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USFDA Approved Silodosin Capsules, 4 mg and 8 mg for the treatment of signs and symptoms of benign prostatic hyperplasia (BPH)

Nov 25, 2019: Alembic Pharmaceuticals  Abbreviated New Drug Application (ANDA) Silodosin Capsules, 4 mg and 8 mg approved by US Food & Drug Administration (USFDA).

This approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rapaflo Capsules, 4 mg and 8 mg, of Allergan Sales, LLC. Silodosin capsule, (a selective alpha1 adrenergic receptor antagonist) used for the treatment of signs and symptoms of benign prostatic hyperplasia (BPH). 

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Estimated market size of  Silodosin Capsules is  US$ 114 million for twelve months ending June 2019 according to IQVIA. https://www.alembicpharmaceuticals.com/wp-content/uploads/2019/11/Press-Release-USFDA-Approval-Silodosin-Capsules-4-mg-and-8-mg-November-2019-1.pdf

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