APP receives FDA nod for its two generics
APP Pharmaceuticals Inc. has received FDA approva
l for two generic dugs. The regulatory agency has approved APP Pharma’s Abbreviated New Drug Application (ANDA) for Caffeine Citrate Oral Solution, 20 mg/ml, which is a generic version of Bedford Laboratories’ Cafcit Oral Solution used for the short-term treatment of apnea in premature infants. The FDA has also approved the ANDA for bleomycin sulfate for injections, the generic version of Bristol-Myers Squibb’s cancer treatment drug Blenoxane.
