product in the United States, and both companies will equally share in the cost and profitability of the product in the country.

JERUSALEM and ALLEGAN, Mich. — Teva Pharmaceutical Industries Ltd., and Perrigo Co. today announced the launch of the generic equivalent to Temodar (temozolomide). Teva will manufacture, market and distribute the product in the United States, and both companies will equally share in the cost and profitability of the product in the country. Teva was first to file, making the product eligible for 180 days of marketing exclusivity.

August 8, 2013

Eisai announced that the Food and Drug Administration has granted orphan drug designation to its investigational compound (E7777) for cutaneous T-cell lymphoma.

WOODCLIFF LAKE, N.J. — Eisai Inc., announced today that the U.S. Food and Drug Administration has granted orphan drug designation to its investigational compound (E7777) for cutaneous T-cell lymphoma. E7777 is designed to have an improved purity profile and manufacturing process. It is currently in a pivotal trial intended to support its submission for approval.

August 8, 2013

Keryx Biopharmaceuticals announced the submission of a new drug application to the Food and Drug Administration seeking approval for the marketing and sale of Zerenex (ferric citrate coordination complex), the company's drug candidate for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with chronic kidney disease on dialysis.

NEW YORK — Keryx Biopharmaceuticals, Inc., today announced the submission of a new drug application to the U.S. Food and Drug Administration seeking approval for the marketing and sale of Zerenex (ferric citrate coordination complex), the company's drug candidate for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with chronic kidney disease on dialysis.

August 6, 2013

Actavis has acquired global rights to a drug made by a Spanish company for fungal infections of the vagina, the companies said Tuesday.

PARSIPPANY, N.J. — Actavis has acquired global rights to a drug made by a Spanish company for fungal infections of the vagina, the companies said Tuesday.

Actavis and Palau Pharma announced that Actavis Specialty Brands had acquired right's to albaconazole, an orally administered antifungal for vulvo-vaginal candidiasis, onychomycosis and others. The drug, which Palau discovered, is currently in phase-2 clinical trials, and Actavis foresees a potential U.S. commercial launch of the drug in 2017.

August 5, 2013

Amneal Pharmaceuticals has introduced five new generic drugs, the company said.

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has introduced five new generic drugs, the company said.

The drugs launched are:

Potassium chloride extended-release capsules in the 750-mg strength and in bottle count sizes of 100, 500 and 1,000. The drug is a generic version of Nesher Pharmaceuticals' Micro-K10 ExtenCaps and used to treat potassium deficiency.

Sildenafil tablets in the 20-mg strength and in 90-count bottles. The drug is a generic version of Pfizer's Revatio, used to treat pulmonary arterial hypertension.

August 5, 2013

The Food and Drug Administration has approved for shipment the latest version of a GlaxoSmithKline flu vaccine, the drug maker said Monday.

PHILADELPHIA — The Food and Drug Administration has approved for shipment the latest version of a GlaxoSmithKline flu vaccine, the drug maker said Monday.

The FDA approved the Fluarix Quadrivalent (influenza virus vaccine) for the 2013-2014 season for shipment to Centers for Disease Control and Prevention distribution centers and healthcare providers. GSK said this would be the first season in which vaccines protecting against more than three strains will be available.

August 5, 2013

A new treatment for bacterial infections of the vagina is now available, the drug's manufacturer said.

ST. LOUIS — A new treatment for bacterial infections of the vagina is now available, the drug's manufacturer said Monday.

K-V Pharmaceutical Co. subsidiary Ther-Rx Corp. announced the availability of Clindesse (clindamycin phosphate), saying wholesalers have ordered and received it and are distributing it to retail pharmacies. The drug is used to treat bacterial vaginosis in women who are not pregnant. BV results from an overgrowth of several bacterial species and is the most common vaginal infection in women of childbearing age.

August 2, 2013

The Food and Drug Administration has approved a vaccine against meningococcal disease for use among patients of a broader age range than before.

CAMBRIDGE, Mass. — The Food and Drug Administration has approved a vaccine against meningococcal disease for use among patients of a broader age range than before.

July 31, 2013

The Food and Drug Administration has approved a Perrigo generic drug for treating dermatitis, the company said Wednesday.

ALLEGAN, Mich. — The Food and Drug Administration has approved a Perrigo generic drug for treating dermatitis, the company said Wednesday.

Perrigo announced the FDA approval of fluticasone propionate lotion in the 0.05% strength. The drug is a generic version of Fougera Pharmaceuticals division PharmaDerm's Cutivate and is used to treat inflammatory and pruritic manifestations of atopic dermatitis in patients ages 1 year and older.

The drug has annual sales of about $19 million, according to Symphony Health Solutions.

 

July 31, 2013

The Food and Drug Administration has given Lupin Pharmaceuticals tentative approval to two of its products, the company said Wednesday.

BALTIMORE — The Food and Drug Administration has given Lupin Pharmaceuticals tentative approval to two of its products, the company said Wednesday.

Lupin announced the tentative approvals for armodafinil tablets in the 50-mg, 100-mg, 150-mg, 200-mg and 250-mg strengths and doxycycline capsules in the 40-mg strength. Tentative approval means that the drugs meet the FDA's conditions for approval, but can't be marketed yet due to patent or market exclusivity protection that has yet to expire.

