Alembic Pharma gets USFDA nod for generic drug to treat breast cancer

The approved injectable is therapeutically equal to AstraZeneca Pharmaceuticals LP's Faslodex Injection, which is a reference listed drug product (RLD). According to a statement from the firm, the US Food & Drug Administration (USFDA) has approved the abbreviated new drug application (ANDA), Fulvestrant injectable, with a strength of 250 mg/5 mL (50 mg/mL) per single-dose prefilled syringe. The approved injectable is therapeutically equal to AstraZeneca Pharmaceuticals LP's Faslodex Injection, which is a reference listed drug product (RLD). According to the manufacturer, fulvestrant injection is an oestrogen receptor antagonist that can be used to treat breast cancer. The business, citing IQVIA data, estimated the market size for fulvestrant injection, 250 mg/5 mL, at USD 71 million for the twelve months ending September 2022. There are many different clinical trials that are being conducted in the field of breast cancer. These trials may be testing new treatments, such as drugs or therapies, or they may be evaluating different ways of delivering existing treatments to see if they are more effective. Some examples of clinical trials that may be relevant to breast cancer include:

• Phase 1 trials: These are the earliest stage of clinical trials and are usually small in size. They are designed to test the safety and dosage of a new treatment.
• Phase 2 trials: These trials involve a larger group of people and are designed to evaluate the effectiveness of the treatment being tested.
• Phase 3 trials: These are large, randomized controlled trials that compare the new treatment being tested to the current standard of care. They are designed to determine whether the new treatment is more effective than the current standard of care.
• Phase 4 trials: These trials are conducted after a treatment has been approved by regulatory agencies and is being used in clinical practice. They are designed to monitor the long-term safety and effectiveness of the treatment.

Some specific examples of clinical trials that are currently being conducted in the field of breast cancer include studies evaluating new chemotherapy regimens, targeted therapies, immunotherapies, and hormonal therapies. There are also clinical trials evaluating different types of surgery, such as breast-conserving surgery versus mastectomy, and different types of radiation therapy.