EMEA issued positive opinion on clopidogrel bisulfate tablets (300 mg)
Sanofi-Aventis and Bristol-Myers Squibb Company announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Evaluation Agency (EMEA) has issued a positive opinion recommending approval of the 300mg tablet of the antiplatelet Plavix(R) (clopidogrel bisulfate). This positive opinion from the CHMP needs to be ratified by the European Commission in the coming months before final approval.The new 300mg tablet will facilitate the use of the approved loading dose of Plavix(R) and the early initiation as recommended by national and international guidelines in appropriate patients with acute coronary syndrome (ACS), including those with unstable angina / non-ST segment elevation myocardial infarction (managed with percutaneous intervention (PCI) with or without stent or medically managed) and ST segment elevation myocardial infarction patients. The 300mg tablet is bioequivalent to four 75mg tablets of Plavix(R).
Sun got tentative approval for Gemcitabine injection
Sun Pharma announced that USFDA has granted tentative approval for the Company’s Abbreviated New Drug Application (ANDA) for its generic version of Eli Lilly and Co’s Gemzar, Gemcitabine injection.These generic gemcitabine injections are therapeutic equivalents of Eli Lilly and Co’s Gemzar® injections availablein two strengths: 200 mg and 1 g single use vial. These strengths of gemcitabine injections have annual sales ofapproximately USD 680 million in the US.Gemcitabine is an anticancer, used singly or in combination with other anticancer agents.
Teva got final approval for Cetrizine, Pseudoephedrine extended release tablets
Perrigo Company announced that its partner, Teva Pharma has received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) for over-the-counter Cetirizine Hydrochloride, Pseudoephedrine Hydrochloride Extended-Release Tablets, 5 mg/120 mg.
