FDA Approves First Generic Celecoxib

June/July 2014, Vol 2, No 3 - FDA Updates

The first generic versions of Celebrex (celecoxib) capsules, a treatment for patients with rheumatoid arthritis, osteoarthritis, acute pain, and other conditions, have been approved by the FDA, according to a press release by the agency.

Teva Pharmaceutical Industries received approval to market celecoxib capsules in 50-mg, 100-mg, 200-mg, and 400-mg strengths, and has 180-day exclusivity on the 100-mg, 200-mg, and 400-mg products. Mylan Pharmaceuticals Inc received approval to market 50-mg celecoxib capsules.

Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID). All NSAIDs have a boxed warning in their prescribing information to alert healthcare professionals and patients about the risk of heart attack or stroke that can lead to death. This chance increases for people with heart disease or risk factors for heart disease, such as high blood pressure, or taking NSAIDs for long periods of time. The boxed warning also highlights the risk of serious, potential life-threatening gastrointestinal bleeding that has been associated with the use of NSAIDs.

In the clinical trials for celecoxib, the most commonly reported adverse reactions in patients taking the drug for arthritis were abdominal pain, diarrhea, dyspepsia, flatulence, peripheral edema, accidental injury, dizziness, pharyngitis, rhinitis, swollen nasal passages, sinusitis, upper respiratory tract infection, and rash.
Information about the availability of generic celecoxib can be obtained from the companies.

Related Items
Once-Daily Injection Approved for Patients with Type 2 Diabetes
July 2016 - In the News published on July 29, 2016 in FDA Updates
First Oral Regimen FDA Approved for Treatment of Chronic HCV
June 2016 - In the News published on June 29, 2016 in FDA Updates
Nuplazid Approved for Psychosis-Associated Hallucinations in Patients with Parkinson’s Disease
May 2016 - In the News published on May 25, 2016 in FDA Updates
FDA Approves First Generic Version of Crestor for Multiple Indications in Adults
May 2016 - In the News published on May 25, 2016 in FDA Updates
FDA Enhances Warnings for Serious Risks of Opioid Analgesics Abuse
April 2016 - In the News published on April 26, 2016 in FDA Updates
Obiltoxaximab FDA-Approved to Treat and Prevent Inhalation Anthrax
March 2016 - In the News published on March 24, 2016 in FDA Updates
FDA Approves First Coagulation Factor-Albumin Fusion Protein to Treat Patients with Hemophilia B
March 2016 - In the News published on March 21, 2016 in FDA Updates
FDA Approves Briviact to Treat Partial Onset Seizures
March 2016 - In the News published on March 21, 2016 in FDA Updates
FDA Approves Integra Omnigraft Dermal Regeneration Matrix to Treat Diabetic Foot Ulcers
January 2016 - In the News published on January 12, 2016 in FDA Updates
FDA Approves Basaglar, the First “Follow-On” Insulin Glargine Product to Treat Diabetes
January 2016 - In the News published on January 6, 2016 in FDA Updates
Last modified: May 21, 2015
  • American Health & Drug Benefits
  • The Journal of Hematology Oncology Pharmacy
  • Lynx CME
  • The Oncology Pharmacist

Search