New pharmacy products, new indications for existing products.
RX
NEW INDICATIONS
NOW AVAILABLE
Philadelphia-based GlaxoSmithKline, (888) 825-5249, reports that the once-a-day formulation of its cardiovascular drug Coreg (carvedilol phosphate) is now available nationwide. Coreg CR extended-release capsules are FDA-approved for three indications: hypertension, post-myocardial infarction left ventricular dysfunction, and mild to severe heart failure. The beta-blocker is bioequivalent to the previously approved, twice-daily Coreg formulation.
Par Pharmaceutical, Woodcliff Lake, N.J., (845) 425-7100, under an agreement with GlaxoSmithKline, is now distributing ranitidine hydrochloride syrup, a generic version of GSK's Zantac Syrup. The product is indicated for the treatment of ulcers and other chronic gastrointestinal conditions.
Lialda (mesalamine) with MMX Technology, is now available from Shire USA Inc., Wayne, Pa., (800) 828-2088. It is indicated for the induction of remission of active mild to moderate ulcerative colitis. According to the company, it is the only FDA-approved once-daily formulation of mesalamine. Lialda is available in strengths of 2.4 gm and 4.8 gm, allowing patients to take as few as two tablets once a day. MMX Technology, a trademark of Cosmo Technologies, Ireland, delays the release of the medication to the colon.
Sanofi-Aventis, Bridgewater, N.J., (908) 243-6000, has FDA approval for Allegra (fexofenadine hydrochloride) Oral Suspension. It offers treatment for symptoms associated with seasonal allergies in children aged two to 11 years. It can also be used to treat chronic idiopathic urticaria in children six months to 11 years of age. The suspension is available in a concentration of 30 mg/5 ml.
ETC.
EPS Inc., Ivyland, Pa., (800) 523-8966, has expanded its line of storage and transport items. New are Unit Dose and Medication Exchange Bins to handle unit-dose medication and IV bags; Bulk Supply Tubs for large and unwieldy items; Durable Stock Bins for carrying small products; Autoclavable Instrument Trays for items requiring special handling; and Mobile Utility Workstation Carts to move work areas and supplies simultaneously ... The company also has new EPS Sterile Labels for operating and procedure rooms. Available for most agents used at these facilities-and in one-half-inch and one-inch measurements-they can be used on syringes, bowls, basins, and most other containers. They are provided in sterile packages.
FDA Expands Tenofovir Alafenamide Indication to Treat HBV in Patients as Young as 6
March 28th 2024Tenofovir alafenamide was originally approved by the FDA in 2016 to treat adults with chronic HBV infection with compensated liver disease and in 2022 to treat pediatric patients aged 12 years and older.
FDA Approves Aprocitentan For Treatment of Uncontrolled High Blood Pressure
March 20th 2024Aprocitentan (TRYVIO) from pharmaceutical company Idorsia demonstrated statistically significant and clinically meaningful reductions in blood pressure in combination with other antihypertensive therapies.