USFDA approves Gland Pharma’s Foscarnet

USFDA approves Gland Pharma’s generic Foscarnet Sodium Injection, single – dose bag for infusion :

Gland Pharma had sought out the USFDA’s^[1] approval for one of its generic products. This product is called Foscarnet Sodium injection, 6000 mg/ 250 mL ( 24 mg/ mL ) Single-Dose Bag for Infusion.

On 22 April 2021, the company announced that the FDA had approved this product. This approval has led to Gland Pharma securing the first generic offering status in Single – Dose Bag for Infusion.

This generic product is bioequivalent and therapeutically equivalent to Foscarnet Injection, 24 mg/ mL. Clinigen Healthcare manufactures this Reference Listed Drug (RLD).

The USFDA has granted CGT^[3] designation for Foscarnet Sodium Injection. This is because it is the first approved applicant for such competitive gene therapy. Per the FDA norms, Gland Pharma is eligible for 180 days of CGT exclusivity that will begin after the commercial launch date of the product.

Gland Pharma has an in–house API^[2] Source for this product and plans to supply it globally. The global market size of this product is estimated to be around $ 50 million. The drug firm has also launched this product in the Canadian market.

This injection is used for the treatment of cytomegalovirus ( CMV ) retinitis      in patients with AIDS^[4]. It is also indicated for the treatment of acyclovir – resistant mucocutaneous herpes simplex virus ( HSV ) infections. This drug is especially used in treating such infections in immunocompromised individuals.

Per IQVIA^[5], the US sales of this injection and its generic equivalents for 12 months ending on January 2021 is around USD^[6] 28 million.

Gland Pharma is one of the largest injectable–focused companies specializing in small volume liquid parenteral products. It manufactures a wide range of products, including vials, ampoules, infusions, oncology, and ophthalmic solutions. It has also pioneered Heparin technology in India.

Abbreviation :

• 1. United States Food and Drug Administration
• 2. Active Pharmaceutical Ingredient
• 3. Competitive Gene Therapy
• 4. Acquired Immunodeficiency Syndrome
• 5. Formerly known as Quintiles and IMS Health Inc.
• 6. United States Dollar