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Approvals for Pfizer, Roche; designation for Eton Pharmaceuticals

Approvals and designations made by the U.S. Food and Drug Administration for the week ended March 15.


* Pfizer Inc.'s Trazimera, a biosimilar to Roche Holding AG's breast cancer drug Herceptin.

* Roche's Ventana assay to identify triple-negative breast cancer patients eligible for treatment with Tecentriq, or atezolizumab, in combination with Celgene Corp.'s chemotherapy drug Abraxane.

* Regeneron Pharmaceuticals Inc. and Sanofi's Dupixent injection for patients 12 to 17 years old with moderate to severe atopic dermatitis. Dupixent is already approved to treat certain adults with moderate to severe atopic dermatitis and as an add-on maintenance therapy for moderate to severe asthma.

* Alkem Laboratories Ltd.'s generic version of valsartan, a common blood pressure and heart failure drug. The generic copy was approved in an attempt to relieve shortages resulting from mass recalls of the medicine.

* Aerie Pharmaceuticals Inc.'s Rocklatan to reduce fluid pressure in the eye in patients with open-angle glaucoma or ocular hypertension.

SNL Image
FDA headquarters in Silver Spring, Md.
Source: Associated Press

Extended review

* Karyopharm Therapeutics Inc.'s Selinexor for treating recurring or unresponsive multiple myeloma. The review period was extended by three months for the FDA to review additional clinical information from a late-stage study evaluating Selinexor in combination with Takeda Pharmaceutical Co. Ltd.'s Velcade in patients with relapsed refractory multiple myeloma.

* Bavarian Nordic A/S' MVA-BN for active immunization against smallpox in adults. The review period was extended by three months as FDA needed more time to evaluate the amount of data submitted by the Denmark-based company.

Fast track

* Eton Pharmaceuticals Inc.'s DS-200, an injectable parenteral nutrition product for hospital-use.