US FDA grants final approval to Strides' injectible acetazolamide

Bangalore-based Strides Arcolab today said that it has received ANDA approval from US FDA for its acetazolamide for injection USP in dosages of  500 mg/ vial (preservative free) in lyophilised format.

Acetazolamide, is used for adjunctive treatment of edema due to congestive heart failure; drug-induced edema; centrencephalic epilepsies (petit mal, unlocalised seizures); chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure.

According to IMS, the 2011 U.S. market for Injectable Acetazolamide approximates to $10 million with only one active player. The product is expected to be launched shortly.

Acetazolamide is the 14th product approved under the Sagent - Strides partnership, under which strides is developing and supplying more than 25 injectable products for the US market which will be marketed by privately-held specialty pharmaceutical firm Sagent