First-Time Generics Approved in October

Generic drugs approved by US Food and Drug Administration in October 2015

/ Author:  / Reviewed by: Jennifer Gershman, PharmD, CPh

(RxWiki News) Several generic versions of brand-name medications received US Food and Drug Administration (FDA) approval last month.

The FDA regularly approves generic versions of brand-name drugs if they appear safe and effective for patients. Generics are generally less expensive than brand-name medications.

"All generic drugs approved by FDA have the same high quality, strength, purity and stability as brand-name drugs," according to the FDA. "And, the generic manufacturing, packaging, and testing sites must pass the same quality standards as those of brand-name drugs."

The FDA approved the following generic drugs in October:

  • Teva Pharmaceuticals USA and Sandoz Inc. both received approval for palonosetron hydrochloride injection (brand name Aloxi Injection) to prevent nausea from chemotherapy.
  • Macleods Pharmaceuticals and Silarx Pharmaceuticals Inc. both got the FDA OK for memantine hydrochloride oral solution (brand name Namenda Oral Solution) to treat dementia patients.
  • The University of Texas MD Anderson Cancer Center's choline C11 injection (brand name Choline C11 Injection) was approved for use during imaging tests to detect prostate cancer.
  • Amneal Pharmaceuticals' itraconazole oral solution (brand name Sporanox Oral Solution) was approved as an antifungal.
  • Morphine sulfate oral solution (same brand name), from Vintage Pharmaceuticals, got the FDA green light as a painkiller.

Generic drugs are exact "copies" of brand-name medications, according to the FDA. Speak to a pharmacist or doctor about warnings and possible side effects for new medications.

Review Date: 
November 3, 2015
Last Updated:
November 4, 2015