Zydus Cadila gets USFDA’s approval to market diabetes medication

INDIA – Drug firm Zydus Cadila has received approval from the US health regulator to market Sitagliptin, a medicine indicated to treat diabetes.

The company said its subsidiary has received tentative approval from the United States Food and Drug Administration (FDA) for its new drug application for Sitagliptin base 25, 50 and 100 mg tablets.

On October 31, 2020, Zydus had filed a new drug application (NDA) with the USFDA seeking approval to market Sitagliptin base 25, 50 and 100 mg tablets.

The NDA received tentative approval upon completion of the first review cycle on September 2, 2021, Zydus Cadila stated.

The company has been making major progress in launching and commercializing various drugs in the market.

In August, Zydus Pharmaceuticals, USA, signed a license and supply agreement with Italy’s CHEMI SpA or CHEMI – a subsidiary of Italfarmaco Group, to launch the Enoxaparin Sodium injection in the United States (US). The injection is usually given to patients undergoing abdominal, knee or hip replacement surgery.

The product is a generic equivalent of Sanofi Aventis’s branded product Lovenox, according to a regulatory filing by Cadila Healthcare to the stock exchanges today. Zydus Pharma Inc, USA is a 100 percent subsidiary of Cadila Healthcare Limited or Zydus Cadila.

As part of the agreement, CHEMI will manufacture and supply the Enoxaparin Sodium injection which Zydus Cadila will commercialize in the United States. Utilising their proprietary technology, CHEMI will produce the Enoxaparin Sodium injection within the proprietary manufacturing facilities situated in Italy.

The leading specialty pharmaceutical company owns the proprietary rights on a pharmaceutical product composed of preservative-free Enoxaparin Sodium single-use pre-filled syringes, according to the statement.

Zydus, which discovers, develops, manufactures, and markets a broad range of healthcare therapies including small molecule drugs, biologic therapeutics, and vaccines, has not been left behind in the Covid-19 vaccine bandwagon.

Zydus launched ZyCov-D, a three-dose Covid-19 vaccine which received approval last month. ZyCoV-D is the first vaccine in India also permitted for 12-17-year old’s apart from adults.

It has also been touted as a needle free vaccine that can be administered with an applicator which ensures painless intra-dermal vaccine delivery.

Zydus Cadila’s vaccine is the second home-grown shot to get emergency authorization in India after Bharat Biotech’s Covaxin.

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