FDA Approves Novitium Pharma’s Generic Sildenafil for PAH Treatment

Joana Carvalho, PhD avatar

by Joana Carvalho, PhD |

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The U.S. Food and Drug Administration (FDA) has approved Novitium Pharma‘s generic sildenafil for oral suspension at a dose of 10 mg/mL for the treatment of pulmonary arterial hypertension (PAH).

This product, which had been designated a competitive generic therapy by the FDA, is the first approved generic equivalent to Pfizer‘s Revatio, a vasodilator agent that induces blood vessel widening and relaxation to help patients breathe better.

Revatio was approved in 2005 by the FDA for the treatment of PAH, specifically for those patients classified in the World Health organization (WHO) Group 1.

“We are pleased to announce that the launch of sildenafil for oral suspension has already initiated,” Chad Gassert, CEO of Novitium, said in a press release. “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.”

Novitium had submitted an abbreviated new drug application (ANDA) for the compound, which is filed for generic medications seeking FDA approval. Once approved, the company earns the rights to manufacture and market the therapy as an equally safe, effective, and less expensive alternative to the brand-name product — in this case, Revatio.

The FDA can attribute the competitive generic therapy designation to any medication for which they determine there is inadequate generic competition, or in other words, that there is not more than one approved therapy in the active section of the FDA’s Orange Book. Medicines receiving this designation are eligible for accelerated development and review of their ANDA application.

Revatio is currently included on the FDA’s drug shortages list, which includes those whose market requirements are not being met, either due to delays in the manufacturing process or due to excessive market demand. The FDA works closely with drug manufacturers to prevent or reduce the impact of shortages in treatments.

According to Novitium, a pharmaceutical company based in the U.S. that specializes in the development and marketing of generic therapies, 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.