New product newswire: October 10, 2006
According to the company, this is the first FDA-approved orally disintegrating tablet form of prednisolone. The drug is used primarily for acute exacerbations of asthma in children and is also indicated for the control of severe, persistent asthma and to reduce the inflammation associated with various medical conditions, including arthritis and cancer. The drug will be marketed by Atlanta-based Alliant Pharmaceuticals.
RX
NEW DRUGS
Biomarin Pharmaceutical, Novato, Calif., (415) 884-6700, is introducing Orapred ODT (prednisolone sodium phosphate orally disintegrating tablets). According to the company, this is the first FDA-approved orally disintegrating tablet form of prednisolone. The drug is used primarily for acute exacerbations of asthma in children and is also indicated for the control of severe, persistent asthma and to reduce the inflammation associated with various medical conditions, including arthritis and cancer. The drug will be marketed by Atlanta-based Alliant Pharmaceuticals, (770) 817-4500.
Centocor Inc., Horsham, Pa., (610) 651-6000, has FDA approval to expand the indication for Remicade (infliximab). This anti-TNF therapy can now be used to inhibit progression of structural damage and improve physical function in patients with psoriatic arthritis. Remicade was already approved for reducing the signs and symptoms of active arthritis.
NEW GENERICS
Pittsburgh-based Mylan Laboratories, (724) 514-1800, has received tentative approvals for two new generics. Fluoxetine capsules are indicated for the treatment of premenstrual dysphoric disorder. Approval provides an alternative to Eli Lilly's branded drug Sarafem.... A generic alternative is now available also for Wyeth Pharmaceuticals' Effexor Tablets. Venlafaxine HCl tablets, available as 25 mg (base), 37.5 mg (base), 50 mg (base), 75 mg (base), and 100 mg (base), are indicated for the treatment of major depressive disorder.
Perrigo Co., Allegan, Mich., (800) 719-9260, with its partner, InvaGen Pharmaceuticals, received tentative approval for terbinafine hydrochloride tablets, 250-mg (base). Approval will provide a generic alternative to Novartis' Lamisil for the treatment of onychomycosis of the toenail or fingernail.
Ranbaxy Pharmaceuticals, Princeton, N.J., (609) 720-9200, has received tentative approval to manufacture and market risperidone oral solution, 1 mg/mL. The product is indicated for the treatment of schizophrenia and will, upon final approval, provide a generic alternative to Janssen's Risperdal Oral Solution.
OTC
A new calcium-enriched antacid, antigas tablet is now available from Thomas Pharmaceuticals, Matawan, N.J., (888) 922-1959. Acid + All is spearmint-flavored and sugar-free and comes packaged in a 32-count pill box.
