China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced receiving marketing approval from the US FDA for its generic version of US-based Upjohn’s lincomycin. This approval marks a significant milestone for Poly Pharm in expanding its presence in the US market.
Drug Profile and Indications
Lincomycin, first approved in the US under the trade name Lincocin in December 1964, has been approved in multiple countries in Europe as well as Japan for severe infections caused by sensitive streptococcus, pneumococcus, and staphylococcus. Its use is typically reserved for patients with penicillin allergy or those who are not suitable for penicillin, according to the doctor’s judgment.
Market Filings and Future Prospects
Poly Pharm has made market filings for the 600 mg/2mL and 3,000mg/10mL specifications in the US and China. The receipt of FDA approval positions Poly Pharm to further enhance its product offerings and address significant unmet medical needs in the treatment of severe infections. This strategic move underscores Poly Pharm’s commitment to providing high-quality generic medications to patients globally.-Fineline Info & Tech
