Content about New Drugs & OTCs

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.

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.

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.

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.

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.

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.

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.

ANAHEIM, Calif. — Aculief on Friday will showcase its recently released Aculief "wearable acupressure" product at the Natural Products Expo West here. 

Aculief applies pressure to the LI4 acupressure point, located between the thumb and forefinger. The LI4 has been used in traditional Chinese medicine to relieve tension and to promote your body’s natural flow of energy. 

NORTH ANDOVER, Mass. — Nelsons on Thursday launched Rescue Pearls, dissolvable gel capsules that provide relief from daily stress. Each pearl releases one dose of Rescue Remedy. 

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has started shipping a drug used to treat opioid dependence, the company said Tuesday.

The generic drug maker announced the shipment of buprenorphine hydrochloride and naloxone hydrochloride dihydrate sublingual tablets in the 2-mg/0.5-mg and 8-mg/2-mg strengths. The Food and Drug Administration approved the drug in February.

The drug includes a risk evaluation and mitigation strategy, or REMS, a program required by the FDA to ensure that its benefits outweigh its risks.

PRINCETON, N.J. — Ranbaxy Labs will market a drug for depression under an agreement with another company, the drug maker said Tuesday.

Ranbaxy said it had entered an in-licensing agreement with Alembic Pharmaceuticals to market desvenlafaxine base extended-release tablets. Alembic is the sponsor of a new drug application filed with the Food and Drug Administration for the drug, which is bioequivalent to Pfizer's Pristiq. Pristiq had sales of $590 million during the 12-month period that ended in January.