Biocraft receives first generic approval for cyclacillin tablets on Aug. 4. Launch is planned for the first week of September at a price to wholesalers of about $ 20 per 250 mg bottle of 100s and $ 37 per 500 mg bottle of 100s. Biocraft estimates annual sales of cyclacillin, Wyeth's Cyclapen, at $ 5 mil.
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Dr Reddy’s Laboratories has become the third Revlimid ANDA sponsor to settle patent litigation action with Bristol Myers Squibb’s Celgene. However, the Indian company will join Alvogen in not being able to launch before first settler Natco, which has partnered with Teva’s Watson.
Strides is expanding its presence in synthetic injectables via a new company, SteriScience, while keeping its biologics injectables business under Stelis. A head start with existing IP assets and those from a new joint venture with Brooks Labs will enable the fledgling firm to file its first ANDA in fiscal 2021, with break-even foreseen in two years.
The US FDA has been skeptical about remote testing, but independent consultant (and former Abbott human factors director) Ed Israelski predicts the pandemic may bring a change.