Gland Pharma gets USFDA nod for Foscarnet Sodium injection

The product is indicated for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS).

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Medicine Injection Vaccine
Picture: Pixabay

Drug firm Gland Pharma on Thursday said it has received approval from the US health regulator for its generic Foscarnet Sodium injection indicated for treatment of cytomegalovirus retinitis in patients with AIDS.

The company has received “approval from the United States Food and Drug Administration (USFDA) for its Foscarnet Sodium injection, 6000 mg/250 mL (24 mg/mL) single-dose bag for infusion”, Gland Pharma said in a regulatory filing.


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FDA

The product is a generic version of Clinigen Healthcare”s Foscavir injection, 24 mg/mL. Gland Pharm was granted a competitive generic therapy (CGT) designation for Foscarnet Sodium injection and therefore is eligible for 180 days of CGT exclusivity, the filing said.

This exclusivity will begin only after the commercial launch date.

According to IQVIA, 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, the filing said.

The product 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.

Shares of Gland Pharma Ltd closed at Rs 2,657.95 per scrip on BSE, up 0.58 percent from its previous close.


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