Wednesday 4 June, 2008

Regulatory/IP update

*Watson Receives FDA Approval of Potassium Chloride Extended-Release Capsules USP in the 8mEq and 10mEq strengths.

*Boca Pharmacal Receives FDA Approval for Carbinoxamine Maleate 4 mg Tablet

*Lannett Company to Launch Amantadine Hydrochloride Soft Gel Capsules, 100 mg

*Watson Receives Final Approval of Omeprazole Delayed-Release Capsules 10mg, 20mg and 40mg

*U.S. Patent & Trademark Office (PTO) has completed the second of four reexamination proceedings and has confirmed the patentability of US5922695 which covers the composition of matter for Viread (Tenofovir Disoproxil Fumarate).

*Barr has filed Paragraph IV on Entocort Enteric Coated Capsules (Budesonide), 3mg. The Company believes that it is the first to file an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for Entocort

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Disclaimer: "IP Pharma Doc" blog is published for information purpose only. "IP Pharma Doc" blog contains no legal advice. I assume no legal responsibility for the views/information expressed here. “IP Pharma Doc” blog is my personal website and not edited by my employer, accordingly, no part of my blog should be attributed to my employer. All information on the present blog should be double checked for its accuracy and applicability. © Dr. Sarwal (2007)
 
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