Lupin gets FDA nod for Fluoxetine to treat depressive disorders

Lupin's Fluoxetine Tablets USP, 60mg, is the generic version of Alvogen's Fluoxetine Tablets, 60mg. Fluoxetine 60 mg Hard Capsules are used to treat adults with major depressive episodes.

Mumbai: Pharma major Lupin announced that it has received approval for its Fluoxetine Tablets USP, 60mg, from the United States Food and Drug Administration (FDA) to market a generic version of Alvogen's Fluoxetine Tablets, 60mg.

Lupin's Fluoxetine Tablets USP, 60mg, is the generic version of Alvogen's Fluoxetine Tablets, 60mg. Fluoxetine 60 mg Hard Capsules are used to treat adults with major depressive episodes.

It is indicated in the treatment of:

Major Depressive Disorder (MDD)- Major depressive disorder (MDD), also known simply as depression, is a mental disorder characterized by at least two weeks of low mood that is present across most situations. It is often accompanied by low self-esteem, loss of interest in normally enjoyable activities, low energy, and pain without a clear cause.

Adults: Efficacy was established in one 5-week trial, three 6-week trials, and one maintenance study.
Paediatrics: Efficacy was established in two 8- to 9-week trials of patients 8 to 18 years of age.

Obsessive Compulsive Disorder (OCD)- OCD is a mental disorder where people feel the need to check things repeatedly, perform certain routines repeatedly (called "rituals"), or have certain thoughts repeatedly (called "obsessions"). People are unable to control either the thoughts or the activities for more than a short period of time. Common activities include hand washing, counting of things, and checking to see if a door is locked.

Adults: Efficacy was established in two 13-week trials.
Paediatrics: Efficacy was established in one 13-week trial in pediatric patients 7 to 17 years of age.

Bulimia Nervosa- Bulimia nervosa, also known as simply bulimia, is an eating disorder characterized by binge eating followed by purging. Binge eating refers to eating a large amount of food in a short amount of time. Purging refers to the attempts to get rid of the food consumed.

Adults: Efficacy was established in two 8-week trials and one 16-week trial.

Panic disorder, with or without agoraphobia - Panic disorder is an anxiety disorder characterized by reoccurring unexpected panic attacks. Panic attacks are sudden periods of intense fear that may include palpitations, sweating, shaking, shortness of breath, numbness, or a feeling that something terrible is going to happen.

Adults: Efficacy was established in two 12-week trials.

Fluoxetine Tablets, 60mg, had annual sales of approximately USD 42.5 million in the US (IQVIA MAT December 2018).

Lupin has been developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds a position in the Anti-TB segment.

Also Read: Lupin gets USFDA nod to Tadalafil to treat pulmonary arterial hypertension