EAST WINDSOR, N.J., June 04, 2019 (GLOBE NEWSWIRE) -- Novitium Pharma LLC has received the Food and Drug Administration’s clearance for Sildenafil for Oral Suspension, 10mg/mL. The product is the generic of Pfizer’s Revatio® for Oral Suspension which is currently listed on FDA’s drug shortages list. Novitium was granted by FDA a Competitive Generic Therapy Designation for this product as they achieved approval for the first therapeutically equivalent generic. This approval marks Novitium’s third Competitive Generic Therapy Designated ANDA and seventh overall ANDA approved in 2019.
“We are pleased to announce that the launch of Sildenafil for Oral Suspension has already initiated,” said Novitium Chief Executive Officer Chad Gassert. “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.”
Revatio® for oral suspension, 10mg/ml had a market value of about $200 million for the 12 months ending March 2019, according to IQVIA.
About Novitium Pharma
Novitium is a U.S. based pharmaceutical company that specializes in development, manufacturing, and distribution of niche generic pharmaceutical products. The company, founded in 2016, has since established a growing commercial product portfolio and developed a pipeline of over 20 ANDAs filed with the FDA, spanning a diverse range of dosage forms and therapeutic categories. Novitium continues to invest in producing affordable, high-quality medications to fulfill the needs of pharmacists, patients, and communities alike.
For more information about Novitium Pharma please visit www.novitiumpharma.com.