Strides Arcolab Limited (Strides), a Bengaluru-based global pharmaceutical company, has received ANDA approval from US FDA for acetazolamide for injection USP, 500 mg/vial (preservative free) in lyophilized format.
According to IMS, the 2011 US market for Injectable acetazolamide approximates to USD 10 million with only one active player. The product is expected to be launched shortly.
Acetazolamide is the fourteenth product approved under the Sagent - Strides partnership. Strides is developing and supplying more than 25 injectable products for the USA market which will be marketed by Sagent.
Acetazolamide, is used for adjunctive treatment of: edema due to congestive heart failure; drug-induced edema; centrencephalic epilepsies (petit mal, unlocalized 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.
Agila, Specialties business of Strides Arcolab is focused on key domains such as oncolytics, penems, pencillins, cephalosporins, ophthalmics, peptides and biosimilars and operates from 9 world-class global manufacturing facilities, including one of the largest steriles capacity in India and amongst the largest lyophilization (freeze drying) capacities in the world.