Content about New Drugs & OTCs

March 29, 2013

The Food and Drug Administration has approved a new drug made by Johnson & Johnson for treating Type 2 diabetes, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by Johnson & Johnson for treating Type 2 diabetes, the agency said.

The FDA announced the approval of J&J subsidiary Janssen Pharmaceuticals' Invokana (canagliflozin) tablets, designed for use with diet and exercise to improve blood-sugar control in adults with the disease.

March 29, 2013

Vitamin Squeeze announced the release of a full line of powdered water enhancers available in supermarkets nationwide.

PHOENIX — Vitamin Squeeze announced today the release of a full line of powdered water enhancers available in supermarkets nationwide.

Vitamin Squeeze Powder Water Enhancers come in eight flavors and three varieties:

  • Multi-Vitamin (Fruit Punch, Acai Grape Pomegranate, Strawberry Watermelon and Lemonade);

  • Energy (Black Cherry, Blood Orange and Blueberry Pomegranate Acai); and

March 28, 2013

Hamacher Resource Group has been invited to present a continuing education session, “Bottom Line Performance: Opportunities and Actions,” at the Mutual Drug Spring CE Forum on April 7 in Raleigh, N. C., the company announced.

WAUKESHA, Wis. — Hamacher Resource Group has been invited to present a continuing education session, “Bottom Line Performance: Opportunities and Actions,” at the Mutual Drug Spring CE Forum on April 7 in Raleigh, N.C., the company announced today.

March 28, 2013

Itonis Pharmaceuticals unveiled the company's initial marketing plans for an over-the-counter homeopathic product that helps relieve nausea.

AGUNA HILLS, Calif. — Itonis Pharmaceuticals on Thursday unveiled the company's initial marketing plans for an over-the-counter homeopathic product that helps relieve nausea.

March 27, 2013

The Food and Drug Administration has approved a drug administered through a new line of injection devices made by BD, the company said Wednesday.

FRANKLIN LAKES, N.J. — The Food and Drug Administration has approved a drug administered through a new line of injection devices made by BD, the company said Wednesday.

BD announced the approval of diphenhydramine hydrochloride injection, an antihistamine, packaged in its recently launched Simplist pre-filled injectables, which are made by subsidiary BD Rx and designed to improve patient care and safety by decreasing the number of steps in the traditional vial and syringe injection sequence and thus reduce the potential risk of medication errors.

March 27, 2013

The Food and Drug Administration has approved a new treatment for multiple sclerosis made by Biogen Idec, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for multiple sclerosis made by Biogen Idec, the agency said Wednesday.

The FDA announced the approval of Tecfidera (dimethyl fumarate) capsules for adults with relapsing forms of MS.

March 27, 2013

Pharmacies using McKesson EnterpriseRx pharmacy-management system can send patients information about health clinics, drug recalls, coupons and real-time surveys through their mobile phones using an integrated mobile communication system.

NEW YORK — Pharmacies using McKesson EnterpriseRx pharmacy-management system can send patients information about health clinics, drug recalls, coupons and real-time surveys through their mobile phones using an integrated mobile communication system.

Mscripts said Wednesday that its pre-built integration with EnterpriseRx would allow pharmacists to implement quickly and cost-effectively, communicating with patients through two-way, interactive SMS text messaging and mobile applications on iPhone, Android and Windows Phone devices.

March 26, 2013

The Food and Drug Administration has approved a drug for opioid dependence made by Actavis, the company said.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a drug for opioid dependence made by Actavis, the company said.

Actavis announced the approval of buprenorphine hydrochloride and naloxone hydrochloride dehydrate sub-lingual tablets in the 2 mg/0.5 mg and 8 mg/2 mg strengths.

The drug is a generic version of Reckitt Benckiser's Suboxone, which had sales of about $625 million in 2012, according to IMS Health.

 

March 26, 2013

GNC extended its Preventive Nutrition brand to help supplement a number of conditions, including eye health, liver health and digestive health.

PITTSBURGH — GNC on Tuesday extended its Preventive Nutrition brand to help supplement a number of conditions, including eye health, liver health and digestive health.  

March 25, 2013

Generic drug maker Actavis has reached a deal with AstraZeneca that will allow it to launch a version of a drug used to treat cholesterol in three years, Actavis said Monday.

