Mylan N.V. announced the U.S. launch of Clindamycin Palmitate Hydrochloride for Oral Solution USP, 75 mg/5 mL, which is a generic version of Pharmacia and Upjohn's Cleocin® Solution. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the treatment of serious infections caused by susceptible anaerobic bacteria and susceptible strains of streptococci, pneumococci and staphylococci when less toxic alternatives are inappropriate.
Clindamycin Palmitate Hydrochloride for Oral Solution USP, 75 mg/5 mL, had U.S. sales of approximately $30.9 million for the 12 months ending March 31, 2016, according to IMS Health.
Currently, Mylan has 253 ANDAs pending FDA approval representing $108.2 billion in annual brand sales, according to IMS Health. Forty-three of these pending ANDAs are potential first-to-file opportunities, representing $37.2 billion in annual brand sales, for the 12 months ending December 31, 2015, according to IMS Health.
