A quick view on the Generic drug approvals by US FDA this month (Nov'09).
1. Akorn Inc and Alcon Inc has obtained two generic drug approvals this year for KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION (0.4%, 0.5%); Notably, Apotex Inc and Sun Pharma has obtained one approval each (0.4%, 0.5% respectively) for the same drug.
2. One of the generic drug competitor, Barr Laboratories have got an approval on NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS (1 MG/0.005 MG)
3. Another generic drug competitor, Teva Pharmaceuticals and Matrix laboratories have obtained approval for LANSOPRAZOLE DELAYED-RELEASE CAPSULES (15 MG and 30 MG)
4. The Indian pharma company, Aurobindo Pharma and Roxane laboratories, Ivax Pharmaceuticals (a subsidiary of Teva) have got nod for PERINDOPRIL ERBUMINE TABLETS (2 MG, 4 MG and 8 MG)
5. Par pharmaceuticals got approval for TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS (100 MG and 200 MG)
6. The drug, NICARDIPINE HYDROCHLORIDE INJECTION (2.5 MG/ML; PACKAGED IN 25 MG/10 ML) was approved for Generamedix Inc, Pharmaforce Inc, Vavinta LLC, Sun pharma and Wockhardt Ltd.
7. NIZATIDINE ORAL SOLUTION (15 MG/ML) was approved to Amneal Pharmaceuticals.
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