per day; our higher--dosage product is designed to simplify drug therapy and enhance patient compliance by eliminating the larger number of doses patients would be required to ingest because the highest dosage strength
currently available is 500 mg.," explains Bruce Downey, chairman and chief executive officer.
The submission is based on a pharmacokinetic study demonstrating bioequivalence of OXAYDO to its reference drug, Roxicodone (oxycodone hydrochloride tablets USP) at the 15 mg dosage strength
The company this month announced the introduction of trifluridine ophthalmic solution in dosage strength
of 7.5 mL.
The authorized genetic is offered in a dosage strength
of 7.5 mL.
Pharmaceuticals company Amneal Biosciences disclosed on Tuesday the approval and availability of its Triamcinolone Acetonide Injectable Suspension, USP in 40 mg/ml dosage strength
directly and through wholesalers and distributors.
The quantity limitations are based on the particular drug being prescribed and the dosage strength
. The limitations are aligned with Centers for Disease Control recommendations for acute and chronic pain.
The product, which is a programmed death-1 (PD-1) inhibitor, was earlier approved as a two-week dosing schedule for dosage strength
of 240mg for the treatment of various cancers including melanoma, non-small cell lung cancer, and renal cell carcinoma.
It is expected that 30mg dosage strength
of this product will be launched immediately.
The 27-mg dosage strength
was made available in December 2012, when Mallinckrodt received approval from the FDA to manufacture and market the tablets in all three dosage strengths
USFDA has approved new dosage strength
(16mg / 4mg) of Cassipa (buprenorphine and naloxone) sublingual film.
Critical success factors for prototype formulation development vary by dosage strength
. For a high dose (> 250 mg), critical API characteristics include flowability, compressability, and availability of material.