Mylan launches generic Cleocin solution
Product is indicated for the treatment of serious infections caused by susceptible anaerobic bacteria and susceptible strains of streptococci, pneumococci and staphylococci.
Mylan has announced the US 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 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 US sales of approximately $30.9 million for the 12 months ending 31 March 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 31 December 2015, according to IMS Health.
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