- Home
- Medical news & Guidelines
- Anesthesiology
- Cardiology and CTVS
- Critical Care
- Dentistry
- Dermatology
- Diabetes and Endocrinology
- ENT
- Gastroenterology
- Medicine
- Nephrology
- Neurology
- Obstretics-Gynaecology
- Oncology
- Ophthalmology
- Orthopaedics
- Pediatrics-Neonatology
- Psychiatry
- Pulmonology
- Radiology
- Surgery
- Urology
- Laboratory Medicine
- Diet
- Nursing
- Paramedical
- Physiotherapy
- Health news
- AYUSH
- State News
- Andaman and Nicobar Islands
- Andhra Pradesh
- Arunachal Pradesh
- Assam
- Bihar
- Chandigarh
- Chattisgarh
- Dadra and Nagar Haveli
- Daman and Diu
- Delhi
- Goa
- Gujarat
- Haryana
- Himachal Pradesh
- Jammu & Kashmir
- Jharkhand
- Karnataka
- Kerala
- Ladakh
- Lakshadweep
- Madhya Pradesh
- Maharashtra
- Manipur
- Meghalaya
- Mizoram
- Nagaland
- Odisha
- Puducherry
- Punjab
- Rajasthan
- Sikkim
- Tamil Nadu
- Telangana
- Tripura
- Uttar Pradesh
- Uttrakhand
- West Bengal
- Medical Education
- Industry
Gland Pharma bags USFDA nod for generic Foscarnet Sodium Injection
![Gland Pharma bags USFDA nod for generic Foscarnet Sodium Injection Gland Pharma bags USFDA nod for generic Foscarnet Sodium Injection](https://medicaldialogues.in/h-upload/2020/04/28/750x450_127916-125969-usfda-approved.webp)
Foscarnet Sodium Injection is indicated for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS).
Hyderabad: Gland Pharma Limited has recently announced that the company has received approval from the United States Food and Drug Administration (USFDA) for generic Foscarnet Sodium Injection, 6000 mg/250 mL (24 mg/mL) Single-Dose Bag for Infusion.
Generic Foscarnet Sodium Injection is the bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Foscavir Injection, 24 mg/mL, of Clinigen Healthcare Limited.
With this approval, Gland Pharma secured the first generic offering status in Single-Dose Bag for Infusion. Gland Pharma Limited was granted a Competitive Generic Therapy (CGT) designation for Foscarnet Sodium Injection as it is the "first approved applicant" for such competitive generic therapy, as per US FDA norms and therefore, is eligible for 180 days of CGT exclusivity. This exclusivity will begin only after commercial launch date and as per criteria set out by USFDA. Gland Pharma is backward integrated with in-house API source for this product.
Foscarnet Sodium Injection is indicated for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS). It is also used for the treatment of acyclovir-resistant mucocutaneous herpes simplex virus (HSV) infections in immunocompromised patients.
The Foscarnet Sodium Injection, 6000 mg/250 mL (24 mg/mL) and its generic equivalents had US sales of approximately USD 28 million for twelve months ending in January 2021, according to IQVIA.
Gland Pharma intends to supply this product globally and recently launched the product in the Canadian market. Global markets size is estimated to be USD 50 million.
Read also: Gland Pharma inks pact with RDIF for 252 million Sputnik V doses
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751