Aurobindo Pharma has received final approvals from the US Food and Drug Administration (US FDA) to manufacture and market tamsulosin hydrochloride capsules USP 0.4mg (ANDA 202433) and clindamycin palmitate hydrochloride for oral solution USP (Paediatric), 75mg (base)/5mL (ANDA 202409).
The products will be launched soon. Tamsulosin hydrochloride capsules USP 0.4mg is the generic equivalent of Boehringer Ingelheim Pharmaceuticals’ Flomax capsules, 0.4mg and is indicated for the treatment of symptoms of an enlarged prostate (Benign Prostatic Hyperplasia – BPH) in men.
The market size of the product is estimated to be $244 million. Clindamycin palmitate hydrochloride for Oral Solution USP(Paediatric), 75mg (base)/5ml is the generic equivalent of Pharmacia and Upjohn’s Cleocin Paediatric for oral solution, 75mg (base)/5mL and is indicated for the treatment of serious infections caused by susceptible anaerobic bacteria in infants.
EP News Bureau – Mumbai
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