New product newswire
The FDA has given marketing approval to Torontobased Biovail Corp., (905) 286-3000, for the company's once-daily Tramadol ER, an extended-release, oncedaily formulation of tramadol hydrochloride, in strengths of 100, 200, and 300 mg. The pain-killing medication is indicated for the treatment of moderate to moderately severe chronic pain in adults who require round-the-clock pain treatment.
RX
NEW DRUGS
The FDA has given marketing approval to Torontobased Biovail Corp., (905) 286-3000, for the company's once-daily Tramadol ER, an extended-release, oncedaily formulation of tramadol hydrochloride, in strengths of 100, 200, and 300 mg. The pain-killing medication is indicated for the treatment of moderate to moderately severe chronic pain in adults who require round-the-clock pain treatment.
Acombination vaccine from Merck & Co., Whitehouse Station, N.J., (908) 423-1000, protects against four childhood diseases in a single inoculation. Proquad (measles, mumps, rubella, and varicella [Oka/Merck] virus vaccine live) protects against those diseases in children 12 months to 12 years of age and can be used if a second dose against measles, mumps, and rubella is needed.
FULL APPROVAL GRANTED
Arimidex (anastrozole), previously granted conditional FDA approval, has now gained full approval for adjuvant treatment of hormone receptor-positive early breast cancer in postmenopausal women. According to the company, the aromatase inhibitor shows five years of efficacy and safety data in this primary adjuvant setting. Arimidex is a product of AstraZeneca, Wilmington, Del., (800) 842-9920.
NEW INDICATIONS
NovoLog (insulin aspart [rDNA origin] injection) has been approved for the treatment of diabetes in children. The rapid-acting insulin analog can be administered immediately before a meal to control hypoglycemia. It is available in the prefilled NovoLog FlexPen insulin delivery system and is also approved for use in insulin pumps. The manufacturer is Novo Nordisk, Princeton, N.J., (800) 727-6500. NovoLog was approved earlier for treating diabetes in adult patients.
Remicade (infliximab), a product of Centocor Inc., Horsham, Pa., (610) 651-6000, has become the first biologic approved by the FDA for the treatment of ulcerative colitis. It is used to reduce signs and symptoms, achieve clinical remission and mucosal healing, and eliminate corticosteroid use in patients with moderately to severely active UC who have been recalcitrant to conventional therapy. Remicade was approved earlier for rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, and psoriatic arthritis.
NEW FORMULATIONS
Axcan Pharma, Quebec, (450) 467-5138, has launched the Canasa (mesalamine) suppository in 1000-mg strength as a once-daily treatment for ulcerative proctitis. According to the company, the 1000-mg suppository is as effective as the twice-daily 500-mg version but should improve compliance.
The Sanofi-Aventis Group, Bridgewater, N.J., (908) 243-6000, has FDA approval for Ambien CR (zolpidem tartrate extended-release tablets) CIV. This is a nonnarcotic, non-benzodiazepine formulation that in a twostage release provides sleep maintenance in addition to sleep induction. The drug will be available in two recommended dosage strengths: 12.5 mg for adults and 6.25 mg for elderly patients.
A sugar-free formulation of Actiq (oral transmucosal fentanyl citrate) CII, bioequivalent to the currently available product, was approved for Cephalon Inc., Frazer, Pa., (610) 344-0200. The pain-relieving medicated lozenge is an opioid analgesic used for breakthrough cancer pain.
FDA Approves Second Formulation of Humira Biosimilar Cyltezo
May 1st 2024According to Michael Osso, president and chief executive officer of the Crohn’s & Colitis Foundation, “the flexibility of having multiple biosimilar formulations to choose from is important to support broader patient access to biologic medicine.”
