US-based player Slayback “will kick off a full commercial launch under its own label very soon” of the generic version of Allergan’s Taytulla for which it has just received approval with a competitive generic therapy designation.
Slayback Pharma has championed the US Food and Drug Administration’s competitive generic therapy pathway after receiving approval for an AB-rated generic version of Allergan’s Taytulla (norethindrone acetate/ethinyl capsules; ferrous fumarate capsules) with the CGT designation, “less than eight months from filing.”
Final approval for Slayback’s abbreviated new drug application product, named Merzee, with a CGT designation brings the potential of 180 days of exclusivity, with the New
As financial volatility continues in the industry, Biocon’s board is considering merging its two off-patent drug businesses.
Eight more ANDA filers remain in play challenging patents shielding Esperion’s Nexletol (bempedoic acid) after Micro Labs deal out litigation via a settlement agreement.
Viatris continues to make progress on remediation at the firm’s stricken manufacturing facility in Indore, India, following a warning letter and import alert delivered at the tail end of 2024.
