Cubist Pharmaceuticals (CBST) Granted QIDP Designation from FDA on Two Candidates

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) said the FDA designated two of the company's Phase 3 antibiotic candidates, CXA-201 (ceftolozane/tazobactam) and CB-315, as Qualified Infectious Disease Products (QIDP).

The QIDP designations will enable Cubist to benefit from certain incentives for the development of new antibiotics, including priority review, eligibility for fast-track status, and if CXA-201 or CB-315 are ultimately approved by the FDA, a five year extension of Hatch-Waxman exclusivity. These incentives are provided under the Generating Antibiotic Incentives Now Act (GAIN Act), which received strong bipartisan support in Congress and was signed into law by President Obama in July 2012 as part of the FDA Safety and Innovation Act (FDASIA), the fifth authorization of the Prescription Drug User Fee Act.

---

Serious News for Serious Traders! Try StreetInsider.com Premium Free!

---

You May Also Be Interested In

• FDA authorizes 11 ZYN Ultra nicotine pouches for Philip Morris
• FDA clears Implantica's RefluxStop implant for U.S. market
• AC Immune reports early Phase 1 data for NLRP3 inhibitor ACI-19764