New Products

August 15, 2011

A survey of new Rx, new generic, and new OTC products

Key Points

New drugs

ProStrakan Group PLC has received FDA approval for Rectiv (nitroglycerin ointment 0.4%) for the treatment of moderate-to-severe pain associated with chronic anal fissures. Rectiv is the only prescription product approved by FDA to treat this condition. ( http://www.prostrakan-usa.com/)

Fera has launched Garamycin (gentamicin sulfate) Ophthalmic Solution for the treatment of ocular bacterial infections such as conjunctivitis, keratitis, and blepharitis. Garamycin has been available in ointment form. ( http://www.ferapharma.com/ 414-434-6604)

FDA has approved Pfizer and Acura's Oxecta (oxycodone HCl tablets), a Schedule C-II controlled substance, for management of acute and chronic moderate-to-severe pain. ( http://www.pfizer.com/ 800-776-3637)

FDA approved Janssen's Xarelto (rivaroxaban), once-daily oral anticoagulant tablets for the prevention of deep vein thrombosis, which may lead to pulmonary embolism in knee- or hip-replacement surgery patients.

Hawthorn and Cypress announced FDA approval of Zutripro (hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine HCl oral solution) and Rezira (hydrocodone bitartrate and pseudoephedrine oral solution), C-III controlled substances, for the relief of cough and nasal congestion associated with the common cold in adults who are 18 years or older. ( http://www.hawthornrx.com/ 888-455-5253)

New indication

FDA has approved an infant-specific dose of Abbott's Creon (pancrelipase delayed-release capsules) to treat exocrine pancreatic insufficiency due to cystic fibrosis. The new dosage strength will provide 3,000 lipase units, 9,500 protease units, and 15,000 amylase units. ( http://www.creon.com/ 800-633-9110)

New generics

FDA has approved the generic versions of levofloxacin (Levaquin, PriCara). Generic tablets, oral solutions, or injectable solutions have been approved for 12 manufacturers. Levofloxacin is indicated to treat susceptible bacterial infections and to reduce incidence or progression of disease following exposure to inhalational anthrax.

OTC

New in allergy and sinus care from TriCord Pharmaceuticals, LAVI Dead Sea Salt products are unique in their mineral composition and concentration. The first 2 products in this line are a premixed nasal wash and a nasal decongestant spray. (918-599-7379)