Zydus Cadila gets US FDA nod for Isosorbide Dinitrate tablets, Desonide Cream

Drug firm Zydus Cadila said it has received approval from the US health regulator to market Isosorbide Dinitrate tablets used to prevent attacks of chest pain.

The drug firm has also received final approval from US health regulator for Desonide Cream, used to treat a variety of skin conditions like eczema, dermatitis, allergies and rash, the company said in a filing to BSE.

“Zydus Cadila has received the final approval from the US FDA to market Isosorbide Dinitrate tablets USP in the strengths of 5 mg, 10 mg, 20 mg, 30 mg and 40 mg,” the filing said.

The drug is used to prevent attacks of chest pain. lt dilates blood vessels, making it easier for blood to flow through them and easier for the heart to pump.It will be manufactured at the Group’s formulations manufacturing facility at Baddi, Himachal Pradesh.

“The group also received the final approval for Desonide Cream (US RLD – Desonide Cream), 0.05 per cent,” the filing said.

The drug is a mild corticosteroid, used to treat a variety of skin conditions like eczema, dermatitis, allergies and rash, to reduce swelling, itching and redness that can occur in these types of conditions.

It will be manufactured at the Group’s topical manufacturing facility at Ahmedabad, it said.
The shares of Cadila Healthcare, the listed entity of the group, were trading at Rs 251.35, higher by 0.92 per cent on the BSE.