Zydus Pharma gets USFDA nod for Roflumilast Tablets

Ahmedabad: Zydus' U.S. subsidiary Zydus Pharmaceuticals (USA) Inc. has received final approval from the US Food and Drug Administration (USFDA) to market Roflumilast Tablets in the strength of 500 mcg and a tentative approval for Roflumilast Tablets, 250 mcg (US RLD - DALIRESP).

Zydus being one of the first applicants for Roflumilast Tablets, 500 mcg is eligible for 180 days of shared generic drug exclusivity under section 505(j)(5)(B)(iv) of the FD&C Act.

Zydus' Roflumilast Tablets are indicated as a treatment to reduce the risk of chronic obstructive pulmonary disease (COPD) exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.

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COPD is a common respiratory disorder characterized by progressive airflow obstruction due to alveolar and bronchial abnormalities and inflammation caused by exposure to noxious substances. A highly debilitating disease, COPD impacts the normal daily activities and limits the quality of life. The disease is progressive in nature and can sometimes worsen due to sudden exacerbations, leading to significant disability and death.

The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad. The group now has 327 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Cadila had earlier announced the launch of Forglyn pMDI, India's first pressurized Metered Dose Inhaler (pMDI) with a combination of Long Acting Muscarinic Antagonist (LAMA) and Long Acting Beta Agonist (LABA) for patients suffering from Chronic Obstructive Pulmonary Disease (COPD) in India.

Read also: Zydus Cadila Unveils Pressurized Metered Dose Inhaler For COPD Patients In India

Zydus Cadila is a global pharmaceutical company headquartered in Ahmedabad, India. The company discovers, develops, manufactures, and markets a broad range of healthcare therapies.

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