FDA Approvals And Changes For The Week Ending February 14, 2014
The week ending February 14 was a nightmare for the Food and Drug Administration, as numerous companies sought not only manufacturing changes, but drug approvals as well. Below are some of the more notable changes and approvals.
Some companies that sought after manufacturing changes include: Amylin (NASDAQ: AMLN) with its Byetta, which is an injectabe drug. Pfizer (NYSE: PFE) with its Children's Advil, which is a tablet and Amarin Pharmaceuticals (NASDAQ: AMRN) with its Vascepa, which is a capsule.
Sun Pharma Global had its drug Temozolomide approved. The company is based outside of the United States and and had its consolidated net profit increase by 74 percent.
Pharmacyclics (NASDAQ: PCYC) sought drug approval with its Imbruvica. The drug is meant to help patients who have leukemia. The stock traded at $133.28 before this week's open, after having been down $5.58 or four percent.
Innopharma Licensing had its drug Acetylcysteine approved.
Macleods Pharms had its drug Rizatriptan Benozate approved; it is currently not trading publicly on any stock exchange.
ACIC Fine Chemicals had its drug Tranexamic Acid approved.
Akorn (NASDAQ: AKRX) had its drug Ketorolac Tromethamine approved; the stock is was trading at $24.00 at week's open and has a PE of 60.
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