Alembic Pharma receives USFDA nod for Doxepin Hydrochloride Capsules by admin- Friday, April 23rd, 2021 04:44:49 PM
Alembic Pharmaceuticals received final approval from the USA Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Doxepin Hydrochloride Capsules USP, 10 mg, 25 mg, 50 mg, seventy five mg and 100 mg. The approved ANDA is therapeutically equal to the reference listed drug product (RLD), Sinequan Capsules 10 mg, 25 mg, 50 mg, 75 mg, and a hundred mg, of Pfizer Inc. (Pfizer). Doxepin Hydrochloride Capsules are endorsed for the remedy of: i) Psychoneurotic sufferers with melancholy and/or anxiety, ii) Depression and/or anxiety related to alcoholism (now not to be taken concomitantly with alcohol), iii) Depression and/or anxiety associated with organic disorder (the possibility of drug interaction need to be considered if the patient is receiving different capsules concomitantly), iv) Psychotic depressive issues with related anxiety such as involutional melancholy and manic-depressive problems.
Doxepin Hydrochloride Capsules USP, 10 mg, 25 mg, 50 mg, 75 mg, and one hundred mg have an predicted marketplace size of US$ 41 million for one year finishing December 2020 according to IQVIA.