Generic Cleocin Launched by Mylan

Mylan has launched clindamycin palmitate hydrochloride for oral solution USP, 75 mg/5mL, which is the generic version of Pharmacia and Upjohn’s Cleocin solution.

The FDA granted final approval for Mylan’s abbreviated new drug application for the solution, which can treat serious infections caused by susceptible anaerobic bacteria and susceptible strains of streptococci, pneumococci, and staphylococci when less toxic alternatives are inappropriate.

Clindamycin palmitate hydrochloride had US sales of nearly $31 million for the fiscal year ending on March 31, 2016, according to IMS Health.

Clostridium difficile-associated diarrhea (CDAD) has been reported in patients who use antibacterial agents, including Cleocin. CDAD can range in severity from mild diarrhea to fatal colitis.

The most common adverse effects associated with Cleocin are abdominal pain, skin rashes, nausea, and vomiting.