Examples of Paragraph IV Certification Notice in a sentence
Based on Absorica’s strong sales performance to-date, Cipher expects to achieve a US$10.0 million milestone payment by the end of Q1 2014 at the latest (50% of which would be shared with its technology partner, Galephar Pharmaceutical Research).In September 2013, Cipher’s partner Ranbaxy received a Paragraph IV Certification Notice of filing from Watson Laboratories Inc.
On September 4, 2009, MDCO announced that it had received a Paragraph IV Certification Notice Letter from Teva notifying MDCO that Teva had submitted ANDAs to the Food and Drug Administration for approval to market generic versions of Angiomax®.
Background on the litigation now settled On February 10, 2009, Cubist announced that it had received a Paragraph IV Certification Notice Letter from TPM notifying Cubist that TPM had submitted an ANDA to the FDA for approval to market a generic version of CUBICIN.
LEGAL PROCEEDINGSOn September 17, 2013, Ranbaxy, received a Paragraph IV Certification Notice of filing from Watson of an ANDA to the FDA for a generic version of Absorica™ (isotretinoin capsules).
Except as set forth in Section 3.22 of the Disclosure Schedule, Seller has not received or been notified in writing or, to Seller’s Knowledge, orally of any Paragraph IV Certification Notice in accordance with 21 U.S.C. § 355(j)(2)(B) advising Seller of the filing of an Abbreviated New Drug Application with respect to the Product (“ANDA”).
No Seller Party has received or been notified of and has knowledge of any Paragraph IV Certification Notice in accordance with 21 U.S.C. § 355(j)(2)(B)(ii) advising such Seller Party of the filing by an Abbreviated New Drug Application with respect to the Product (“ANDA”).
In September 2009 and April 2010, MDCO received Paragraph IV Certification Notice Letters from APP notifying MDCO that APP had submitted an ANDA to the Food and Drug Administration for approval to market a generic version of Angiomax®.
The Seller has not received or been notified of and has no knowledge of any Paragraph IV Certification Notice in accordance with 21 U.S.C. § 355(j)(2)(B)(ii) advising either the Seller or the owner or assignee of the Seller Licensed Patents of the filing by an Abbreviated New Drug Application with respect to the Product (“ANDA”).
In September 2013, Ranbaxy received a Paragraph IV Certification Notice of filing from Wxxxxx Laboratories, Inc.
The overall U.S. isotretinoin market also continues to show growth, with prescriptions increasing by 15%(3) in 2013 and by 14%(4) in Q4 2013 over the comparable period in the prior year.In September 2013, Cipher’s partner Ranbaxy received a Paragraph IV Certification Notice of filing from Watson Laboratories Inc.