July 31, 2013

Nearly 450 drugs are under development for treating neurological disorders, according to a report by a drug industry trade group.

WASHINGTON — Nearly 450 drugs are under development for treating neurological disorders, according to a report by a drug industry trade group.

The Pharmaceutical Research and Manufacturers of America said in a report released Wednesday that drug makers had 444 drugs in clinical development or awaiting Food and Drug Administration approval for a range of diseases, ranging from mild to serious.

July 29, 2013

Actavis hopes to become the first to market a generic drug for treating chronic pain, the company said.

PARSIPPANY, N.J. — Actavis hopes to become the first to market a generic drug for treating chronic pain, the company said Monday.

Actavis said it had filed with the Food and Drug Administration for approval of tapentadol extended-release tablets in the 50-mg, 100-mg, 150-mg and 200-mg strengths. The drug is a generic version of Johnson & Johnson subsidiary Janssen Pharmaceuticals' Nucynta ER. The drug is used as a continuous, around-the-clock analgesic over a long period of time.

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 29, 2013

Dr. Reddy's Labs has launched a generic drug used to treat Alzheimer's disease, the company said.

HYDERABAD, India — Dr. Reddy's Labs has launched a generic drug used to treat Alzheimer's disease, the company said.

The Indian drug maker announced the launch of donepezil hydrochloride tablets in the 23-mg strength, a generic version of Eisai and Pfizer's Aricept. The drug is being launched in 30- and 90-count bottles.

Aricept in the 23-mg strength had sales of about $92.6 million during the 12-month period that ended in May, according to IMS Health.

 

July 29, 2013

Reckitt Benckiser will be launching a product for nighttime cold and flu relief in both liquid and tablet form, the company's CEO told investors Monday morning.

SLOUGH, England — Reckitt Benckiser will be launching a product for nighttime cold and flu relief in both liquid and tablet form, the company's CEO told investors Monday morning. 

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 24, 2013

Canadian regulators have approved two drugs made by GlaxoSmithKline for treating skin cancer.

MISSISSAUGA, Ontario — Canadian regulators have approved two drugs made by GlaxoSmithKline for treating skin cancer, GSK said Wednesday.

The drug maker announced Health Canada's approval of Tafinlar (dabrafenib mesylate) and Mekinist (trametinib) in patients with melanoma that can't be removed by surgery or has spread to other parts of the body.

July 24, 2013

Miraculins announced the launch of its PreVu Non-Invasive Skin Cholesterol Point of Care Test exclusively through some 20 H-E-B locations over fourth quarter 2013.

WINNIPEG, Manitoba — Miraculins on Wednesday announced the launch of its PreVu Non-Invasive Skin Cholesterol Point of Care Test exclusively through some 20 H-E-B locations over fourth quarter 2013. 

July 24, 2013

Mylan has settled with the makers of a drug used to treat cancer in a patent-infringement lawsuit, the generic drug maker said.

PITTSBURGH — Mylan has settled with the makers of a drug used to treat cancer in a patent-infringement lawsuit, the generic drug maker said Wednesday.

Mylan said it had entered an agreement with Pfizer, Genentech and OSI that would allow their suit against Mylan over the drug Tarceva (erlotinib) to be dismissed. All other terms and conditions of the settlement are confidential, and the agreement is subject to Department of Justice and Federal Trade Commission review, Mylan said.

July 23, 2013

The Food and Drug Administration has approved a generic diabetes drug made by Lupin, the company said.

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

Lupin, based in India, received approval for metformin hydrochloride extended-release tablets in the 500-mg and 1,000-mg strengths. The drug is a generic version of Santarus' Glumetza.

Glumetza had sales of about $144 million during the 12-month period that ended in March, according to IMS Health. The drug is an extended-release formulation of metformin hydrochloride, a widely prescribed drug used for treating Type 2 diabetes.

 

July 22, 2013

The Food and Drug Administration has approved a drug made by Japanese drug maker Astellas for preventing the body from rejecting transplanted organs, the company said.

NORTHBROOK, Ill. — The Food and Drug Administration has approved a drug made by Japanese drug maker Astellas for preventing the body from rejecting transplanted organs, the company said.

Astellas announced through a U.S. subsidiary that the FDA had approved Astagraf XLTM (tacrolimus) extended-release capsules for preventing rejection of transplanted kidneys, for use with Genentech's CellCept (mycophenolate mofetil) and corticosteroids, with or without Simulect (basiliximab), a biotech drug made by Swiss drug maker Novartis.

July 22, 2013

Fuse Science's new products ElectroFuse and PowerFuse were named "Best New Products" by retailers attending ECRM's Diet, Vitamin and Sports Nutrition conference.

SCOTTSDALE, Ariz. — Fuse Science's new products ElectroFuse and PowerFuse were named "Best New Products" by retailers attending ECRM's Diet, Vitamin and Sports Nutrition conference here earlier this month. 

July 22, 2013

An announcement Monday by generic drug maker Sandoz gives a glimpse of what could happen in the United States when biosimilars start to become available.

HOLZKIRCHEN, Germany — An announcement Monday by generic drug maker Sandoz gives a glimpse of what could happen in the United States when biosimilars start to become available.