Traditional Drug Pipeline Update: February 2022

New drugs, new indications and news of note

This monthly pipeline wrap up provides a review of newly approved traditional drugs, recent drug launches, generic updates, new indications and news of note on drugs in the approval process. See separate article for pipeline information on specialty drugs.

New drug information

• Fleqsuvy™ (baclofen): The United States Food and Drug Administration (FDA) approved Azurity Pharmaceuticals’ Fleqsuvy (baclofen) as a 25mg per 5 mL (5mg/mL), concentrated formulation for the treatment of spasticity from multiple sclerosis (MS) or patients with spinal cord injuries and other spinal cord diseases. Fleqsuvy was approved via the 505(b)(2) pathway using Novartis’ Lioresal^® (baclofen) as a reference product. Fleqsuvy is a grape-flavored oral suspension formulation, that is available in bottles of either 120 or 300 mL. Fleqsuvy has launched with an average wholesale price (AWP) of $792 (120 mL) – $1,980 (300 mL) per bottle.

Generic drug information

• Isodax^® (romidepsin for injection)+: Fresenius Kabi launched their generic version of BMS’s Isodax, as a histone deacetylase (HDAC) inhibitor indicated for treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy. United States annual sales are unknown.
• Restasis^® (cyclosporine ophthalmic emulsion) 0.05%: Mylan Pharmaceuticals has launched their generic version of Allergan’s Restasis^® (cyclosporine ophthalmic emulsion) 0.05% as a topical immunomodulator indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye). There are no remaining legal or regulatory barriers and multiple manufacturers are planning to launch their generic versions this year. Restasis generated $2.547 million in U.S. annual sales in 2021.
• Cystadane^® (betaine powder for oral soln)+: Oakrum Pharma’s has launched their first generic of Recordati Rare Disease’s Cystadane which is indicated for treatment of homocystinuria to decrease elevated homocysteine blood levels. Cystadane U.S. annual sales are unknown.
• Selzentry^® tablets (maraviroc): Camber Pharmaceuticals has launched their generic version of ViiV Healthcare’s Selzentry for treatment of HIV. Selzentry oral solution does not currently have a generic available. Selzentry generated $75 million in U.S. annual sales in 2021.

+Specialty medication

References

1. https://www.prnewswire.com/news-releases/azurity-pharmaceuticals-inc-announces-fda-approval-of-fleqsuvy-baclofen-oral-suspension-301476187.html