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VG ☆ India, 2013-02-12 11:01 (4885 d 16:38 ago) Posting: # 10003 Views: 4,217 |
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Dear all Is BE NOC required for valacyclovir 1000 mg tablets Regards VG |
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drgunasakaran1 ★★  2013-02-13 11:10 (4884 d 16:28 ago) @ VG Posting: # 10009 Views: 3,496 |
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Dear Mr VG, Valacyclovir 1000 mg was approved by CDSCO on 25.09.2002. Hence, there is no need to get BENOC for the same. — Dr Gunasakaran Sambandan MD Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn |
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VG ☆ India, 2013-02-13 14:27 (4884 d 13:11 ago) (edited on 2013-02-13 22:01) @ drgunasakaran1 Posting: # 10013 Views: 3,502 |
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Dear Dr. Gunasakaran Thank you for the response. As per the DCGI approved Drug list Valacyclovir is approved in year 2002, but strength is not mentioned for the same. We have previously conducted study on Valacyclovir in the year 2006 during which sponsor has applied for NOC and it was not declared as No more a New drug. Regards VG Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe] |
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drgunasakaran1 ★★ 2013-02-13 18:22 (4884 d 09:17 ago) @ VG Posting: # 10016 Views: 3,494 |
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Dear Mr VG, ❝ Thank you for the response. As per the DCGI approved Drug list Valacyclovir is approved in year 2002, but strength is not mentioned for the same. CDSCO approved both 500 mg and 1000 mg in 2002 itself. You can see the availability of Valacyclovir 1000mg in MIMS, India from 2002 onwards. Reference: MIMS India You can also write a mail to DCGI seeking clarification for approval status of Valacyclovir 1000 mg. — Dr Gunasakaran Sambandan MD Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn |
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