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EAST WINDSOR, N.J. – Aurobindo has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application for doxepin hydrochloride capsules, 10 mg, 25 mg, 50 mg, 75 mg and 100 mg. Aurobindo’s doxepin hydrochloride capsules are an AB-rated generic equivalent to the reference listed drug, Pfizer’s Sinequan.
Doxepin Hydrochloride Capsules are recommended for the treatment of:
• Psychoneurotic patients with depression and/or anxiety.
• Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol).
• Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly).
• Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders.
The target symptoms of psychoneurosis that respond particularly well to doxepin hydrochloride capsules include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry.
Doxepin hydrochloride capsules has an estimated market size of $48M for the twelve months ending February 2019 according to IMS.