PARSIPPANY, N.J. — Generic drug maker Actavis has reached a deal with AstraZeneca that will allow it to launch a version of a drug used to treat cholesterol in three years, Actavis said Monday.

Under a deal to settle a patent-infringement lawsuit, Actavis will be allowed to launch its generic version of Crestor (rosuvastatin calcium) tablets in the 5-mg, 10-mg, 20-mg and 40-mg strengths 67 days before July 8, 2016, when the drug's market exclusivity for use in children expires, at a fee of 39% of net sales to AstraZeneca.

March 25, 2013

More than 400 drugs are under development for the 10 most common chronic health conditions affecting elderly people, according to a new report by a drug industry trade group.

WASHINGTON — More than 400 drugs are under development for the 10 most common chronic health conditions affecting elderly people, according to a new report by a drug industry trade group.

March 25, 2013

The Food and Drug Administration has approved a treatment for managing a type of bacterial infection in patients with cystic fibrosis.

EAST HANOVER, N.J. — The Food and Drug Administration has approved a treatment for managing a type of bacterial infection in patients with cystic fibrosis.

Swiss drug maker Novartis announced the approval of Tobi Podhaler (tobramycin inhalation powder) for managing cystic fibrosis patients with Pseudomonas aeruginosa, or Pa bacteria, in the lungs.

March 25, 2013

Boehringer Ingelheim and Eli Lilly are seeking regulatory approval for an experimental drug to treat Type 2 diabetes, the companies said.

RIDGEFIELD, Conn. — Boehringer Ingelheim and Eli Lilly are seeking regulatory approval for an experimental drug to treat Type 2 diabetes, the companies said Monday.

BI and Lilly announced the submission of a regulatory application to the Food and Drug Administration for empagliflozin. The drug belongs to a new drug class known as SGLT2 inhibitors, which work by removing excess glucose through the urine by blocking its reabsorption in the kidneys. The companies are testing the drug in a late-stage clinical trial for which they plan to enroll 14,500 patients.

March 25, 2013

SanMedica International introduced its SeroVital-HGH, a new oral human-growth hormone booster formulated with women in mind, at the Academy of Women's Health's Annual Congress.

WASHINGTON —  SanMedica International on Friday introduced its SeroVital-HGH, a new oral human-growth hormone booster formulated with women in mind, at the Academy of Women's Health's Annual Congress here. 

March 21, 2013

Alcon has launched a mobile website designed to facilitate dialogue between patients and pharmacists about eye and ear treatments, the company said.

NEW YORK — Alcon has launched a mobile website designed to facilitate dialogue between patients and pharmacists about eye and ear treatments, the company said Thursday.

Alcon announced the launch of Drops101 Web Tools, which offers access to information about two of its products: Ciprodex Otic (ciprofloxacin and dexamethasone), for acute otitis externa and acute otitis media in children with tymponostomy tubes; and Moxeza ophthalmic solution (moxifloxacin hydrochloride) for bacterial conjunctivitis.

March 21, 2013

New Chapter voluntarily recalled a limited number of packages of its 90-count Probiotic Elderberry dietary supplement because it may contain an undeclared allergen - soy.

BRATTLEBORO, Vt. — New Chapter on Wednesday voluntarily recalled a limited number of packages of its 90-count Probiotic Elderberry dietary supplement because it may contain an undeclared allergen - soy. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume this product, the company stated.  

The one lot of affected New Chapter Probiotic Elderberry was distributed nationwide. It reached consumers through retail stores, mail order and direct delivery.

March 20, 2013

Hamacher Resource Group is offering pharmacists a new service that it said would allow them to get the top prescriptions dispensed in their two-digit ZIP code to ensure they are accurately and competitively pricing drugs.

WAUKESHA, Wis. — Hamacher Resource Group is offering pharmacists a new service that it said would allow them to get the top prescriptions dispensed in their two-digit ZIP code to ensure they are accurately and competitively pricing drugs.

HRG said the service, Rx Top Sellers, would provide data on the top 200, 500, 750 or 1,000 prescriptions and include cash median prices that are charged by food-drug retailers and independent pharmacies, as well as mass merchandise retailers.

March 20, 2013

The Food and Drug Administration has approved and launched two generic contraceptives made by Sandoz, the drug maker said.

PRINCETON, N.J. — The Food and Drug Administration has approved and launched two generic contraceptives made by Sandoz, the drug maker said.

