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00 h) during four weeks, 7 days/week, and (2) young experimental animals, receiving the same injection volume added with recombinant human GH (rHGH, Omnitrope, Sandoz, Spain) (1 mg/k b.
Charles Sklar of Memorial Sloan Kettering Cancer Center in Manhattan reported honorarium from Sandoz, makers of the GH product Omnitrope.
The first was the 2007 challenge to Pfizer's human growth hormone drug Genotropin by Omnitrope, produced by Sandoz:
Nutropin AQ and Omnitrope provide liquid GH in prefilled cartridges, and Norditropin NordiFlex (30 mg formulation), Norditropin FlexPro (5, 10, and 15 mg formulation), and Nutropin AQ Nuspin provide prefilled, ready-to-use pens (see Table 2).
See McCamish, supra note 13, at 13 (reporting adverse event data for the Sandoz biologic products: Binocrit, Abseamed, Epoetin Alfa Hexal, Omnitrope, Zarzio); Sumant Ramachandra, Senior V.
Sandoz has already guided Omnitrope through regulatory submissions and has started on other molecules.
Sandoz' Omnitrope (somatropin), for example, accounts for less than 5% of the US growth hormones market.
s Humatrope, Novo Nordisk A/S's Norditropin, Roche Holding AG's NutropinAQ, Novartis generics unit Sandoz's Omnitrope, EMD Serono's Saizen, and Teva Pharmaceutical Industries Ltd.
Sandoz also received market authorization for Omnitrope (somatotropin) in Canada, where it is the first biosimilar of a previously approved recombinant drug to be approved by Health Canada under the Information and Submission Requirements for Subsequent Entry Biologics' provisions.
protein omnitrope, a growth hormone regulated as a drug under the FDCA.
In 2006, the FDA approved a follow-on of the recombinant human growth hormone Omnitrope, manufactured by Sandoz, but the agency said it considered that product to be not a generic but instead a "follow-on protein product," because it had made no determination of therapeutic equivalence.
In Europe, competition in these key classes has begun with the launch of the hGH biosimilar Omnitrope this year, and will continue with biogeneric launches in the other classes in 2007 and 2008.
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