NEWS FROM USA
505(b)2 NDA APPROVALS
|
Approval Date |
Product Name |
NDA Sponsor |
Brand Name |
Prescribing information |
|
17 May 2019 |
Midazolam Nasal Spray |
Proximagen |
Nayzilam |
New PED (pediatric) exclusivity listing in the orange book
|
Drug |
Innovator |
Brand Name |
PED exclusivity expiration date |
|
Tavaborole topical solution |
Anacor Pharma |
Kerydin |
*Because of PED, NCE exclusivity of Tavaborole is extended by 6 months. Earlier NCE exclusivity of Tavaborole was set to expire on 7 July 2019.
ANDA APPROVALS
|
Approval Date |
Drug Product |
ANDA Sponsor |
Corresponding RLD |
Number Of Other Approved Generics |
|
14 May 2019 |
Sandoz |
Faslodex (Astrazeneca) |
One (Amneal) |
|
|
14 May 2019 |
Edenbridge Pharms |
Albenza (Impax) |
Three |
|
|
14 May 2019 |
Sandoz |
Glycopyrrolate (West-Ward) |
Ten |
|
|
15 May 2019 |
Shilpa Medicare |
Zometa (Novartis) |
More Than 10 |
|
|
16 May 2019 |
Shilpa Medicare |
Taxotere (Sanofi) |
Eight |
|
|
20 May 2019 |
Panacea Biotec |
Vidaza (Celgene) |
Eight |
TENTATIVE ANDA APPROVALS
|
Approval Date |
Drug |
Company |
|
17 May 2019 |
Teva |
|
|
17 May 2019 |
Alkem |
|
|
17 May 2019 |
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate |
Sun Pharma |
USFDA INSPECTION
Cipla (Indore facility): Cipla provided update on USFDA inspection at Indore Indore manufacturing facility
- USFDA conducted a post-approval inspection at our Indore facility from 13th May to 17th May, 2019.
- The inspection was ended with zero observation.
- Press Release: Link
Alkem Lab (Baddi Facility): Alkem provided update on USFDA inspection at Baddi manufacturing facility.
- USFDA had conducted an inspection at the Company's manufacturing facility located at Baddi, India from 13th May, 2019 to 17th May, 2019.
- At the end of the inspection, Company has received a Form 483 with four (4) observations.
- Press Release: Link
Aurobindo (Unit I, IX and XI): Aurobindo provided update on USFDA inspection at API manufacturing facilities.
- Aurobindo has received letters from the USFDA classifying the inspections concluded at our API facilities of Unit I and XI and intermediates facility of unit IX in February 2019 as Official Action Indicated (OAI).
- The Company has already submitted its initial response to USFDA.
- The Company said they are confident that these OAI classifications will not have an impact on disruption of supplies or the revenue from operations of these facilities.
- Press Release: Link
Lupin (Aurangabad Facility): U.S. FDA completes inspection of Lupin’s Aurangabad facility.
- The inspection was carried out from May 6 to May 15, 2019.
- The inspection at the Aurangabad facility closed with three observations.
- Press Release: Link
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