Zydus Lifesciences gets FDA final approval for Micafungin for Injection

Zydus Lifesciences gets FDA final approval for Micafungin for Injection

Zydus Lifesciences (formerly Cadila Healthcare) has secured final approval for Micafungin for Injection, 50 mg/vial and 100 mg/vial, single-dose vials from the US Food and Drug Administration (FDA). The product is the generic version of Mycamine, and has approval for the treatment of a range of fungal infections. Besides, Micafungin for Injection, 50 mg/vial and […]

Sun Pharmaceutical wins FDA approval for generic Amphotericin B Liposome

Sun Pharmaceutical wins FDA approval for generic Amphotericin B Liposome

Sun Pharmaceutical Industries said that one of its fully-owned subsidiaries has secured final approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for generic Amphotericin B Liposome for Injection, 50 mg/vial Single-Dose Vial. According to the Indian pharma company, the generic product approval is based on AmBisome Liposome […]

Cadila Healthcare to bring Black Fungus drug AmphoTLC to India

Cadila Healthcare to bring Black Fungus drug AmphoTLC to India

Cadila Healthcare (also known as Zydus Cadila) has signed a license supply and commercialization agreement with Taiwanese pharma company TLC to commercialize the latter’s Black Fungus drug – AmphoTLC (Amphotericin B Liposome for Injection 50mg) in India. As per the terms of the deal, TLC will manufacture and supply AmphoTLC on a non-exclusive basis to […]

F2G’s olorofim gets FDA ODD for mold infections and Valley Fever

F2G’s olorofim gets FDA ODD for mold infections and Valley Fever

F2G has bagged orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for olorofim (formerly F901318) for the treatments of invasive mold infections – invasive aspergillosis and lomentospora/scedosporium infections, and also the fungal infection – coccidioidomycosis (Valley Fever). For the three infections, there are significant unmet medical needs. In November 2019, F2G […]

F2G gets olorofim breakthrough therapy status from FDA for mold infections

F2G gets olorofim breakthrough therapy status from FDA for mold infections

F2G has secured breakthrough therapy designation to olorofim (formerly F901318) from the US Food and Drug Administration (FDA)  for the treatment of certain invasive mold infections. The breakthrough therapy designation is for the use of olorofim in patients having limited or no treatment options, and also those who are intolerant to currently available therapy for […]