Last week the U.S. Food and Drug Administration approved the first generic versions of Cymbalta (duloxetine delayed-release capsules), a prescription medicine used to treat fibromyalgia, chronic musculoskeletal pain, diabetic neuropathy, depression and generalized anxiety disorder.
Aurobindo Pharma Ltd., Dr. Reddy’s Laboratories Ltd., Lupin Ltd., Sun Pharma Global FZE, Teva Pharmaceuticals USA, and Torrent Pharmaceuticals Ltd. Have all received FDA approval to market duloxetine in various strengths.
“Health care professionals and consumers can be assured that these FDA-approved generic drugs have met our rigorous standards,” said Kathleen Uhl, M.D., acting director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research. “Generic drugs offer greater access to health care for many people.”
Are Generic Drugs Really the Same?
In the news release announcing the approval of generic versions of Cymb...
Generic versions of the Migraine abortive medication Zomig (zolmitriptan) — the oral tablets and orally disintegrating tablets (Zomig-ZMT) — have been approved by the FDA and are now shipping to pharmacies.
Several manufacturers are now producing generic zolmitriptan:
Glenmark Generics is producing 2.5 and 5mg oral tablets and 2.5 and 5 orally disintegrating tablets.
Apotec, Inc. is producing 2.5 and 5mg oral tablets and 2.5 and 5 orally disintegrating tablets.
Mylan Generics is producing 2.5 and 5mg oral tablets.
Zydus Pharmaceuticals is producing 2.5 and 5mg orally disintegrating tablets.
Teva Pharmaceuticals has received tentative approval for the 2.5 and 5mg oral tablets, but is not producing or shipping yet. The patent on Zomig Nasal Spray, which was approved by the FDA later than the tablets, has not yet expired, so zolmitriptan nasal spray is not yet available.
Zomig / zolmitriptan is one of the triptan medications, a Migraine abortive medication...
If you live with rheumatoid arthritis (RA), there’s a good chance that your doctor has talked to you about Biologics. For many, this class of drugs have been a lifesaver, helping them to achieve remission or such low disease activity that they are able to live a largely normal life. Many others have not responded to the Biologics currently on the market or may not be able to afford the up to $30,000 a year cost of these drugs. This may soon change, as biosimilars begins to be approved for use.
What are biosimilars?
Most types of medications are available in two types: the brand name and the generic version. When a pharmaceutical company develops a drug, they have patent protection on it for a certain number of years. After that, other companies are allowed to develop a generic version. Generic medication is chemically identical to the brand name drug and is made in the same dosages, has the same safety, strength, method of administration, and use. Although identical to th...
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