Gland Pharma Received Approval from USFDA for its Blood Pressure Drug

• Gland Pharma received USFDA approval for its generic version of Angiotensin II Acetate injection.
• The company secured First-To-File status, earning 180 days of exclusivity in the US market.
• Shares rose over 2% intraday on the NSE following the approval announcement.

Gland Pharma Limited saw its shares rise nearly 3% during intraday trading on Wednesday following the announcement of a major regulatory accomplishment.

The company has received approval from the US Food and Drug Administration (USFDA) for it Angiotensin II Acetate Injection, 2.5 mg/mL, a drug used to increase blood pressure in adults who are experiencing septic or other distributive shock. By 3:19 PM, the stock was trading at ?1,624.60 on the NSE, up 2.25% from its previous close of ?1,588.90, after reaching an intraday high of ?1,638. 

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In its exchange filing, Gland Pharma confirmed that the approved product is the generic version of GIAPREZA, which was originally developed by La Jolla Pharma LLC. The company stated the formulation is both bioequivalent and therapeutically equivalent to the reference drug. Also, Gland Pharma received First-To-File (FTF) status for this product, which gives the company 180 days of marketing exclusivity for the generic version in the US market.