Alembic Pharma receives USFDA very last nod for Fulvestrant Injection by admin- Monday, December 26th, 2022 03:21:16 PM
Alembic Pharmaceuticals acquired very last approval from the USA Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Fulvestrant Injection, 250 mg/five mL (50 mg/mL) in step with SingleDose Prefilled Syringe. The permitted ANDA is therapeutically equivalent to the reference indexed drug product (RLD), Faslodex Injection, 250 mg/5 mL (50 mg/mL), of AstraZeneca Pharmaceuticals LP. Fulvestrant Injection is an estrogen receptor antagonist indicated for the treatment of breast cancer. Refer to our label for full indication.
Fulvestrant Injection, 250 mg/five mL, has an expected marketplace length of US$71 million for twelve months finishing Sep 2022 in keeping with IQVIA.