Aurobindo Pharma Limited has announced that it has received final approval from the U.S. Food and Drug Administration for entacapone tablets USP, 200 mg, the generic equivalent to Comtan Tablets 200 mg.
Pharmacy organizations have written a joint letter to the Food and Drug Administration asking officials to delay enforcement of a July 1 electronic product-tracing deadline for prescription drug dispensers.
The Food and Drug Administration is concerned that too great a deviance from a reference drug appearance could affect compliance.
Sandoz has launched Glatopa, the first U.S. generic of Teva’s Copaxone (glatiramer acetate injection, 20-mg/ml ), a once-daily treatment for multiple sclerosis.
Eisai announced Monday that the Food and Drug Administration had given Fycompa approval to be used as an adjunctive therapy in treating primary generalized tonic-clonic seizures.
Teva announced Monday that it had introduced its generic version of Focalin XR (dexmethylphenidate hydrochloride) extended-release capsules in a new 20-mg dosage strength.
Acura Pharmaceuticals and Bayer Healthcare are partnering to develop a product with pseudoephedrine that would be resistant to being used in methamphetamine.
Diplomat Pharmacy announced Friday that it had acquired the Pennsylvania-based Burman’s Specialty Pharmacy, which will expand Diplomat’s hepatitis C specialty services.
Ateb, Inc. will use the messaging service to facilitate communication between its 500,000 active patients and their prescribers.