Sandoz, the generics division of Swiss drug maker Novartis, announced the approval of Estarylla (norgestimate and ethinyl estradiol tablets) and Tri-Estarylla (norgestimate and ethinyl estradiol tablets), generic versions of Johnson & Johnson's Ortho Cyclen and Ortho Tri-Cyclen, respectively. Sandoz said the launches brought the total number of oral contraceptives it has launched since the beginning of 2011 to six.

March 18, 2013

Galena Biopharma has purchased rights to a treatment for breakthrough cancer pain from a Swedish drug maker, Galena said Monday.

LAKE OSWEGO, Ore. — Galena Biopharma has purchased rights to a treatment for breakthrough cancer pain from a Swedish drug maker, Galena said Monday.

Galena, which specializes in cancer-related drugs, said it acquired Abstral (fentanyl) sublingual tablets for sale and distribution in the United States from Orexo AB. Breakthrough cancer pain, or BTcP, affects between 40% to 80% of cancer patients, with reported episodes of four per day and a median duration of 30 minutes, according to Galena.

March 18, 2013

Perrigo announced that it has begun shipments of guaifenesin 600-mg extended-release tablets. It's the first product that is generically equivalent to Reckitt Benckiser's Mucinex 600-mg extended-release tablets.

ALLEGAN, Mich. — Perrigo on Monday announced that it has begun shipments of guaifenesin 600-mg extended-release tablets. It's the first product that is generically equivalent to Reckitt Benckiser's Mucinex 600-mg extended-release tablets. 

March 18, 2013

Robinson Pharma introduced its Unique IS-2 Probiotic Softgel in collaboration with B&D Nutritional Ingredients and Unique Biotech USA.

SANTA ANA, Calif. — Robinson Pharma last week introduced its Unique IS-2 Probiotic Softgel in collaboration with B&D Nutritional Ingredients and Unique Biotech USA. The new product is a shelf-stable, guaranteed-yield probiotic softgel that delivers the Unique IS-2 Bacillus coagulans strain, a trademarked bacterium which has demonstrated high resistance to extreme temperature and humidity.

March 15, 2013

Cardium Therapeutics announced its To Go Brands operating unit has expanded its VitaRocks kids' vitamins product line and that retail distribution has been expanded into select Target stores.

SAN DIEGO — Cardium Therapeutics earlier this week announced its To Go Brands operating unit has expanded its VitaRocks kids' vitamins product line and that retail distribution has been expanded into select Target stores.

The VitaRocks products are inspired by a popping pellet candy that is popular with kids and represents a next-generation, easy-use delivery platform for multivitamins and nutrients, dietary supplements, and potentially over-the-counter medicines for children as well as adults, Cardium Therapeutics suggested. 

March 14, 2013

Mylan has settled a patent-infringement lawsuit filed by Shionogi over its generic version of a drug for diabetes, Mylan said.

PITTSBURGH — Mylan has settled a patent-infringement lawsuit filed by Shionogi over its generic version of a drug for diabetes, Mylan said.

The generic drug maker said that under the agreement, it can launch a generic version of Shionogi's Fortamet (metformin hydrochloride) extended-release tablets in the 500-mg and 1,000-mg strengths on Aug. 1.

Metformin hydrochloride extended-release tablets in those two strengths had sales of about $125 million during the 12-month period that ended in September, according to IMS Health.

 

March 14, 2013

Wegmans will be offering the popular cholesterol-lowering drug atorvastatin free of charge through the end of the year, according to a report published by the Philadelphia Inquirer.

PHILADELPHIA — Wegmans will be offering the popular cholesterol-lowering drug atorvastatin free of charge through the end of the year, according to a report published by the Philadelphia Inquirer Wednesday. 

March 12, 2013

Actavis is challenging Novartis' patent on a patch used to treat Alzheimer's disease, Actavis said.

PARSIPPANY, N.J. — Actavis is challenging Novartis' patent on a patch used to treat Alzheimer's disease, Actavis said.

The generic drug maker said it had filed with the Food and Drug Administration an amendment to its regulatory application for rivastigmine transdermal system to include the 13.3 mg-per-24-hours dosage strength, a generic version of Novartis' Exelon. Novartis filed suit against Actavis on Thursday in the U.S. District Court for the District of Delaware seeking to prevent commercialization of the generic version.