Sun Pharmaceutical Industries’ subsidiary has been granted the US Food and Drug Administration (USFDA) final approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Cymbalta, Duloxetine Delayed-Release Capsules USP, 20 mg, 30 mg and 60 mg. Duloxetine Delayed-Release Capsules USP, 20 mg, 30 mg and 60 mg are therapeutic equivalents of Eli Lilly & Company’s Cymbalta Delayed-Release Capsules.
These Capsules have annual sales of approximately $5.5 billion in the US. Duloxetine Delayed-Release Capsules USP are indicated for the treatment of major depressive disorder (MDD), generalized anxiety disorder (GAD) and diabetic peripheral neuropathic pain (DPNP). Sun Pharma’s subsidiary, being one of the first-to-file ANDAs for generic Cymbalta with a para IV certification, is eligible for shared 180-day marketing exclusivity in the US.
Sun Pharmaceutical Industries is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India, US and several other markets across the world.
These Capsules have annual sales of approximately $5.5 billion in the US. Duloxetine Delayed-Release Capsules USP are indicated for the treatment of major depressive disorder (MDD), generalized anxiety disorder (GAD) and diabetic peripheral neuropathic pain (DPNP). Sun Pharma’s subsidiary, being one of the first-to-file ANDAs for generic Cymbalta with a para IV certification, is eligible for shared 180-day marketing exclusivity in the US.
Sun Pharmaceutical Industries is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India, US and several other markets across the world.
No comments:
Post a Comment