Break till June 2010

Dear Friends,

Offlate i had been out of blogging circuit and would not be able to blog till June 2010. I sincerely apologize to my friends for not being active for so long. I'll again come back in June 2010 with the updates.

Best regards,
IPBlogger.

Glenmark's Oxycodone HCl NDA for capsules and liquid solution under FDA review

The USFDA has completed the filing review for NDA's for oxycodone hydrochloride capsules, and liquid solution of Glenmark Generics Inc., USA. The NDA was submitted by GGI's partner Lehigh Valley Technologies (LVT). The US FDA in a letter to the company indicated that it has begun reviewing the application for oxycodone hydrochloride. Total sales for oxycodone hydrochloride capsules and liquid solution in the twelve month period ending December 2009 were USD 16 million as reported by IMS Health. Pursuant to the Prescription Drug User Fee Act (PDUFA) guidelines, once an NDA is accepted for filing, it is expected that the FDA will complete its review and provide an action letter with respect to the NDA within 10 months following submission of the NDA.

Synthon sued for generic tadalafil and believes to be "FTF" for 180 days exclusivity

Synthon has been sued by Eli Lilly and Icos Corporation in connection with the filing of Synthon's ANDA for Tadalafil 20 mg. Synthon's Tadalafil 20 mg Tablets product is a generic and bioequivalent version of Lilly's and United Therapeutics’ Adcirca® tablets which is indicated for the treatment of pulmonary arterial hypertension to improve exercise ability. Synthon believes that it is the ’Single First Filer’ of an ANDA with a Paragraph IV certification for the Adcirca® (Tadalafil) tablets, 20 mg. As a result, Synthon expects to be eligible for 180 days of Hatch-Waxman exclusivity upon the first commercial marketing of their generic drug product.

Teva Settles Generic Eloxatin Litigation

Patent infringement litigation pertaining to Teva's generic version of sanofi-aventis and Debiopharm's Eloxatin (oxaliplatin injection) has been dismissed by the United States District Court for the District of New Jersey pursuant to a settlement between the parties. The settlement, which provides for a full release of Teva, includes an injunction prohibiting Teva from selling its oxaliplatin injection product and a license to reenter the market at a later point in time. Teva anticipates continued sales of its oxaliplatin injection at least through June 30, 2010, and will resume shipping additional units August 9, 2012, subject to acceleration under certain contingencies.

Dear Friends

Dear Friends and fellow members,

After a long break of almost a month, i've come back. Sorry for the inconvenience. IPBlogger shall provide you updates time to time.

Best regards,
IPBlogger.