The U.S. Food and Drug Administration (FDA) approves Novitium Pharma’s generic sildenafil oral suspension at a dose of 10 mg/mL for pulmonary arterial hypertension (PAH) treatment.
It is the first FDA-approved generic version of Pfizer’s Revatio. Sildenafil is a selective PDE5 (phosphodiesterase type 5) inhibitor, which causes widening and relaxation of the blood vessels, improving blood flow, so that patients with PAH can breathe easier.
The FDA approved Revatio in 2005 for the treatment of PAH. Pfizer also sells Sildenafil Citrate under the brand name Viagra for the treatment of Erectile Dysfunction.
Novitium CEO Chad Gassert said in a press release, “We are pleased to announce that the launch of sildenafil for oral suspension has already initiated. Novitium remains dedicated to providing patients with a steady supply of affordable treatment options, and to progressing the availability of generics in niche therapeutic categories.”
The pharma company had submitted an abbreviated new drug application (ANDA) for the chemical, which has been filed for generic medicines seeking approval from the FDA.
Once approved, Novitium will earn the rights to manufacture and market the generic version of sildenafil as an equally safe, effective, and affordable alternative to the brand Revatio.
Currently, Revatio is on the FDA’s drug shortages list that includes those whose market needs are not met, probably due to delays in the manufacturing process or excessive market demand.
The FDA works closely with pharma companies to reduce or prevent the impact of drug shortages. According to Novitium, a New Jersey-based pharmaceutical company that specializes in developing and marketing generic drugs, “Sildenafil is its third generic product that has received the designation of competitive generic therapy, and the seventh whose ANDA has been approved this year.”
